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Version 1.0
Draft
[Not for implementation and published for
comment purposes]
Date of publication D/M/Y
Date of implementation D/M/Y
Saudi FDA classification guidance
2
Saudi FDA classification guidance
Version 1.0
Saudi Food & Drug Authority
Kingdom of Saudi Arabia
Please review and send your comments and suggestions within 90
days of publication to
Please visit SFDA’s website at www.sfda.gov.sa for the latest
update
SFDA
Vision and Mission
3
Vision
To be the leading regional regulatory authority for food, drugs and medical
devices with professional and excellent services that contributes to the
protection and advancement of the health in Saudi Arabia.
Mission
To ensure the safety of food; the safety, quality and efficacy of drugs; and
the safety and effectiveness of medical devices, by developing and enforcing
an appropriate regulatory system.
Document Control
Version Author Date Comments
DD/MM/YYYY
4
Table of Contents 1
1. INTRODUCTION .......................................................................................................................... 6 2
1.1 OBJECTIVES .................................................................................................................................. 6 3
1.2 BACKGROUND............................................................................................................................... 6 4
1.3 SCOPE ............................................................................................................................................ 6 5
1.4 GENERAL PRINCIPLES .................................................................................................................. 6 6
1.5 DEFINITIONS ................................................................................................................................. 7 7
2 FOOD ............................................................................................................................................. 9 8
3 DRUG ........................................................................................................................................... 11 9
3.1. HUMAN DRUG ............................................................................................................................. 11 10
3.2. HERBAL AND HEALTH PRODUCTS ............................................................................................. 12 11 3.2.1. Herbal product ....................................................................................................................12 12 3.2.2. Health product: ..................................................................................................................13 13
3.3. VETERINARY DRUGS .................................................................................................................. 14 14
3.3.1. Veterinary Medicinal Product ............................................................................................14 15 3.3.2. Insecticides .........................................................................................................................14 16 3.3.3. Shampoos ............................................................................................................................14 17 3.3.4. Teat and Udder Products....................................................................................................14 18 3.3.5. Herbal Products ..................................................................................................................15 19 3.3.6. Diagnostic Tools (Testing Kits) ..........................................................................................15 20
4 COSMETIC PRODUCTS ............................................................................................................ 16 21
4.1 SKIN PRODUCTS ......................................................................................................................... 16 22
4.2 CLASSIFICATION CRITERIA OF COSMETIC PRODUCTS: ............................................................ 18 23
4.2.1 Site of application and dosage form ...................................................................................18 24 4.3 INGREDIENTS .............................................................................................................................. 18 25
4.4 PRODUCT MAIN FUNCTION AND CLAIM ...................................................................................... 18 26
4.5 PRODUCT PRESENTATION .......................................................................................................... 19 27
5. MEDICAL DEVICE .................................................................................................................... 20 28
5.1. IN-VITRO DIAGNOSTIC MEDICAL DEVICES (IVDS): ................................................................. 20 29
5.2. LABORATORY PRODUCTS FOR NON-MEDICAL PURPOSES: ........................................................ 21 30
5.3 ACCESSORIES OF IVD MEDICAL DEVICES: ................................................................................ 22 31
5.4 CHEMICALS USED WITH/AS MEDICAL DEVICES: ........................................................................ 23 32
5.5 IN VITRO FERTILIZATION (IVF) AND ASSISTED REPRODUCTION TECHNOLOGIES (ART) 33 PRODUCTS: ............................................................................................................................................... 23 34
5.6 TOPICAL PRODUCTS: ................................................................................................................. 24 35
5.6.1 Wound Management products: ..........................................................................................24 36 EXAMPLES OF MEDICAL DEVICES: .......................................................................................................... 24 37
5.7 RADIATION EMITTING DEVICE/PRODUCTS: .............................................................................. 24 38
5.8 GENERAL HYGIENE PRODUCTS: ................................................................................................. 25 39
5.9 ASSISTIVE/SUPPORTIVE PRODUCTS: .......................................................................................... 25 40
5.10 DEVICES/PRODUCTS FOR PERSONAL PROTECTION: ....................................................................... 26 41
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5.11 GENERAL HEALTH PRODUCTS: .................................................................................................. 27 42
5.12 EDUCATIONAL AND RESEARCH USE ONLY (RUO) PRODUCTS/DEVICES: ................................ 27 43
