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Dr. V.G. SOMANI
Drugs Controller General
(India), CDSCO
Ministry of Health & Family
Welfare,
Government of India
Update on Medical
Device and IVD
Regulation in India
Contents
Medical Device Rules- 2017
Salient Points in MDR-2017
Achievements of Ministry of Health & Family Welfare ,
Govt. of India in the field of regulations
Roadmap of medical devices
Medical Device Rules,2017
MOH&FW, Government of India has notified the Medical Devices Rules 2017
vide G.S.R. 78(E) dated 31.01.2017 under the provisions of the Drugs and
Cosmetics Act, 1940.
Said rules are effective from 01.01.2018 to regulate the Clinical Investigation,
Manufacture, Import, Sale and Distribution of the medical devices in the
country.
The Medical Devices Rules, 2017 are harmonised with the international
regulatory practices and provide comprehensive legislation for the regulation
of Medical Devices.
Scope of the regulation
Medical Device Rules,2017 shall be applicable to:
(i) substances used for in vitro diagnosis and surgical dressings, surgical bandages, surgical
staples, surgical sutures, ligatures, blood and blood component collection bag with or
without anticoagulant covered under sub-clause (i) of section 3 of the Drugs and
Cosmetics Act, 1940 (23 of 1940);
(ii) substances including mechanical contraceptives (condoms, intrauterine devices, tubal
rings), disinfectants are notified under sub-clause (ii) of section 3 of the Drugs and
Cosmetics Act, 1940 (23 of 1940); and
(iii) devices notified from time to time under sub-clause (iv),
of clause (b) of section 3 of the Drugs and Cosmetics Act, 1940 (23 of 1940);
5
The Govt of India has notified…S No. Name of the device Notification Number Date of notification
1 Disposable Hypodermic Syringes GSR 365 (E) 17-03-1989
2 Disposable Hypodermic Needles GSR 365 (E) 17-03-1989
3 Disposable Perfusion Sets GSR 365 (E) 17-03-1989
4 In vitro Diagnostic Devices for HIV, HbsAg, HCV GSR 601(E) 27-08-2002
5 Cardiac Stents S.O. 1468 (E) 06-10-2005
6 Drug Eluting Stents S.O. 1468 (E) 06-10-2005
7 Catheters S.O. 1468 (E) 06-10-2005
8 Intra Ocular Lenses S.O. 1468 (E) 06-10-2005
9 I.V. Cannulae S.O. 1468 (E) 06-10-2005
10 Bone Cements S.O. 1468 (E) 06-10-2005
11 Heart Valves S.O. 1468 (E) 06-10-2005
12 Scalp Vein Set S.O. 1468 (E) 06-10-2005
13 Orthopedic Implants S.O. 1468 (E) 06-10-2005
14 Internal Prosthetic Replacements S.O. 1468 (E) 06-10-2005
15 Ablation Devices S.O.237(E) 25.01.2016
Cont..The Products which were already regulated as ‘drugs’ but now fall
under the scope of Medical Devices Rules, 2017:-
16. Blood Grouping Sera
17. Ligatures, Sutures and Staplers
18. Intra Uterine Devices (Cu-T)
19. Condoms
20. Tubal Rings
21. Surgical Dressings
22. Umbilical tapes
23. Blood/Blood Component Bags
24. Disinfectant
7
Newly notified medical deviceS No. Name of the device Effective
from
Notification Number Date of notification
25 Nebulizer 01.01.2021 S.O. 5980(E)/4671 (E) 03.12.2018/27.12.2019
26 Blood Pressure Monitoring Device 01.01.2021 S.O. 5980(E)/4671 (E) 03.12.2018/27.12.2019
27 Glucometer 01.01.2021 S.O. 5980(E)/4671 (E) 03.12.2018/27.12.2019
28 Digital Thermometer 01.01.2021 S.O. 5980(E)/4671 (E) 03.12.2018/27.12.2019
29 Organ Preservative Solution 02.04.2019 S.O. 1500(E) 02.04.2019
30All implantable medical devices Equipment
01.04.2021 S.O. 775 (E)/4672 (E) 08.02.2019/27.12.2019
31 CT Scan Equipment 01.04.2021 S.O. 775 (E)/4672 (E) 08.02.2019/27.12.2019
32 MRI Equipment 01.04.2021 S.O. 775 (E)/4672 (E) 08.02.2019/27.12.2019
33 Defibrillators 01.04.2021 S.O. 775 (E)/4672 (E) 08.02.2019/27.12.2019
34 PET Equipment 01.04.2021 S.O. 775 (E)/4672 (E) 08.02.2019/27.12.2019
35 X-Ray Machine 01.04.2021 S.O. 775 (E)/4672 (E) 08.02.2019/27.12.2019
36 Dialysis Machine 01.04.2021 S.O. 775 (E)/4672 (E) 08.02.2019/27.12.2019
37 Bone marrow cell separator 01.04.2021 S.O. 775 (E)/4672 (E) 08.02.2019/27.12.2019
38 Ultrasound 01.11.2020 S.O. 3721 (E) 16.10.2019
Chapter- I Title, Application, Commencement, Definition
Chapter - II Classification of MD, Grouping of MD, Essentials Principles
