MDS-G16 GUIDANCE ON IMPORTATION … GUIDANCE ON IMPORTATION REQUIREMENTS OF NON-MEDICAL IN-VITRO...

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MDS-G16

GUIDANCE ON IMPORTATION REQUIREMENTS OF

NON-MEDICAL IN-VITRO DIAGNOSTICS

Version Number: 1.0

Version Date: 28/11/2016

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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

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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

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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.

.

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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

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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

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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.

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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?

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ANNEXES

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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

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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

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مدير عام املنشأة / املفوض : الختم

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MDS-G16 GUIDANCE ON IMPORTATION … GUIDANCE ON IMPORTATION REQUIREMENTS OF NON-MEDICAL IN-VITRO...

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