5.12.1 Medical devices for research/educational use: ........................................................................27 44 5.12.2 Kits for research/educational use: ............................................................................................27 45 5.12.3 Devices labeled as for Research Use Only “RUO”: .................................................................28 46 5.12.4 Educational Devices: ................................................................................................................28 47 5.12.5 Demo Medical Devices: ............................................................................................................28 48
5.13 STERILIZATION AND DISINFECTION: ......................................................................................... 28 49
5.14 HEALTHCARE FACILITY PRODUCTS AND ADAPTATIONS: ......................................................... 29 50
5.15 DENTAL DEVICES: ...................................................................................................................... 30 51
5.16 COSMETIC DEVICES: .................................................................................................................. 32 52
5.17 OPHTHALMIC PRODUCTS: .......................................................................................................... 32 53
5.17.1 Sunglasses and spectacle frames: ......................................................................................32 54 5.17.2 Eye drops: ...........................................................................................................................33 55 5.17.3 Balanced Salt Solution(BSS) .............................................................................................33 56 5.17.4 Contact lenses and their care products: .............................................................................33 57
5.18 LUBRICANTS, MOISTURIZERS AND GELS ................................................................................... 33 58
5.18.1 Sexual Lubricant: ...............................................................................................................33 59 5.18.2 Coupling gel: ......................................................................................................................33 60 5.18.3 Body orifice gel:..................................................................................................................33 61
5.19 CONTRACEPTION DEVICES: ....................................................................................................... 34 62
5.20 DEVICES FOR BLOOD AND ORGAN PRODUCTS ........................................................................... 34 63
5.21 IRRIGATION SOLUTIONS: ........................................................................................................... 34 64
5.22 RAW MATERIALS AND COMPONENTS: ....................................................................................... 34 65
5.23 SPARE PARTS .............................................................................................................................. 34 66
67
68
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2. Introduction 69
1.1 Objectives 70
This guidance presents the Saudi Food and Drug Authority’s (SFDA)’s current view 71
on specific products or a category of products and whether it should be under the 72
responsibility of Saudi Food and Drug Authority and particularly where the regulation 73
may be on the borderline between two SFDA sectors. It is also intended to clarify the 74
type of information the SFDA recommends to be included in a request for 75
classification. However, this guidance is not all-inclusive and there may be some 76
products are still not included. Moreover, it does not provide any information about 77
risk classes of medical devices. 78
1.2 Background 79
The SFDA consists mainly of three sectors, Food, Drug and Medical Devices and 80
Products. Each sector is responsible for distinctive products with different regulatory 81
requirements. Therefore, the SFDA have been receiving a huge number of requests 82
from the industry since its establishment. Most are relating to whether a product should 83
be classified as a drug, a device or food. SFDA is also aware that other reasons behind 84
this practice include further identification of the subsequent scheme/path within each 85
sector. Therefore, this guidance document is created to help SFDA stakeholders as well 86
as SFDA staffs to classify products easily with a view to achieving greater consistency, 87
transparency and quality of classification decisions relating to these products. 88
1.3 scope 89
This guidance document pertains to a product or category of products that is under the 90
responsibility of each sector within SFDA. It also covers some other products which 91
are not regulated by the SFDA. 92
1.4 General Principles 93
SFDA will determine the classification of a product mainly on statutory definitions. Other 94
definitions included in the associated regulated guidelines will also be considered. For 95
example, a product may be classified as a device if it “does not achieve its primary intended 96
action in or on the human body by pharmacological, immunological or metabolic means. 97
If the product acts by such means, it will be classified as a drug. On the other hand, if the 98
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product contains a substance that has an ancillary action by assisting the product in 99
achieving its primary intended actions, the product may be classified as device. However, 100
this is not always the case. Some products come at the borderline between two definitions 101
(food/drug) or (drug/medical device). These products will be classified on a case-by-case 102
basis. 103
In achieving the final decision about classification of certain products, the SFDA will base 104
its judgment on the current scientific understanding of the product and its characteristics. 105
Moreover, the SFDA believes that global regulatory convergence is critical in achieving 106
cooperation among regulatory bodies. Therefore, the authority will make its best endeavor 107
in aligning its regulations with the common international practice and limit local 108
requirements to where genuinely required or scientifically justified to protect the public 109
health. 110
1.5 Definitions 111
Foodstuff: Any substance whether processed, semi-processed or unprocessed, which is 112
intended for direct human consumption or to be used in manufacturing, preparing or 113
treating a foodstuff. It does not include perfumes, tobacco and any other substances used 114
only as drugs. 115
Drug: An article intended for use in the diagnosis, cure mitigation, treatment, or 116
prevention of disease and which is intended to affect the structure or function of the body. 117