Chapter - III Authorities, delegation of powers, Notified bodies, Medical Devices Testing Centres,
Chapter - IV Manufacture of MD-Application, Inspection, grant of lic, conditions of lic, Suspension, Cancellation,
Appeal, Test License
Chapter - V Import of MD-Application, Overseas Inspection, grant of lic, Test lic, Hospital use, Personal use
Chapter - VI Labelling requirement
Chapter - VII Clinical Investigation- Permission, Medical management, Compensation, Inspection
Chapter - VIII Permission to import or manufacture medical device which does not have predicate medical device
Chapter -IX Duties and Powers of Medical Device Officer, Medical Device Testing Officer and Notified Body
Chapter -X Regulation of Laboratories for carrying test or evaluation
Chapter - XI Sale of Medical Devices
Chapter - XII Miscellaneous – Rejection of application, Debarment of applicant, Exemptions
Medical Device Rules,2017 Content
Schedule Title
First Classification of MD and IVD
Second Fee
Third Registration and functions of Notified Bodies
Fourth Documents required for grant of mfg and Import licence
Fifth Quality Management System
Sixth Post Approval - Major and Minor Changes
Seventh Requirements to conduct Clinical Investigation
Eight Exemptions
Medical Device Rules, 2017-Schedules
Salient Points
Salient Points....
Provisions related to the ‘essentials principles of safety and performance’ for
manufacturers have been specified in the rules.
Fifth schedule in MDR-2017 describes quality management system (QMS)
which needs to be complied by the manufacturer for the design and
development, manufacture, packaging, labeling, testing, installation and
servicing of medical devices and in vitro diagnostic medical devices.
Separate provisions for regulation of clinical investigation of investigational
medical devices (i.e. New devices) have been made at par with international
practice.
Provision is made to designate or establish Central Government Medical
Device Testing Laboratories to verify conformance with the quality
standards.
Salient Points....
VALIDITY OF LICENSE
A license shall remain in perpetuity subject to payment of license retention
fee. Manufacturer or importer needs to be submit license retention fee after
five years until & unless it is cancelled or suspended.
A license holder shall be liable to pay a late fee, calculated at the rate of 2%
of the license retention fee for every month.
RISK BASED CLASSIFICATION
• Medical devices shall be notified by the Central Government and classified by the CLA based on the
classification rules specified in the First Schedule of the rules.
• Following are the risk Classes and the classification criteria based on the severity of risk associated
with the medical device.
Risk Criteria Risk Class
Low Class A
Low-Moderate Class B
Moderate-High Class C
High Class D
Salient Points....
Salient Points....
Manufacture of Class A and Class B will be regulated by the State LicensingAuthority concerned and notified bodies will carry out Quality ManagementSystem audit .
Manufacture of Class C and Class D will be regulated by the Central LicensingAuthority and where required assistance of experts or notified bodies will betaken;
Import of all medical devices will be regulated by the Central Licensing Authority.
Notified Bodies will be accredited by NABCB. These will, thereafter, beregistered with the CLA to assist the SLAs in verification and assessment ofQuality Management System of Medical Device Manufacturers of Class A andClass B devices.
Manufacture of Medical Device for Sale or Distribution
Class A and B
Manufacturer shall apply through Online System for Medical Devices portal
of Central Government with requisite documents as per Fourth schedule
and fees specified in Second schedule of MDR 2017.
No audit for class A device prior to grant of license.
The audit may be carried out within 120 days from the date of issue of
license.
The audit for Class B device is necessary prior to the grant of manufacturing
license and the audit shall be carried out within 90 days from the date of
application.
The notified body shall furnish its report to SLA within 30 days.
