project of requirements for importation of ... - sfda

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Draft for Comment Purposes (Not for Implementation) 6

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Project of Requirements for Importation of 10

Minimally Manipulated Biological Products 11

Intended for Human Application 12

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Table of Content 32

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Introduction ..................................................................................................................................... 3 34

Purpose ........................................................................................................................................ 3 35

Scope……… ............................................................................................................................... 3 36

Background ................................................................................................................................. 3 37

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Requirements ................................................................................................................................... 4 39

Required Documents ....................................................................................................................... 5 40

Flowchart ......................................................................................................................................... 7 41

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Annexes ........................................................................................................................................... 8 43

Annex (1): Application Form for Importation of Minimally Manipulated Biological Products 44

Intended for Human Application ................................................................................................. 9 45

Annex (2): Additional Information to Support Application ...................................................... 10 46

Annex (3): Attestation for Importers of Minimally Manipulated Biological Products Intended 47

for Human Application .............................................................................................................. 11 48

Annex (4): Definitions & Abbreviations ................................................................................... 12 49

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Introduction 52

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Purpose 54

The purpose of this document is to specifiy and clarify the importation requirements for minimally 55

manipulated biological products intended for human application. 56

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Scope……… 59

These requirements apply to following establishments and products: 60

A. importers and healthcare providers importing for their own use 61

B. minimally manipulated biological products (e.g. bone ligaments, tendons, fascia, cartilage, 62

ocular tissues (corneas and sclera), skin, vascular grafts (veins and arteries except preserved 63

umbilical cord veins), pericardium, amniotic membrane (when used alone without added 64

cells for ocular repair), heart valve allografts), excluding the following: 65

o vascularized organs (liver, kidney, lung, heart,….etc.) 66

o major manipulation (e.g. advanced therapeutic drug, gene therapy, tissues 67

engineering therapy) 68

o biologic products imported for research purposes. 69

o biologic products derived from non-humans sources. 70

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Background 73

SFDA has issued these requirements in reference to article two of the “Implementation Regulation 74

on The Law of Saudi Food and Drug Authority” issued by Saudi Food and Drug Authority Board 75

of Directors decree no. (7-7-1428) dated 25/7/1429 H, stipulating that the SFDA is responsible for 76

regulating biological products. 77

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Requirements 84

General 1 Minimally manipulated biological products intended for human

application shall not be imported unless an importation license is

obtained from SFDA.

Prerequisite 2 Before applying for an importation license, importers shall have:

− an establishment account in “The Portal of the Electronic

Services of Saudi Food and Drug Authority”

− MDEL for importation activity. Healthcare providers

importing devices for their own use only are not required to be

licensed.

Submitting to

SFDA

3 Applicant shall submit the “Application Form for Importation of

Biological Product (Annex1)” electronically via “Medical Device

Importing License (MDIL)” on the SFDA’s website, and provide

“Required Documents” specified in section (A).

Once satisfied that the application meets the requirements, the SFDA

will issue an importation license, valid for (90) days, then send it to the

applicant’s email.

Shipment

Clearance at the

Ports of Entry

4 A. For the purpose of shipment clearance at the ports of entry,

applicant shall submit documents specified in section (B) of

"Required Documents" according to “Guidance on Requirements

of Shipments Clearance (MDS-G21)”.

B. Each shipment that requires specific temperature for transportation

and/or storage shall contain temperature indicator activated from

the time of shipping.

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https://ghad.sfda.gov.sa/en/

https://ghad.sfda.gov.sa/en/

https://www.sfda.gov.sa/ar/Rud/Pages/default.aspx

https://www.sfda.gov.sa/en/medicaldevices/regulations/Pages/DownloadPageForm.aspx?keyDId=30&ListId=1&LangID=1

https://www.sfda.gov.sa/en/medicaldevices/regulations/Pages/DownloadPageForm.aspx?keyDId=30&ListId=1&LangID=1

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Required Documents 88

Required Documents Note

A. Required Documents for Importation License

1 Purchase Order (PO) from the

Beneficiary

− It shall contain:

o product name (trade and scientific)

o quantity

o country of origin

o manufacturer name

o start and end date of importing

2 Declaration of Conformity with

Relavent Regulation

− It may include:

o license delivered by the competent

authority of the country of origin of the

product(s)

o free sale of certificate

3 Purchase Invoice − It shall be stamped by the concerned

authority for trade in the country of origin

(if applicable)

− It shall include detailed description of the

shipment, quantity, expiration date (if

applicable), model/part number and

lot/serial number

4 Certificate of Saudi Center for Organ

Transplantation for the beneficiary

− It is required only if the product is cornea

5 Evidance that the source of the product

is registered/accredited in the country of

origin.

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6 Bill Of Lading (B/L) or the Air Waybill

(AWB)

7 Country of Origin Certificate

8 Label(s) affixed on the primary and

external packaging

− It can be provided under the section

“Other” in the application

9 Documentation accompanying the

products to the end users



10 Written procedure for the transport of

the products to the KSA



11 Additional Information to Support

Application

− See Annex (2), click here for printable and

editable version

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12 Attestation − See Annex (3), click here for printable and

editable version



B. Required Documents for Shipment Clearance

13 Importation License − It shall be valid

14 Purchase Invoice − It shall be authenticated by the chamber of

commerce in the country of origin

− It shall contain the invoice number,

manufacturer’s name, products name,

quantity, and unit price

− Model/part numbers and lot/serial numbers

shall be indicating in the invoice or packing

list

15 Bill Of Lading (B/L) or the Air Waybill

(AWB)

−

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Flowchart 94

Yes

Start

Establishments, specified in the scope of this document, shall obtain

an importation license from SFDA.

