متطلبات استيراد المنتجات البيولوجية ذات التلاعب البسيط المخصصة للاستخدام البشري

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),

Required Documents

A. Required Documents for Importation License

1. Purchase Order (PO) from the Beneficiary: - 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

2. Declaration of Conformity with Relavent Regulation: - It shall issued by the manufacturer - It shall contain: - manufacturer name and address - regulation Applied and Registration info. -

Flowchart

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 "GHAD sytem" - MDEL for importation activity. Healthcare providers importing devices for their own use only are not required to be licensed.

Submit the documents specified in section (A) of "Required Documents" electronically via "GHAD sytem" portion that is available on the SFDA's website.

Once satisfied that the application meets the requirements, the SFDA will issue an