Medical device: ‘Medical device’ means any instrument, apparatus, implement, 118
machine, appliance, implant, in vitro reagent or calibrator, software, material or other 119
similar or related article: 120
A. Intended by the manufacturer to be used, alone or in combination, for human 121
beings for one or more of the specific purpose(s) of: 122
- Diagnosis, prevention, monitoring, treatment or alleviation of disease, 123
- Diagnosis, monitoring, treatment, alleviation of or compensation for 124
an injury or handicap, 125
8
- Investigation, replacement, modification, or support of the anatomy or 126
of a physiological process, 127
- Supporting or sustaining life, 128
- Control of conception, 129
- Disinfection of medical devices, 130
- Providing information for medical or diagnostic purposes by means of 131
in vitro examination of specimens derived from the human body; 132
and 133
B. Which does not achieve its primary intended action in or on the human body 134
by pharmacological, immunological or metabolic means, but which may be 135
assisted in its intended function by such means. 136
“Pharmacological means”, in the context of the MDD and AIMD, is understood as an 137
interaction between the molecules of the substance in question and a cellular constituent, 138
usually referred to as a receptor, which either results in a direct response, or which blocks 139
the response to another agent. Although not a completely reliable criterion, the presence of 140
a dose-response correlation is indicative of a pharmacological effect. 141
“Immunological means”, is action in or on the body by stimulation and/or mobilisation 142
of cells and/or products involved in a specific immune reaction. 143
“Metabolic means”, is an action which involves an alteration, including stopping, starting 144
or changing the speed of the normal chemical processes participating in, and available for, 145
normal body function. 146
147
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2 Food 148
The product would be considered as a food when it falls under the following categories: 149
2.1. Meat and meat products. 150
2.2. Fish and Shell-Fish Products 151
2.3. Milk and dairy products. 152
2.4. Processed fruits and vegetables products. 153
2.5. Cereals, Pulses and Nuts and Their Products. 154
2.6. Vegetable fats, Oils and Their Products 155
2.7. Water and Beverages which do not contain ingredients with medicinal effect. 156
2.8. Honey and foods which contain bee products such as royal jelly, bee pollen and 157
propolis. 158
2.9. Energy drinks 159
2.10. Food additives that are intended for food industrial uses. 160
2.11. Food sweeteners. 161
2.12. Infant and baby foods. 162
2.13. Foods for special medical purposes 163
2.14. Proteins, Carbohydrates and Amino acids products that are used as food supplement, 164
with exception of amino acids and protein products in pharmaceutical form. 165
2.15. Vitamins and minerals supplements that contain 100% or less of NRVs values 166
(according to GSO 2233 “Requirements of nutritional labeling”) with exception of 167
supplements marketed in pharmaceutical forms. 168
2.16. Lozenges, which do not contain unacceptable claim or any ingredient with medicinal 169
effect, and the concentration of Menthol, is less than 5 mg. 170
2.17. Collagen products that may contain vitamins and minerals 100% or less of NRVs 171
values (according to GSO 2233 “Requirements of nutritional labeling”) with 172
exception of products marketed in pharmaceutical forms. 173
2.18. Food products which contain Moringa leaves with exception of products marketed 174
in pharmaceutical forms. 175
2.19. Novel foods, which do not contain ingredients with medicinal effect. 176
2.20. Prebiotic and Probiotic that are intended for food industrial uses. 177
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2.21. Food products which contain fish oil. 178
2.22. Fibers products with exception of products marketed in pharmaceutical forms. 179
2.23. Sport Drinks. 180
2.24. Weight management products with exception of products marketed in 181
pharmaceutical forms. 182
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3 Drug 183
A "drug product" means a substance or a combination of substances which may be used in 184
or administered to human or animal beings either with a view to restoring, correcting or 185
modifying physiological functions by exerting a pharmacological, immunological or 186
metabolic action or to making a medical diagnosis;’ 187
3.1.Human Drug 188
A product would be considered as a drug if it falls within the above-mentioned 189
definition. The definition is including the following products: 190
1. One or more vitamins and/or minerals with concentrations above the upper 191
concentration limit of vitamins and minerals. The upper and lower 192
concentrations limits will be calculated according to the product total daily 193
dose. (Appendix 2) 194
2. Products contain any of the following substances: 195
Salicylic acid in concentration More than 2%* (please see cosmetic 196
classification section for cosmetics containing this ingredient). 197
Hydroquinone. 198
Ichthammol and coal tar 199
Tretinoin (Retinoic acid) and its salts. 200
Glucosamine. 201
3. Medicated eye drops 202
4. Saline and sterile water that are intended for intravenous 203
5. Parenteral nutrition solution 204
6. injectable medicines dosage form 205
7. Peritoneal dialysis solution 206
8. Blood derivative products 207
9. Enema solutions products (rectal solution products) 208
10. An allergen tests are used internally and indicated in the diagnosis of 209
specific allergies.an allergen, except an allergen for skin patch testing on 210
unbroken skin. 211
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11. Therapeutic Radiopharmaceuticals 212
12. Medical gases (oxygen ، Nitrogen ، Nitrous oxide ،Carbon dioxide ، Helium 213
، Medical air & Carbon monoxide). 214
13. Vaccines 215
14. biotechnology medicines 216
15. Immunoglobulins. 217
16. Antiseptic products for human use, for example: 218
Benzalkonium 219
Benzethonium 220
Chlorhexidine 221
Chloroxylenol 222
Methylbenzethonium 223
Povidone-iodine 224
Hydrogen peroxide (H2O2) 225
Triclocarban 226
Triclosan 227
228
229
230
231
232
17. Medicated throat lozenges like resorcinol, Cetylpyridinium and Benzyl 233
Alcohol. 234
18. Anti-lice products containing non-listable ingredients such as malathion, 235
permethrin, and pyrethrins. 236
3.2.Herbal and Health products 237
3.2.1. Herbal product 238
A product would be considered as a medicinal herbal product when it falls within the 239
following definition: Finished, labeled products in pharmaceutical dosage forms that 240
Note:
Products used for cosmetic purposes and contain one of the above
ingredients within the concentrations recommended by the GSO
standards for cosmetic products will be classified as cosmetic.