The SLA shall carry out inspections for Class A and Class B at least 2% of
the total audits carried out by notified bodies.
Manufacture of medical Device for Sale or Distribution
Class C and D
The application shall be made with requisite documents and fees through
Online System for Medical Devices portal of the Central Government to
CLA.
CLA may use the services of any expert and of a notified body and may
carry out an inspection within a period of 60 days from the date of
application.
No inspection of a medical device manufacturing site for grant of loan
license to be carried out if the site is already licensed to manufacture such
devices.
After completion of inspection , the inspection team shall forward the report
to CLA through online portal.
Salient Points....Regulatory Authorities
Device
Class
Activity
Class A Class B Class C Class D
Import CLA CLA CLA CLA
Manufacture SLA SLA CLA CLA
Permission to
conduct CIPermission from CLA
Sale SLA
QMS
Verification
by
*Notified
Body
*Notified Body CLA CLA
*Note: Notified Bodies shall be registered with Central Licencing
Authority. Prior inspection shall not be required before the grant
of manufacturing of Class A devices.
New Definitions
Medical Device
Substantial Equivalence
Predicate device
Investigational Medical Device
New in-vitro diagnostic
Clinical Investigation
Notified Body
Clinical Performance Evaluation
Salient Points….
Salient Points....
Standards of medical Devices in MDR,2017:
The medical device shall conform to the standards laid down by BIS
(Bureau of Indian Standards) or may be notified by Central Government
from time to time. If, such standards are not available then ISO, IEC or any
other pharmacopeial standard. If all are not available then device shall
conform to the validated manufacturers standard.
Recall of Medical Device (Rule - 89)If a manufacturer or authorised agent, considers that a medical device,
which has been imported, manufactured, sold or distributed, is likely to be
unsafe, such manufacturer or authorised agent shall immediately initiate
procedures to withdraw the medical device in question from the market and
immediately inform the competent authority.
Achievements of Ministry of Health & Family Welfare in the field of
Medical Devices Regulation New Online System for Medical Devices is functional for uploading the
applications for Import License and Manufacturing License of Medical devices
and IVDs, for post approval changes, registration of medical devices testing
laboratories , clinical investigation, notified bodies etc.
Classification of Medical Devices and IVDs has been finalized in consultation
with the stakeholders and uploaded in the CDSCO website.
Grouping of Medical Devices and IVDs along with essential principle checklist
has been finalized in consultation with the stakeholders and uploaded in the
CDSCO website.
Notification of Medical Device Officer and Medical Device Testing
Laboratories have been published.
CDSCO organised workshops to impart trainings various stakeholders
including State Licensing Authorities for the effective implementation of
Medical Devices Rules, 2017.
Achievements Cont.. For addressing various questions on regulatory practices in medical devices,
Frequently Asked Questions (FAQ) on medical devices and in vitro diagnostics isuploaded on CDSCO website. Also regular interactions are taking place with all thestakeholders to resolve their regulatory practices issues.
CDSCO has also started Public relations office (PRO) to assist any start-up/ innovator/ industry person in facilitating regulatory clearances.
Function from 10:00 am to 5.30 pm in all working days.
Draft Guidance on stability studies of in vitro diagnostic medical device (IVDMD).
Draft Guidance on Post-Market Surveillance of in vitro diagnostic medical device
(IVDMD).
Draft Guidance on Overview of Performance Evaluation / External Evaluation of In
vitro Diagnostic Medical Device (IVDMD)
Achievements Cont..
List of banned IVDs
Central Govt. vide G.S.R 432(E) & 433(E) dated 07/06/2012 prohibit Import,manufacture, sale, distribution and use of "Serodiagnostic test kits for diagnosisof tuberculosis“.
Central Govt. vide S.O 1352(E)dated 23/03/2018 prohibit Antibody DetectingRapid Diagnostic Tests for routine diagnosis of malaria.
Launch of Support Cells for WHO PQS for IVDs in India
for providing guidance to the Indian manufacturers for the WHOPrequalification of In Vitro Diagnostics Programme in India
1) National Institute of Biologicals in North India
2) Andhra Med-tech Zone in south India
Specification/Criteria for IVDProduct Type Specification/Criteria
HIV
HBsAg
ELISA / RAPID Sensitivity 100%
Specificity ≥ 98%
HCV ELISA Sensitivity 100%
Specificity ≥ 98%
HCV RAPID Sensitivity ≥99%
Specificity ≥ 98%
Rapid Plasma Reagin (RPR) Test
And TPHA (Hemagglutination)
Test for Syphilis
ELISA / RAPID Sensitivity ≥ 85%
Specificity ≥ 93%
Malaria Antigen Detection of Pf / Pv
(Plasmodium falciparum /
Plasmodium vivax )
RAPID 1. For the detection of Pf / Pv in all transmission
settings the panel detection score (PDS) should be at
least 75% at 200 parasite/µL.
