Requirements for Importation of Minimally Manipulated Biological Products Intended for Human Application

sfda_gov_sa · regulation · processed · 7 chunks

Requirements for Importation of Minimally Manipulated Biological Products Intended for Human Application

Version Number: 2.0
Version Date: 22/7/2020
This guidance document has been published after being distributed for public comments dated on 29/9/2019 for 30 days.
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Table of Content
Introduction....3
Purpose 3
Scope....3
Background 3
Requirements....4
Required Documents 5
Flowchart....7
Annexes 8
Annex (1): Application Form for Importation of Minimally Manipulated Biological Products Intended for Human Application....9
Annex (2): Attestation for Importers of Minimally Manipulated Biological Products Intended for Human Application....10
Annex (4): Definitions & Abbreviations....11
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Introduction
Purpose
The purpose of this document is to specify and clarify the importation requirements for minimally manipulated biological products intended for human application.
Scope
These requirements apply to following products and establishments:
A. minimally manipulated biological products (e.g. bone ligaments, tendons, fascia, cartilage, ocular tissues (corneas and sclera), skin, vascular grafts (veins and arteries except preserved umbilical cord veins), pericardium, amniotic membrane (when used alone without added cells for ocular repair), heart valve allografts), excluding the following:
○ vascularized organs (liver, kidney, lung, heart, ....etc.)
major manipulation (e.g. advanced therapeutic drug, gene therapy, tissues engineering therapy)
○ biologic products imported for research purposes.
○ biologic products derived from non-humans sources.
○ biologically-derived medical devices
B. importers and healthcare providers importing for their own use.
Background
SFDA has issued these requirements in reference to article two of the “Implementation Regulation on The Law of Saudi Food and Drug Authority” issued by Saudi Food and Drug Authority Board of Directors decree no. (7-7-1428) dated 25/7/1429 H, stipulating that the SFDA is responsible for regulating biological products.
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Requirements
<table><tr><td>General</td><td>1</td><td>Minimally manipulated biological products intended for human application shall not be imported unless an importation license is obtained from SFDA.</td></tr><tr><td>Prerequisite</td><td>2</td><td>Before applying for an importation license, importers shall have:- an establishment account in “GHAD sytem”- MDEL for importation activity. Healthcare providers importing devices for their own use only are not required to be licensed.</td></tr><tr><td>Submitting to SFDA</td><td>3</td><td>Applicant shall submit the “Application Form for Importation of Biological Product (Annex1)” electronically via “GHAD sytem” 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.*Note: For special circumstances the SFDA may grant the importation license for one year to health care provider according to its annual need.</td></tr><tr><td>Shipment Clearance at the Ports of Entry</td><td>4</td><td>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.</td></tr></table>
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Required Documents
<table><tr><td></td><td>Required Documents</td><td>Note</td></tr><tr><td colspan="3">A. Required Documents for Importation License</td></tr><tr><td>1</td><td>Purchase Order (PO) from the Beneficiary</td><td>- It shall contain:○ product name (trade and scientific)○ quantity○ country of origin○ manufacturer name○ start and end date of importing- It is not required if healthcare provider importing for their own use</td></tr><tr><td>2</td><td>Declaration of Conformity with Relavent Regulation</td><td>- It shall issued by the manufacturer- It shall contain:○ manufacturer name and address○ regulation Applied and Registration info.○ the applied quality management system○ product details (brand name , product type, description , intended purpose/use and sizes) .</td></tr><tr><td>3</td><td>Purchase Invoice</td><td>- 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</td></tr><tr><td>4</td><td>Certificate of Saudi Center for Organ Transplantation for the beneficiary</td><td>- It is required only if the product is cornea.- It can be provided under the section “Other” within the application</td></tr><tr><td>5</td><td>Evidence that the source of the product is registered/accredited in the country of origin.</td><td>- It may includes:○ Establishment registration○ Accreditation Certificate- It can be provided under the section “Other” within the application</td></tr><tr><td>6</td><td>Labelling of each product</td><td>- It shall cover all models- It can be provided under the section “Other” within the application</td></tr><tr><td>7</td><td>Documentation accompanying the products to the end users (such as instruction of use IFU )</td><td>- It can be provided under the section “Other” within the application</td></tr><tr><td>8</td><td>Attestation</td><td>- See Annex (2), click here for printable and editable version</td></tr></table>
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<table><tr><td></td><td></td><td>- It can be provided under the section “Other” within the application</td></tr><tr><td colspan="3">B. Required Documents for Shipment Clearance</td></tr><tr><td>9</td><td>Importation License</td><td>- It shall be valid</td></tr><tr><td>10</td><td>Purchase Invoice</td><td>- 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- The quantity mentioned in the purchase invoice will deduct from annual need quantity for health care provider. (if the importation license for annual need</td></tr><tr><td>11</td><td>Bill Of Lading (B/L) or the Air Waybill (AWB)</td><td>-</td></tr></table>
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Flowchart

