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Page 1 of 12
MDS-G16
GUIDANCE ON IMPORTATION REQUIREMENTS OF
NON-MEDICAL IN-VITRO DIAGNOSTICS
Version Number: 1.0
Version Date: 28/11/2016
Page 2 of 12
TABLE OF CONTENT
DEFINITIONS & ABBREVIATIONS ........................................................................................ 3
Definitions .................................................................................................................................... 3 Abbreviations ............................................................................................................................... 3
INTRODUCTION ......................................................................................................................... 4
Purpose ......................................................................................................................................... 4 Scope……. ................................................................................................................................... 4 Background .................................................................................................................................. 4
REQUIREMENTS ........................................................................................................................ 5
REQUIRED DOCUMENTS......................................................................................................... 6
FLOWCHART .............................................................................................................................. 8
ANNEXES ...................................................................................................................................... 9
Non-Medical IVDs Application Form........................................................................................ 10 Non-Medical IVDs Attestation Form ......................................................................................... 11
Page 3 of 12
DEFINITIONS & ABBREVIATIONS
Definitions
Abbreviations
KSA Kingdom of Saudi Arabia
MOI Ministry Of Interior
SFDA Saudi Food and Drug Authority
MDS Medical Devices Sector
IVD In-Vitro Diagnostic
MDIL Medical Devices Importation Licence
Page 4 of 12
INTRODUCTION
Purpose
The purpose of this guidance is to clarify the requirements for obtaining an importation license
and a clearance for non-medical IVDs.
Scope…….
This guidance applies to importers of non-medical IVDs excluding the following:
o Radioactive materials
o Chemicals
o Non-medical IVDs containing any of the components identified in “Chemical Weapons
Convention”
Background
In accordance with “The Law of Saudi Food and Drug Authority” issued by the Royal Decree
No.(M/6) issued on 25/1/1428 H, stipulating that SFDA shall regulate the IVDs, and in accordance
with “The Law of Chemical Materials Importing and its Management” issued by the Royal Decree
No. (M/38) dated 16/6/1427H, stipulating that an authorization shall be obtained for importation
and clearance of non-medical IVDs; SFDA/MDS undertakes the responsibility of issuing an
importation license and a clearance for non-medical IVDs in collaboration with the MOI to ensure
that they are imported for the intended purpose.
.
Page 5 of 12
REQUIREMENTS
Non-medical IVDs shall NOT be imported unless MDIL is obtained
from SFDA/MDS.
1 General
Importers may request a classification for the product intended to be
imported, in order to know whether they are subject to SFDA/MDS
regulation or not. For more information, refer to the SFDA’s website.
2
Applicants shall submit the documents specified in section (1) of
"REQUIRED DOCUMENTS” electronically via MDIL portion that
is available on the SFDA’s website.
3 Submitting to
SFDA
A. Once satisfied, SFDA will send an MDIL to the applicant’s email.
The MDIL will be valid for 90 days and could be issued to cover
the annual needs.
B. If the product contains any component under MOI control, the
MDIL will be conditional to MOI approval. In this case, SFDA
will refer the request to MOI and provide the reference number to
the applicant for the follow up.
4 MDIL Approval
Process
A. The labeling of the product shall include manufacturer’s name
and address, county of origin and product name.
B. Each shipment that requires specific temperature for
transportation and/or storage, according to the manufacturer
instructions, shall contain temperature indicator activated from
the time of shipping.
5 Clearance at the
Ports of Entry
The importer shall abide by the provisions of “Non-Medical IVDs
Attestation Form” (Annex 2).
6 Importers’
Responsibility
Page 6 of 12
REQUIRED DOCUMENTS
Notes Sample Required Documents
1. Required Documents for MDIL
1.1 General
See points (3) and (4) of
"REQUIREMENTS” in this document
See
Annex 1
Non-Medical IVDs
Application Form
1
It shall be valid
Governmental establishments are
exempt
- Copy of the Business
Registration Certificate
2
If the Conformity Letter is unavailable,
the applicant shall provide a document
that proves that the product is non-
medical IVD, such as:
o user manual
o catalog
o Clarification letter issued by the
manufacturer.
Note: If not proved, the applicant shall
submit a classification request. For
more information, refer to the SFDA’s
website.
- Conformity Letter that
indicates that the product is
classified as a non-medical
IVD
3
It shall be issued by the manufacturer
If it does not indicate the components
and the percentage of each component,
then the product’s certificate of
analysis shall be provided.
- Copy of the Material Safety
Data Sheet
4
- - Copy of the Country of
Origin Certificate
5
- - Copy of the PO from the
beneficiary or Civil Defense
License for the warehouse
6
It shall be on the importer’s official
letter
See
Annex 2
Non-Medical IVDs
Attestation Form
7
It shall be issued by the manufacturer,
and if not, the applicant shall provide a
copy of the agreement/authorization
letter between the manufacturer and the
establishment that issued the invoice
It shall include expiry date and lot
number.