13
contain one or more of the following: powdered plant materials, extracts, purified extracts, 241
or partially purified active substances isolated from plant materials. 242
The number of herbs in the oral dosage form products should not exceed 243
five herbs. 244
Homoeopathic preparations are not allowed to be marketed in Saudi 245
Arabia due to the lack of supporting evidence of its safety and efficacy 246
247
3.2.2. Health product: 248
1. A product would be considered as a health product subject for registration 249
when it falls within the following definition: Finished, labeled product in 250
pharmaceutical dosage form which may contain one or more of the 251
following ingredients : 252
2. Amino acid 253
3. Charcoal. 254
4. microorganism whole or extracted except a vaccine and antibiotics eg 255
Probiotics. 256
5. One or more vitamins and/or minerals with concentrations equal or below 257
the upper concentration limit provided that none of these vitamins and/or 258
minerals are below the lower concentration limit. The upper and lower 259
concentrations limits will be calculated according to the product total daily 260
dose. (Appendix 2) 261
6. A lipid, including an essential fatty acid or phospholipids e.g. omega 3. 262
7. Throat lozenges which consist only of volatile oils, ascorbic acid (or its 263
salts) and at least menthol with no unacceptable claim. The concentration 264
of the individual ingredients (menthol, eucalyptus oil and Ascorbic acid) 265
must not exceed the maximum value as follows: 266
Menthol 5 - 20 mg 267
Eucalyptus oil 0.2 - 15 mg. 268
Ascorbic acid: 100 mg 269
8. Natural enzyme products. 270
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9. Electrolyte products other than those used as fluid replacement for athletes. 271
10. Anti-lice products containing natural source oils or ingredients 272
11. Topical patches, creams, ointments and gels containing counter irritant 273
ingredient as an externally applied substance that causes irritation or mild 274
inflammation of the skin for the temporary relieve of pain in muscles or 275
joints by reducing inflammation in deeper adjacent structures (these 276
products should comply with the Canadian Counterirritant monograph ( 277
Appendix 3). 278
12. Alcohol hand sanitizersincluded this ingredient and concentration (Ethanol 279
60-80% & Isopropanol 60-70%). 280
Topical products containing organic acids (Alpha-hydroxy acids (AHAs)) in total 281
concentration of organic acids more than 10% . 282
283
3.3.Veterinary Drugs 284
3.3.1. Veterinary Medicinal Product 285
When a substance, part of a substance or a combination of substances associated with a 286
therapeutic (medicinal) property or pharmacological effect. 287
3.3.2. Insecticides 288
Veterinary products, which contain substances that kill insects or external parasites, such 289
as pyrethrins, pyrethroids or organophosphate compounds. 290
3.3.3. Shampoos 291
A shampoo for animals will be considered medicinal if it contains an insecticide or an 292
ingredient, which has a pharmacological effect or is presented as an insecticidal shampoo. 293
3.3.4. Teat and Udder Products 294
Products applied internally to teats and udders for the prevention of mastitis. 295
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3.3.5. Herbal Products 296
Herbal products require a market authorization if they are medicinal by presentation or 297
function. For example, a product containing pyrethrum, pyrethrins or alkaloids, such as 298
digoxin from Digitalis sp., would be considered medicinal by function. 299
3.3.6. Diagnostic Tools (Testing Kits) 300
Any substance, or combination of substances administered to animals with a view to 301
making a medical diagnosis. 302
303
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4 Cosmetic Products 304
The product will be classified as a cosmetic product if compatible with the 305
following definition: 306
Any substance or mixture intended to be placed in contact with the external parts 307
of the human body (epidermis, hair system, nails, lips and external genital organs) 308
or with the teeth and the mucous membranes of the oral cavity with a view 309
exclusively or mainly to cleaning them, perfuming them, changing their 310
appearance, protecting them, keeping them in good condition or correcting body 311
odors. 312
The following list is a main category of cosmetic products with examples (but 313
non-exclusive): 314
4.1 Skin Products 315
4.1.1 Skin care Products 316
Face care products other than face mask, Face mask, Eye contour products, Lip 317
care products, Hand care products, Foot care products, Body care products, 318
External intimate care products, Chemical exfoliation products, Mechanical 319
exfoliation products, Skin lightening products, Other skin care products. 320
4.1.2 Skin cleansing products 321
Soap products, Bath / shower products, Make-up remover products, External 322
Intimate hygiene products, Other skin cleansing products 323
4.1.3 Body hair removal product 324
Chemical depilatories, Physical epilation products, Other body hair removal 325
products 326
4.1.4 Bleach for body hair products 327
4.1.5 Correction of body odour and/or perspiration 328
Products with antiperspirant activity, Products without antiperspirant activity 329
4.1.6 Shaving and pre- / after- shaving products 330
4.1.7 Make-up products 331
Foundation, Concealer, Other face make-up products, Mascara, Eye shadow, Eye 332
pencil, Eye liner, Other eye make-up products, Lip stick, Lipstick sealer, Other lip 333
17
make-up products, Body or face paint , including "carneval make-up", Other 334
make-up products 335
4.1.8 Perfumes: 336
Hydroalcoholic perfumes, Non hydroalcoholic perfumes 337
4.1.9 Sun and self-tanning products 338
Before and after sun products, Sun protection products, Self-tanning products, 339
Other sun and self-tanning products 340
4.1.10 Other skin products: 341
A. Hair and Scalp Products 342
Hair and scalp care and cleansing products 343
Shampoo, Hair conditioner, Scalp and hair roots care products, 344
Antidandruff products, Antihairloss products, Other hair and scalp care 345
and cleansing products 346