Before applying for an importation license, they shall have:

an establishment account in The Portal of the Electronic Services

of Saudi Food and Drug Authority

MDEL for importation activity. Healthcare providers importing

devices for their own use only are not required to be licensed.

End

Is the product specified in

the scope of this

document?

Submit the documents specified in

section (A) of Required Documents

electronically via Medical Device Importing

License portion that is available on the

SFDA s website.

Once satisfied that the application meets the

requirements, the SFDA will issue an

importation license, valid for (90) days, then

send to the applicant s email.

For the purpose of shipment clearance at the

ports of entry, the applicant shall submit the

documents specified in section (B) of

Required Documents .

abiding by the

provisions of the

Attestation

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Annexes 104

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Annex (1): Application Form for Importation of Minimally Manipulated 107

Biological Products Intended for Human Application 108

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إ)يعبأ ً 110 ) الهيئةموقع عبر لكترونيا

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A. Importer information بيانات المستورد .أ Importer: المستورد:

Establishment National Registry Number, if

available:

إن وجد (MDNRأة )رقم السجل الوطني للمنش

Commercial Registration Number (it is required

if the establishment is comerical):

أن)ينطبق فقط في حال رقم السجل التجاري :المستورد مؤسسة/شركة تجارية(

MDEL license Number (it is not required if the

importer is healthcare provider):

(MDEL) رخصة المنشأةرقم مقدم رعاية المستورد أن ينطبق فقط في حال لا )

(صحيةPhone number: هاتف: Fax: )فاكس )إن وجد: Email: البريد الإلكتروني: Address: العنوان: P.O. Box : صندوق البريد:

Authorized person name:

:اسم الشخص المفوض

National ID: رقم الهوية: Contact details: وسيلة الاتصال: B. Shipment Information بيانات الشحنة .ب Storage place: مكان التخزين: Country of origin: دولة المنشأ: Beneficiary: الجهة المستفيدة: Manufacturer: الصانعة الشركة: Shipping company: شركة الشحن: Port of Entry: الوصول منفذ: Airway bill: رقم البوليصة: C. Products Information بيانات المنتجات .ت Purchase invoice number: رقم فاتورة الشراء: Purchase invoice date: تاريخ فاتورة الشراء: Item name: البنداسم: Lot number: رقم التشغيلة: Expiry date: الصلاحية تاريخ انتهاء: Quantities: الكمية: Item unit: وحدة الكمية:

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Annex (2): Additional Information to Support Application 113

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1 The name and type of final products to be

imported

2 The name, address, and contact details of

the suppliers of the final products if

different from the importer

3 A brief description of the procedure used

for ensuring the traceability of the products

from donor to recipient

4 The type of primary and external packaging

used for storage and transport.

5 A brief description of the process used for

manufacturing the final product

6 A brief description of the system in place

by the importer of the final product to

notify the SFDA in case of any serious

adverse event

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Annex (3): Attestation for Importers of Minimally Manipulated 117

Biological Products Intended for Human Application 118

Click here for printable and editable version 119

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123 تية:بأن المنتجات الطبية الحيوية الآ ..........................................................نحن شركة / مؤسسة /مستودع

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بلد الصنع المصنّع عدد البنود تاريخ الفاتورة رقم الفاتورة م

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126 :نتعهد بالآتي

127 المصنّع. متطلباتوالتخزين حسب النقل .1

128عن أي تفاعل ضار بشكل عاجل الطبيةوالمنتجات المركز الوطني لبلاغات الأجهزة الهيئة من خلال المصنّع و إبلاع .2

129 .بسبب استخدام المنتجيحدث

130 .ذات العلاقةسجلات المستدات والتعقب/تتبع المنتج اثناء الاستخدام والاحتفاظ ب .3

131 .المنتجات في الغرض الذي جلت من أجلهاستخدام .4

132 .أو مواد متفجرة أو مواد مشعة أو أي مواد محظورةأن الشحنة لا تحتوي على أي مواد مخدرة .5

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135 ولكم جزيل الشكر والتقدير ،،،،

الختم

اسم الشخص المســؤول :

المسمى الوظيفــــــــــي :

التوقيــــــــــــــــــــــــع :

التاريـــــــــــــــــــــــخ :

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https://ncmdr.sfda.gov.sa/

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Annex (4): Definitions & Abbreviations 137

KSA Kingdom of Saudi Arabia

SFDA Saudi Food and Drug Authority

MDEL Medical Device Establishment License

National Center for

Medical Device

Reporting (NCMDR)

an organization managing a database of information on safety and/or

performance related aspects of medical devices and employing staff

capable of taking appropriate action on any confirmed problems.

Labeling means written, printed or graphic matter

A. Affixed to a medical device or any of its containers or

wrappers.

B. Information accompanying a medical device, related to

identification, technical description.

C. Information accompanying a medical device, related to its

use, but excluding shipping documents.

Human cells, tissues, or

cellular or tissue-based

products (HCT/Ps)

means articles containing or consisting of human cells or tissues that

are intended for implantation, transplantation, infusion, or transfer

into a human recipient. Examples of HCT/Ps include, but are not

limited to, bone, ligament, skin, dura mater, heart valve, cornea

Human Application means the use of tissues or cells on or in a human recipient and

extracorporal applications.

Minimal Manipulation

for Structural Tissue

means processing that does not alter the original relevant

characteristics of the tissue relating to the tissue's utility for

reconstruction, repair, or replacement.

Minimal Manipulation

for Cells or

Nonstructural Tissues

means processing that does not alter the relevant biological

characteristics of cells or tissues.

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