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Annexes

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Annex (1): Application Form for Importation of Minimally Manipulated Biological Products Intended for Human Application
نموذج طلب استيراد منتجات حيويت علاجيه
(يعبا الكترونيا عبر موقع الهييه)
<table><tr><td>A. Importer information</td><td>ا. بيانات المستورد</td></tr><tr><td>Importing Type:</td><td>نوع الاستيراد:</td></tr><tr><td>Manufacturer Name:</td><td>اسم المصنع:</td></tr><tr><td>Country</td><td>البلد</td></tr><tr><td>City</td><td>المدينه</td></tr><tr><td>Postal Code:</td><td>الرمز البريدي:</td></tr><tr><td>Manufacturer Details:</td><td>تفاصيل المصنع:</td></tr><tr><td>Email:</td><td>البريد الالكتروني:</td></tr><tr><td>Telephone Number:</td><td>الهاتف:</td></tr><tr><td>Mobile Number:</td><td>رقم الجوال :</td></tr><tr><td>B. Shipment Information</td><td>ب. بيانات الشحنه</td></tr><tr><td>Product Type:</td><td>نوع المنتج:</td></tr><tr><td>Purpose of Importing:</td><td>الغرض من الاستيراد:</td></tr><tr><td>Shipment Country:</td><td>بلد الشحن:</td></tr><tr><td>Shipment Company:</td><td>شركه الشحن:</td></tr><tr><td>Shipment Policy Number:</td><td>رقم بولисصه الشحن:</td></tr><tr><td>Arrival Port:</td><td>ميناء الوصول:</td></tr><tr><td>Storage Place:</td><td>مكان التخزين:</td></tr><tr><td>Benificiary Name:</td><td>اسم المستفيد:</td></tr><tr><td>Beneficiary Mobile:</td><td>رقم هاتف المستفيد:</td></tr><tr><td>Beneficiary Address:</td><td>عنوان المستفيد:</td></tr><tr><td>Benificiary Email:</td><td>البريد المستفيد الالكتروني:</td></tr><tr><td>C. Products</td><td>ت. المنتج</td></tr><tr><td>Product Name:</td><td>اسم المنتج</td></tr><tr><td>Status</td><td>الحاله</td></tr><tr><td>Quantity:</td><td>الكميه</td></tr><tr><td>Has MDMA:</td><td>MDMA لدي</td></tr><tr><td>Registered:</td><td>مسجل</td></tr><tr><td>Ingredients / Components:</td><td>المكونات</td></tr><tr><td>Invoice Number:</td><td>رقم الفاتوره</td></tr><tr><td>Related to List:</td><td>ذات الصله الي القايمه:</td></tr><tr><td>D. Documents</td><td>ث. المستندات</td></tr><tr><td>Shipment Policy</td><td>بوليصه الشحن</td></tr><tr><td>Agreement Letter with the beneficiary</td><td>تعميد الشراء/ امر الشراء من الجهه المستفيده</td></tr><tr><td>Other Files</td><td>ملفات اخري</td></tr></table>
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Annex (2): Attestation for Importers of Minimally Manipulated
Biological Products Intended for Human Application
Click here for printable and editable version
النتايج
يطبع علي الورق الرسمي الخاص بالمورد
تمه
واشاره الي طلبنا استيراد المنتجات الطبيه الحيويه الاتيه: نحن
<table><tr><td>بلد الصنع</td><td>المصنع</td><td>عدد البنود</td><td>اسم المنتج</td><td>م</td></tr><tr><td></td><td></td><td></td><td></td><td>1</td></tr><tr><td></td><td></td><td></td><td></td><td>2</td></tr><tr><td></td><td></td><td></td><td></td><td>...</td></tr></table>
نتعهد بالاتي:
1. تقديم فاتوره مفصله مع كل شحنه قادمه.
٢. النقل والتخزين حسب متطلبات المصع.
ابلاع المضع والهينه من خلال المركز الوطني للالاغات الاجنبيه والمنتجات الطبيه بشكل عاجل عن اي تفاعل ضار
يحدث بسبب استخدام المنتج.
تعقب/بتع المنج اثناء الاستخدام والاحتفاط بالمنیدات والدعجات ذات العلاقه.
استخدام المنتجات في الغرض الذي جلبت من اجله.
بنود الشحه الوارده تحتوي علي:
لا □ نعم □
مواد مشعه ٦١
(اذا كانت الاجابه نعم)
اسم الماده المشعه:
لا □ نعم □
مواد كيماييه خاضعه لرقابه الامن العام ٦١
(اذا كانت الاجابه نعم)
اسم الماده الكيماييه:
لا □ نعم □
مواد مخدره ٦٣
(اذا كانت الاجابه نعم)
اسم الماده المخدره:
ولكم جزيل الشكر والتقدير،،،،
: اسم الشخص المسؤول
المسمي الوظيفي :
: التوقيع
الختم
: التاریخ
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Annex (4): Definitions & Abbreviations
<table><tr><td>KSA</td><td>Kingdom of Saudi Arabia</td></tr><tr><td>SFDA</td><td>Saudi Food and Drug Authority</td></tr><tr><td>MDEL</td><td>Medical Device Establishment License</td></tr><tr><td>National Center for Medical Device Reporting (NCMDR)</td><td>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.</td></tr><tr><td>Labeling</td><td>means written, printed or graphic matterA. 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.</td></tr><tr><td>Human cells, tissues, or cellular or tissue-based products (HCT/Ps)</td><td>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</td></tr><tr><td>Human Application</td><td>means the use of tissues or cells on or in a human recipient and extracorporal applications.</td></tr><tr><td>Minimal Manipulation for Structural Tissue</td><td>means processing that does not alter the original relevant characteristics of the tissue relating to the tissue&#x27;s utility for reconstruction, repair, or replacement.</td></tr><tr><td>Minimal Manipulation for Cells or Nonstructural Tissues</td><td>means processing that does not alter the relevant biological characteristics of cells or tissues.</td></tr></table>
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