Hair colouring products 347
Oxidative hair colour products, Non-oxidative hair colour products, 348
Hair bleaching and dye remover products, Other hair colouring 349
products. 350
Hair styling products 351
Products for temporary hair styling, Permanent wave products, Hair 352
relaxer / straightener products, other hair styling products 353
Other hair and scalp products 354
Hair sun protection products, Other hair and scalp products 355
B. Nail and cuticle products 356
Nail varnish and remover products 357
Nail varnish / Nail make-up, Nail varnish remover, Nail varnish 358
thinner, Nail bleach, Other nail varnish and remover products 359
Nail care / nail hardener products 360
Nail care products, Nail hardener, Other nail care / nail hardener 361
products 362
Nail glue remover products 363
Other nail and cuticle products 364
18
Cuticle remover / softener, Nail sculpting products, Other nail and 365
cuticle products 366
C. Oral hygiene products 367
Tooth care products 368
Toothpaste, Tooth cleansing powder / salt, Other tooth care products 369
Mouth wash / breath spray 370
Mouth wash, Breath spray, Other mouth wash / breath spray products 371
Tooth whiteners 372
Other oral hygiene products 373
4.2 Classification criteria of Cosmetic products: 374
4.2.1 Site of application and dosage form 375
The products should be intended to be placed in contact with the external parts of 376
the human body (epidermis, hair system, nails, lips and external genital organs) or 377
with the teeth and the mucous membranes of the oral cavity. Products that are 378
intended for (internal use) cannot be considered to be cosmetic products, e.g.: 379
Products that are taken orally (syrup, solution, drink, capsules, 380
tablet…etc). 381
Products that are taken through the eyes or nose or ear (drops, 382
sprayer...etc). 383
Products intended for injection (IV, IM, IS…etc). 384
Products that are taken through the anal or vagina (Enema, supposotiry, 385
solution, tab, capsules… etc). 386
4.3 Ingredients 387
Cosmetic products should not contain any medical or therapeutic substances. 388
Also, the cosmetic products must comply with the COSMETIC PRODUCTS 389
SAFETY REQUIREMENTS GSO 1943 and circulars issued by SFDA. 390
4.4 Product main function and claim 391
The product should be applied to the external parts of human body with a view 392
exclusively or mainly to cleaning them, perfuming them, changing their 393
19
appearance, protecting them, keeping them in good condition or correcting body 394
odors. 395
Cosmetic products should not contain medical or therapeutic claims, and they 396
should not have a significant physiological effect. 397
4.5 Product presentation 398
The product should not be presented as treating or preventing disease in human 399
beings. The following features of the product should be taken into account: 400
Product claims and the context in which the claims are made 401
Labeling and packaging/packaging inserts (including graphics) 402
Promotional literature, including testimonials and literature issued by third 403
parties on behalf of the supplier. 404
Advertisements 405
The product form and the way it is to be used e.g. capsule, tablet, injection 406
etc. 407
Particular target of the marketing information e.g. specific population groups 408
with, or particularly vulnerable to, specific diseases of adverse conditions. 409
Note: 410
All cosmetic products must comply with the following: 411
Safety Requirements of Cosmetics and Personal Care Products GSO1943, 412
in addition to the specific product standard (if any), which can be obtained 413
through the GSO website: www.GSO.org.sa 414
Circulars issued by SFDA 415
Any other technical requirements specified by the SFDA 416
417
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5. Medical device 418
The medical device definition states that Medical device “means any instrument, 419
apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, 420
software, material or other similar or related article . . .”. The SFDA’s interpretation is 421
that “similar or related article” under this definition should mean any article in any form. 422
However, “similar or related articles” may be classified as devices as long as they also 423
meet the conditions stipulated in point A and B of the medical device definition. 424
5.1.In-Vitro Diagnostic medical devices (IVDs): 425
“means a medical device, whether used alone or in combination, intended by the 426
manufacturer for the in-vitro examination of specimens derived from the human body 427
solely or principally to provide information for diagnostic, monitoring or compatibility 428
purposes” 429
Examples: 430
ABO Blood grouping 431
Blood glucose meters and strips. 432
Blood collection tubes, urine sample containers are considered as IVDs. 433
General-purpose laboratory equipment labeled or promoted for a specific 434
medical use. 435
Densitometry analyser IVD. 436
Self-pregnancy test. 437
The calibrators and control materials used to verify the performance of the 438
analyzers. 439
Swabs. 440
441
Note 1: 442
If the specimen is not derived from the human body or if the procedure takes 443
place in or on the human body (in vivo), the devices are considered Medical 444
Devices. 445
Example: 446
A pulse oximeter. 447
21
Body composition analyzer. 448
449
Note 2: 450
A Helicobacter pylori breath test kit containing labelled urea is a combination 451
products containing two parts: 452
Urea is considered a medicinal substance. 453
A sample container is considered an IVD. 454
5.2. Laboratory products for non-medical purposes: 455
a. Products for General Laboratory Use (GLU) are not considered in vitro diagnostic 456
medical devices unless such products are intended for clinical diagnostic purposes. 457
the labeling must indicate that the device is For General laboratory Use and Not for 458
use in diagnostic procedures. 459
Example: 460
Centrifuge 461
Scales 462
balances 463
Incubators 464
Drying oven. 465
Autoclave for laboratory use. 466
Multipurpose tubes. 467
Pipettes. 468
Mixers. 469
Shakers. 470
Products to transfer sample which does not come into direct contact with 471
