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Page 1 of 12
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Draft for Comment Purposes (Not for Implementation) 6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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Page 2 of 12
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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Page 3 of 12
Introduction 52
53
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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Page 4 of 12
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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Page 5 of 12
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.
−
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
− It can be provided under the section
“Other” in the application
10 Written procedure for the transport of
the products to the KSA
− It can be provided under the section
“Other” in the application
11 Additional Information to Support
Application
− See Annex (2), click here for printable and
editable version
Page 6 of 12
− It can be provided under the section
“Other” in the application
12 Attestation − See Annex (3), click here for printable and
editable version
− It can be provided under the section
“Other” in the application
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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Page 7 of 12
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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Page 8 of 12
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Annexes 104
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Page 9 of 12
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
111
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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Page 10 of 12
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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Page 11 of 12
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
1
2
...
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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 :
136
Page 12 of 12
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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