2. False positive rate should be less than 10%
3. The invalid rate should be less than 5%
Salient Points....
Permission to import or manufacture medical device which does not
have its predicate device
Clinical investigation may not be required to be submitted where theinvestigational medical device is approved by the regulatory authorities ofeither the United Kingdom or the United States of America or Australiaor Canada or Japan and
the said device has been marketed for at least two years in that country and
the Central Licencing Authority is satisfied with the data of safety,
performance and pharmacovigilance of the device.
Achievements Cont..
Make in India- An initiative launched by the Government of India to
encourage national, as well as multi-national companies to manufacture
their products in India.
INDIAN MEDICAL DEVICE
INDUSTRY
Make in India
Policy Support
Infrastructure
Duty structure
Regulatory framework
Research & Development
Achievements Cont.. The Central Government has allowed 100% FDI in the Medical Device Sector.
Also, in the 12th five year plan, there is proposal to strengthen the drugregulatory system in the country including setting up of new testinglaboratories for medical device.
The Government of India aims to make manufacturing hub for medicaldevices and committed to provide best medical technologies to the citizens ofthe Country.
i.e. Andhra Pradesh Medtech Zone Ltd (AMTZ), Visakhapatnam dedicated forMedical Device Manufacturing reduce the cost of manufacturing up to 40%and the import dependency.
The MoHFW introduced materiovigilance programme of India (MvPI),intended to ensure the safety of devices.
Achievements Cont..
Materiovigilance programme of India
Materiovigilance programme of India was launched on 6th July 2015 at
Indian Pharmacopoeia Commission, Ghaziabad.
Indian Pharmacopoeia Commission functions as National Coordination
Centre (NCC).
Sree Chitra Tirunal Institute for Medical Sciences & Technology
(SCTIMST), Thiruvananthapuram act as National Collaborating Centre,
National Health System Resource Centre (NHSRC), New Delhi, act as
Technical support partner .
Central Drugs Standards Control Organisation (CDSCO), New Delhi,
support MvPI with experience of functioning as National regulator.
Achievements Cont..
Materiovigilance programme of India
Under MvPI, 26 Medical Devices Adverse Events Monitoring Centres have
been identified in the country to report the events on voluntary basis
(spontaneous).
In addition to this, 250 ADRs Monitoring Centres which have been established
under PvPI, have also been requested/solicited to report Adverse events/side
effects associated with the use of drugs/medical devices
Notified bodies registered with CDSCOM/s Intertek India Pvt. Ltd.
,E-20, Block B1, Mohan Cooperative, Industrial Area E-
20, Block B1, Mohan Cooperative, Industrial Area New Delhi (India) - 110044
Telephone No.: 011-41595475, 9310412823 Fax: 011-
41595460 E-Mail: [email protected]
M/s TUV Rheinland India Pvt. Ltd,
82/A West Wing, 3rd Main Road 82/A West Wing, 3rd Main Road Electronic City (India) - 560100 Telephone No.: 080- 46498030
Fax: 080 4649 8042 E-Mail: [email protected]
M/s TUV Sud South Asia Pvt. Ltd,
TUV SUD House, Off Saki ViharRoad, Saki Naka,Andheri (East), Mumbai-400072.Telephone No.:
022-49035508 Fax: 022-49035508E-Mail: info@tuv-
sud.in
M/s, Dnv Gl Business Assurance India Private Limited Equinox Business Park,
Tower 3, 6th Floor, BKC, LBS Road, KurlaWest, Mumbai-400070 (India), Telephone
No.: 022-61768909
Fax: 022-61768950 E-Mail: [email protected]
M/s, BSI Group India Pvt. Ltd.
The Mira Corporate Suites, Plot No. 1&2, Ishwar Nagar -Delhi110065
(India)Telephone No: 11-26929000, Fax: 11-26929000
M/S, BSCIC Certifications pvt. Ltd.