the human body such as plastic pipettes to transfer blood drop from finger 472
to rapid test. 473
Note: 474
GLU should not be used for medical purposes. For example, GLU 475
incubators is not intended to cultivate microorganisms and for the purpose 476
of diagnosis of disease 477
22
b. Devices for detection, reading of non-clinical samples, e.g. pathological agents in 478
the environment, are not IVDs neither general laboratory use. Therefore, they are 479
not regulated by the SFDA. 480
c. Devices for detection of agents of biological or chemical warfare in the 481
environment are not IVD because they do not have a medical purpose. 482
d. Devices for non-medical purposes, even if these devices are used for in-vitro 483
examination of specimens derived from the human body, for example paternity 484
tests or tests for detecting drugs of abuse/alcohol, are not IVD’s. therefore, they are 485
not regulated by the SFDA 486
487
e. All kits such as reagents, standards, calibrators indicators …etc, which are used 488
for non-clinical / non-medical purposes are not considered IVD medical devices. 489
However, these kits must obtain a Medical Device Importation License (MDIL) 490
as non-medical IVD 491
Examples: 492
Reagents used for food and water testing. 493
Limulus Amebocyte Lysate (LAL) tests for the detection of for 494
endotoxins in injectable pharmaceuticals, biological products and 495
medical devices. 496
5.3 Accessories of IVD medical devices: 497
The accessories are treated like IVDs in terms of the applicable regulations. They are 498
intended specifically by their manufacturer to: 499
be used together with an IVD medical device to enable that device to be 500
used in accordance with its intended use as an IVD medical device. 501
or to augment or extend the capabilities of that device in fulfilment of its 502
intended use as an IVD medical device. 503
Examples: 504
A cleaning solution specifically intended by its manufacturer to be used 505
with a defined automated IVD instrument. 506
Bar code scanners. 507
General media such as saline for running instruments. 508
23
5.4 Chemicals used with/as medical devices: 509
Some chemical substances and mixtures which are used in its final form in some medical 510
device application require Medical Device Importation License. 511
Example: 512
Chemical substances and mixtures used in fabrication of prosthesis. 513
Calibration gases and chemicals for medical devices. 514
Chemical substances and mixtures used to sterilize medical devices. 515
Note: 516
Chemicals which fall into the above category must obtain a Medical Device 517
Importation License. However, if the definition of a medical device or an accessory 518
applies, the product must comply with the relevant Medical Device Interim 519
regulations. 520
5.5In Vitro Fertilization (IVF) and Assisted Reproduction Technologies (ART) 521
products: 522
Because IVF procedure and product is intended to modify and support a physiological 523
process, they are considered medical devices under the Medical Device Interim Regulation. 524
Examples of products, which could be qualified as medical devices: 525
IVF workstations. 526
Pipettes or syringes 527
Washing, separating, sperm immobilizing, cryoprotecting solutions. 528
Devices manufactured utilizing animal tissues or derivatives rendered non-529
viable 530
Devices incorporating, as an integral part, a human blood derivative or a 531
medicinal product is liable to act on the human body with action ancillary 532
to that of the devices. 533
Media intended for use in the IVF process to support the growth storage of 534
the embryo. 535
24
5.6 Topical Products: 536
5.6.1 Wound Management products: 537
If a wound management product acts physically and does not achieve its primary 538
intended action in or on the human body by pharmacological, immunological or 539
metabolic means, it is considered a Medical Device. 540
Examples of medical devices: 541
Non-medicated dressing used as a physical barrier, for compression or for 542
absorption of exudates such as Hydrogel dressings and Alginate dressing. 543
Devices principally intended to manage the micro-environment of a wound 544
such as honey wound dressing gel. 545
Wound dressing with antimicrobial substance such as silver to protect the 546
dressing and reduce odour. 547
Absorbable hemostatic dressings. 548
silicone sheets or gel for scars. 549
550
5.7 Radiation Emitting Device/products: 551
Any device or component of device or accessory to a device, which produces and emits 552
radiation for the purpose of diagnosis, treatment or alleviation of disease, an injury is 553
considered a medical device. 554
Examples: 555
Imaging Products (X-ray, CT, MRI, US, Nuclear imaging products). 556
Diagnostic Radioactive materials. 557
Digital imaging/x-ray film cassette. 558
Note: 559
In-vivo dosimeter to record dose received by a patient during a radiotherapy 560
procedure is a medical device. 561
25
5.8 General hygiene products: 562
General hygiene products are not considered medical devices, as the medical definition 563
does not apply. Moreover, some of these products may achieve its intended purpose 564
through chemical action on the human body. 565
Examples of non-medical devices: 566
Baby nappies. 567
Teats ( regulated by food sector) 568
Feminine hygiene products (sanitary pads) 569
General hand cleansing wipes. 570
General use disinfectants / cleaners for environment, rooms, surfaces. 571
Dental disclosing solution/tablets. 572
Insect repellent. 573
574
However, similar products may be regulated as medical devices, if there is a 575
specific medical purpose. 576
Examples of medical device: 577
Sanitary pads claiming pain relief by physical means. 578
Nibble shields to protect or relieve sore, damaged or cracked nipples or to 579
be which is used to cover and protect the nipple of a nursing mother. 580
Electrical and manual Breast pumps 581
Surgical Razors and clippers 582
Reusable/ single use Patient Bedding set. 583
General disinfectants claiming prevention of disease. 584
Sitz bath. 585
5.9 Assistive/supportive products: 586