- Copy of Purchase Invoice 8
Page 7 of 12
If any - Copy of the Bill Of Lading
(B/L) or the Air Waybill
(AWB)
9
1.2 If the product contains any component under MOI control
(SFDA determines whether the product is subject to MOI control or not)
It shall be valid
The warehouse activity shall be
“Chemical Materials”
The license shall pertain to the
importer. For leased warehouses, a
valid lease contract shall be provided
together with the owner’s civil defense
license
- Civil Defense License for the
warehouse
10
- - Storage warehouse location
(Sketch)
11
It shall be issued by the manufacturer
Measuring unit shall be in Kilogram or
Liter
- Component details in terms
of weight or volume
12
It shall be signed and stamped by a
representative of the importer
It can be obtained
MOIfrom
A form indicates the already
cleared, dispensed and
remaining quantity in the
warehouse
13
It shall be signed and stamped by a
representative of the importer
- Clearance Application form
MOI
14
2. Required Documents for Shipments Clearance at the Ports of Entry
It shall be valid - Copy of the importation
license for non-medical IVDs
(MDIL)
15
It shall be authenticated by the chamber
of commerce in the country of origin
and shall contain the invoice number,
manufacturer’s name and detailed
description of the shipment (name of
each product, quantity, unit price,
model/part number and lot/serial
number)
- Original Purchase Invoice
16
It shall be stamped by the concerned
authority for trade in the country of
origin.
- Original Country of Origin
Certificate
17
Note: Each shipment that requires specific temperature for transportation and/or storage,
according to the manufacturer instructions, shall contain temperature indicator activated from
the time of shipping.
Page 8 of 12
FLOWCHART
I do not
know
Yes
Start
In case the SFDA decides the product is
Non-Medical IVD
No
End
Submit
a classification request
Applicants shall submit the documents
specified in section (1.1.) of "REQUIRED
DOCUMENTS” electronically via MDIL
portion that is available on the SFDA’s
website
Once satisfied, SFDA will send an MDIL to
the applicant’s email. The MDIL will be
valid for 90 days and could be issued to
cover the annual needs.
Once satisfied, SFDA will send an MDIL to
the applicant’s email. The MDIL will be valid
for 90 days and could be issued to cover the
annual needs.
The MDIL will be conditional to MOI
approval. In this case, SFDA will refer the
request to MOI and provide the reference
number to the applicant for the follow up
For the purpose of shipment
clearance at the ports of entry,
the applicant shall submit the
documents specified in section
(2) of "REQUIRED
DOCUMENTS".
The importer shall abide by
the provisions of “Non-
Medical IVDs Attestation
Form” (Annex 2).
The product shall not contain any of the
components in “Chemical Weapons
Convention”
Does the
product contain any
component under MOI control?
(SFDA determines whether the product is
subject to MOI
control or not)
Yes
Provide the documents
specified in section (1.2.) of
"REQUIRED DOCUMENTS”
Is the product
Non-Medical IVD?
Page 9 of 12
ANNEXES
Page 10 of 12
Annex 1
Non-Medical IVDs Application Form
املخبرية غير الطبيةلكواشف ا دنموذج طلب إذن استيرا (Electronic submission through SFDA website)
التاريخ
املستورد
التجاري السجل رقم
هاتف
فاكس
االلكرتوني الربيد
العنوان
الربيد صندوق
املفوض الشخص اسم
املفوض الشخص صفة
املفوض الشخص هوية رقم
املفوض اتصال بالشخص وسيلة
عدد البنود
دولة املنشأ
مكان التخزين
مكان تركيب اجلهاز
الغرض من االستخدام
اجلهة املستفيدة
الشركة الصانعة
شركة الشحن
رقم البوليصة
منفذ الوصول
اسم البند
التشغيلةرقم
ةتاريخ انتهاء الصالحي
الكمية
وحدة الكمية
تسلسل الفاتورة
Page 11 of 12
الكواشف غير طبية املطلوبة الذن استيراد ( املستندات1) الفقرة – املستندات املطلوبةأنظر املستندات املشار إليها في قسم
Annex 2
Non-Medical IVDs Attestation Form
طبية النموذج تعهد طلب إذن استيراد كواشف مخبرية غير
املحترم سعادة / نائب الرئيس لقطاع األجهزة واملنتجات الطبية
الهيئة العامة للغذاء والدواء
إلى خطابنا رقم غير طبيةمخبرية واملتضمن طلب إذن استيراد كواشف ......................... بتاريخ ............. ...................إشارة
الواردة في الفاتورة / الفواتير أدناه:
بلد الصنع الشركة املصنعة عدد البنود تاريخ الفاتورة رقم الفاتورة م
1
2
3
4
و ......................................نتعهد نحن شركة / مؤسسة / مستودع .....................................................والقادمة عن طريق منفذ
باآلتي:....................... فرع ...................... وتاريخ ..................... سجل تجاري رقم
تورة / الفواتير مطابقة للشروط واملعايير الدولية. أن بنود الشحنة الوارد في الفا .1
.والهيئة العامة للغذاء والدواء مراعاة شروط النقل والتخزين حسب توصيات الشركة الصانعة .2
بأن البنود الواردة الشحنة ال تحتوي على أي مواد مخدرة أو مواد متفجرة أو مواد مشعة أو أي مواد محظورة. .3
هادة املنشأ لدى منفذ الوصول.إحضار أصل الفاتورة وش .4
(.HIVعدم احتواء الكواشف على العامل املسبب ملرض االيدز ) .5
باإلضافة إلى عدم تداولها في غير األماكن ااستخدام املواد املطلوب استيرادها في األغراض املجلوبة من أجله .6
األضرار الناجمة عن سوء استخدام املواد املذكورة في طلب إذن االستيراد أو وتحمل جميعاملخصصة لذلك
.استخدامها في غير الغرض الذي جلبت من أجله
7. . وعمليا
األفراد القائمين بالعمل مؤهلين علميا
8. االحتفاظ باملستندات وسجالت بيانات الكميات الواردة واملنصرفة واملستهلكة سنويا
Page 12 of 12
مدير عام املنشأة / املفوض : الختم
التوقيـــــــــــــــــــــــــــــــــع :
التاريــــــــــــــــــــــــــــــــــخ :