Flat No. 6, Shiv Shakti, GH-15, Sec-21C, Part-
3,Faridabad-121001 (India), Telephone No:
01294175513, Fax: 01294175513
M/s, TUV INTERCERT SAAR INDIA PRIVATE LIMITED
No 122/1, 3rd Main Road, Margosa Road, Malleswaram, Bangalore-560003 (India),
Telephone No: 918041285610, Fax: 918041285610
M/s, Zenith Quality Assessors Pvt. Ltd.
No. 306, 4th Floor, Sai Apex, VimanNagar, Pune-411014 (India),
Telephone No: 20-41322042, 41322043, Fax: 20-41322042, 41322043
Medical Device Testing LaboratorySerial
Number
Name of Laboratory Category of medical device
1 The National Institute of Biologicals, Noida In-Vitro Diagnostics for human Immunodeficiency virus, Hepatitis B Surface
Antigen and Hepatitis C Virus, Blood Grouping sera, Glucose Test Strip, Fully
Automated Analyser Based Glucose Reagent
2 The Central Drugs Testing laboratory, Chennai Condoms, Blood and Blood Component bags with or without anticoagulant
3 The Central Drugs Laboratory, Kolkata Surgical Dressings, Surgical Cotton, Surgical Bandages, Disinfectant
4 The Regional Drugs Testing Laboratory (RDTL), Guwahati Disposable Hypodermic Syringes, Disposable Hypodermic Needle, Disposable
Perfusion Sets, I.V. Cannulae
5 The Central Drugs Testing Laboratory, Mumbai Intra Uterine Devices (IUD) and Falope Rings, Blood and Blood Component bags
with or without anticoagulant
6 SIPRA LABS LIMITED Sanathnagar, Hyderabad, Telangana-
500018.
Copper-T, Condoms ,Sterile Hypodermic Needles, Tubal Rings ,Hypodermic
Syringes and Blood Bags
Medical Device Testing Laboratory Cont..Serial
Number
Name of Laboratory Category of medical device
7 M/s, Star Imaging & Path Lab Pvt. Ltd. situated at
4B/4, TILAK NAGAR, West Delhi, Delhi - 110018
Bilirubin (Total and Direct), Creatinine test reagent / kit, Aspartate
Amino Transferase, Alanine Amino Transferase, Uric Acid Test
reagents / kits, Total Protein test reagents /kits , Activated partial,
PT (Prothrombin Time) Test
8 M/s Alcatec Research Laboratories India Pvt Ltd
situated at 1652 MIE Part B , Bahadurgarh, --
,Haryana – 124507
Sterilized Surgical Ligatures, Sterilized Disposable Device,
Sterilised Surgical Sutures
9 Sree Chitra Tirunal Institute For Medical
Sciences & Technology Medical College
Thiruvananthapuram (India) - 695011
Cardio Vascular Devices (Biological
Evaluation as per ISO 10993), Neuroprosthesis (Biological
Evaluation as per ISO 10993), Orthopedic Implants (Biological
Evaluation as per ISO 10993), All medical devices and Materials
(Biological Evaluation as per ISO 10993), Dental Implants
(Biological Evaluation as
per ISO 10993)
Medical Device Testing Laboratory Cont..Serial
Number
Name of Laboratory Category of medical device
10 M/s, GLR Laboratories Private Limited ,
Gokulam street, Mathur,, Chennai, Tamil Nadu - 600068
Biological Evaluation as per ISO 10993 of medical
devices
11 M/s, PALAMUR BIOSCIENCES,
401 Aikya, 4th Floor, H.No-10-3-32/9/23, Opp.Faust High
School, East Marredpally, Secunderabad, Hyderabad,
Telangana - 500026
Biological Evaluation as per ISO 10993 of medical
devices
Medical Devices
Roadmap in the
India
Road map of medical devices
Comprehensive regulation of Medical Devices is important for ensuring
safety and well beings of patient’s using such Medical Devices.
It is proposed to regulate all medical devices as per the new MDR,2017
which is harmonized with IMDRF guidelines with risk based classification.
Cont…Medical devices should be regulated in a phase wise manner as following:
FIRST PHASE
All manufacturers and importers of all non-regulated Medical Devices should
register the details of the devices manufactured/imported initially on voluntarily
basis up to 18 months from the date of notification.
SECOND PHASE
Registration of Class A & B devices shall be followed by mandatory licensing
within 12 months after 18 months of registration period is over.
THIRD PHASE
Registration of Class C & D devices shall be followed by mandatory licensing
within 24 months after 18 months of registration period is over.
Thank you.