Assistive and products/devices are regulated as medical devices if they are intended for 587
alleviation of or compensation for an injury or handicap or support of the anatomy of 588
human beings. 589
Examples of medical device: 590
Wheelchairs. 591
26
Patients beds. 592
Hearing aids 593
Walking crutches. 594
Patient hoists. 595
Commode chairs. 596
Abdominal/breast/perineal binders. 597
Orthoses. 598
However, products for daily use by everyone are not be considered as medical 599
device 600
Examples of non-medical devices: 601
Portable ramps 602
5.10 devices/products for Personal protection: 603
If the product is used in a medical field such as operating room with a view to protect the 604
health and safety of the patient, it is considered a medical device. where a product is 605
intended to protect the user then it falls outside the scope of medical device interim 606
regulation. 607
Examples non-medical device: 608
Medical laboratory protective gloves 609
Dust Mask. 610
Gum shields for boxers. 611
Air Purifying Dust/Particulate Respirators. 612
These types of products should not contain any claims related to prevention of disease. 613
However, if such claims are present or implied, the product is considered to be medical 614
device. 615
Examples for medical devices: 616
Surgical and examination gloves 617
Surgical and examination Face masks. 618
Apron. 619
Sharps containers. 620
27
Surgical apparel which includes examples includes surgical caps, hoods, 621
masks, gowns, drapes, operating room shoes and shoe covers, and isolation 622
masks and gowns.. 623
5.11General health products: 624
Products for sport or leisure purposes which are used to maintain a healthy status are not 625
considered to be medical devices unless there is intended medical purpose like treatment 626
or diagnosis of pain or injury. 627
Examples for sport products that are not considered medical devices: 628
Fitness equipment in general. 629
Manual massager with no medical purposes. 630
Watches/activity trackers with/without a heart rate monitor. 631
Examples of medical devices: 632
Heat/cold pads for pain relief. 633
Bandages. 634
Electrical nerve stimulator for pain relief. 635
Body Composition analyzer. 636
Heating and chilling units for packs. 637
devices for rehabilitation. 638
Note: 639
Blood pressure monitors are considered to be medical devices regardless of where 640
they are used. 641
5.12 Educational and Research Use Only (RUO) products/devices: 642
5.12.1 Medical devices for research/educational use: 643
Medical Products/devices which fall into this category must obtain a Medical Device 644
Importation License which are based on a purchasing order and a attestation letter from 645
the end user. 646
5.12.2 Kits for research/educational use: 647
Kits which fall into this category must obtain a Medical Device Importation License. 648
28
5.12.3 Devices labeled as for Research Use Only “RUO”: 649
RUO devices must have no intended medical purposes and be labeled “For research Use 650
Only” to avoid their potential misuse by institutions or laboratories. Such devices are not 651
considered Medical Devices. However, they must obtain a Medical Device Importation 652
License. This type of product may target the local market and a purchasing order and an 653
attestation letter from a buyer is not required. 654
Examples: 655
RUO products used for Basic Research in research centers. 656
RUO products used in Pharmaceutical Research. 657
Note: 658
All RUO products/devices must obtain a Medical Device Importation License 659
(MDIL). 660
5.12.4 Educational Devices: 661
Devices for educational and training purposes are not regulated as medical devices: 662
Examples: 663
Mock-ups. 664
Patient simulators. 665
5.12.5 Demo Medical Devices: 666
If a device is intended for presentation or demonstration proposes, it must be labeled “for 667
presentation or demonstration purposes only”. Medical Device Importation License is 668
required for this type of devices. 669
5.13Sterilization and disinfection: 670
Classification of disinfectants is based on the intended purpose of the product. Any article 671
intended to be used for disinfection of medical devices is considered to be a medical device. 672
Therefore, manufacturers should avoid using “disinfection of medical devices” on the 673
labeling of its products if they are not intended for this purpose. 674
A disinfectant is not considered an accessory to the medical device because it is explicitly 675
stated in the definition and, therefore, is a standalone medical device. However, a 676
disinfectant that is specifically intended for the disinfection of a specific medical device is 677
considered an accessory to this device. 678
29
Example medical devices: 679
Ethylene oxide sterilizer 680
Detergents for sterilization of medical devices. 681
Disinfectants for dental water line and the fluid pathways of haemodialysis 682
machine 683
Denture disinfecting products. 684
Medical Washers 685
Note1: 686
A pre-sterilization device to clean instruments before being sterilized is 687
considered a medical device. For example, Ultrasonic cleaning unit. 688
Note2: 689
Accessories of medical device disinfectants falls under the scope of Medical Device 690
interim regulations 691
Examples of sterilization accessories: 692
Sterilization packaging. 693
Physical/chemical/enzymatic Sterilization process indicator. 694
Instrument tray 695
However, general disinfectants intended for general use for rooms, hard 696
surfaces are not considered medical devices. Claims corresponding to these 697
devices should be clearly distinguished from those for a medical device 698
status. 699
5.14 Healthcare facility products and adaptations: 700
Not all devices/ equipment, which are used in the health care facility, are medical devices. 701
As these devices do not meet the medical device definition. 702
Examples of non- medical devices: 703
Medical gas pipeline system. 704
Medication refrigerators. 705
Bedside cabinets. 706
Overbred tables. 707
Trolleys for general use (Crash/Emergency trolley is a medical device). 708
30
Mayo Stand. 709
Air purifiers / Air decontamination units / Mobile air decontamination units. 710
Gallipots. 711
Drug storage cabinet. 712
Dressing trolleys. 713
Hospital linen hampers 714
Mortuary fridge 715
However, some devices are considered medical 716
Example of medical devices: 717
Examination/treatment chair. 718
Surgical lights as these devices are used to effectively illuminate the field 719
or the patient. 720
Patients beds. 721
722
5.15Dental devices: 723
Dental Products, which are used on the patient, are highly likely to be considered Medical 724
Devices. 725
Examples: 726
Manual and Powered toothbrush. 727
Dental impression materials and trays. 728
Dental impression material mixer/syringe. 729
Restorations and base metal alloys. 730
Implant analog system. 731
Amalgamator. 732
Articulator. 733
Hand held mirror. 734
Polishing and cleaning agent which are use professionally. 735
Etching gel. 736
Dentistry products with aluminum chloride used in hemostasis. 737
31
A 5% sodium fluoride desensitizing agent which is administered by a dental 738
professional. 739
Saliva absorber. 740
Example of non-medical products: 741
Dental casting furnace. 742
Dental laboratory drilling system handpiece/motor. 743
dental laboratory burs. 744
32
5.16Cosmetic devices: 745
There are some cosmetic devices which fall under the scope of the Medical Device 746
Interim Regulation (MDIR) . Article 3.C of MDIR states that “contact lenses and laser 747
surgical equipment for cosmetic purposes and their accessories” are regulated by the 748
SFDA. 749
However, some cosmetic devices fall under the definition of a medical device. These 750
devices may replace, modify or support the anatomy or a physiological process in or on 751
the human body. For examples: 752
Laser/Intense Pulse Light (IPL)Hair removal devices. 753
Artificial light tanning devices. 754
Disincrusting device for cleaning with an intensity not exceeding 4 mA. 755
Intense Pulse Light( IPL) for hair removal. 756
Tanning solariums with ultraviolet UV lamps or combined or separate (UV) 757
and infrared (IR) applications 758
Defocused aesthetic lasers for epilation. 759
Electrical epilators using needles, tweezers or equivalent accessories or light 760
pulses for photo-epilation. 761
Ultrasound stimulators and micro-current stimulators. 762
Partial or total heat treatment appliances using resistive or capacitive 763
radiofrequency. 764
Pulsed electrostimulator. 765
Skin tightening by laser or photon light. 766
LED Light therapy and rejuvenation for skin. 767
Microdermabrasion Machine. 768
5.17Ophthalmic products: 769
5.17.1 Sunglasses and spectacle frames: 770
Spectacle lenses which are used to attenuate rays of light by absorption, reflection, or 771
polarization to protect the eyes from light are considered medical devices. 772
33
5.17.2 Eye drops: 773
Eye drops intended for the alleviation dryness or discomfort caused by environmental 774
factors are considered medicinal products and regulated by the Drug Sector. 775
5.17.3 Balanced Salt Solution(BSS) 776
BSS intended for eye irrigation during surgical procedure is considered a medical device. 777
see 5.21. 778
5.17.4 Contact lenses and their care products: 779
Non-corrective lenses, coloured or not are considered to be medical devices on the basis 780
that they prevent, treat or alleviate disease. 781
Examples: 782
UV blocking contact lenses to alleviate photophobia. 783
Contact lenses for therapeutic use as a bandage. 784
Note: 785
contact lenses for cosmetic purposes which have no medical claims must 786
comply with the Medical Device Interim regulation. See 5.16 787
Products specifically intended to be used for disinfecting, cleaning, rinsing 788
or, hydrating contact lenses are medical devices. 789
5.18 Lubricants, moisturizers and Gels 790
5.18.1 Sexual Lubricant: 791
A non-medicated substance intended to be applied to the penis and vagina for lubrication 792
during sexual intercourse. It is considered a medical device. 793
5.18.2 Coupling gel: 794
A medium designed to be applied between an analytical device (e.g., ultrasound 795
transducer) and the patient, allowing signals to pass through the skin during an 796
examination. This type of products is considered a medical device 797
5.18.3 Body orifice gel: 798
A substance intended to facilitate entry of a device into a body orifice in the body 799
whether it is a natural opening or any permanent artificial opening. It is considered a 800
Medical Device. 801
34
5.19 Contraception devices: 802
a contraceptive product which acts as by physical means and is intended to control birth is 803
considered a medical device. 804
Examples: 805
Condoms with/without spermicide. 806
Condom with desensitizing agent such as benzocaine. 807
Contraceptive diaphragms 808
Intrauterine device IUD /with Copper 809
However, if a product has pharmacological, metabolic or immunological actions. Then, the 810
product is considered medicinal product. 811
Example of medicinal products: 812
Intrauterine device with progestin. 813
5.20 Devices for blood and organ products 814
Blood bags (including those containing or coated with an anticoagulant) are 815
considered to be medical device. 816
Kidney donor-organ preservation/transport perfusion set is considered a medical 817
device. 818
5.21 Irrigation solutions: 819
Irrigation solutions intended for mechanical rinsing are considered to be medical devices 820
unless such solutions contain ingredients that have an antimicrobial action on the body 821
such as chlorhexidine and iodine. In this case, such products are regulated by the drug 822
sector. 823
5.22 Raw materials and components: 824
Raw materials, component parts or semi-finished products that requires further 825
manufacturing process are not normally considered medical devices. . 826
5.23 Spare parts 827
Medical device spare parts which are supplied for the replacement of existing components 828
of a medical device that has already obtained a medical device marketing authorization or 829
listed in the medical device national registry are not considered medical devices as long 830
as they do not significantly impact the performance and safety of a medical device.. 831
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