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Medical Device Free Sale Certificate (FSC): Definitions, Roles, Differences from Registration Certificates, and Application Process

Ⅰ. Definition

A Medical Device Free Sale Certificate (FSC) is a document issued by the competent authority or certification body in the country or region where the medical device manufacturer or supplier is located. It serves as proof that a specific medical device is legally and freely sold in its country of origin or region, and complies with the corresponding regulations and standards.

Ⅱ. Roles

Proof of Compliance: This certificate demonstrates that the medical device has passed the review and approval of the regulatory agency in the country of origin or region, and complies with local regulations and standards.

Support for International Trade: The Medical Device Free Sale Certificate is often used to support international trade in medical devices, especially when entering certain countries or regional markets, proving that the product meets the requirements in its country of production or region.

Elimination of Doubts: For the regulatory agencies in the importing country, this certificate helps eliminate doubts about the compliance of medical devices, promoting international exchange and sales of medical devices.

Ⅲ. Differences from Medical Device Registration Certificates

Medical Device Free Sale Certificates and Medical Device Registration Certificates are two distinct concepts. A Medical Device Registration Certificate is issued by the health department or medical device regulatory agency in the target sales market, proving that the medical device has been registered or licensed in the target market, meets the regulations and standards of that market, and can be legally sold and used. In contrast, Medical Device Free Sale Certificates are more commonly used for international market access, proving the legal sale of medical devices in their country of production or region. In some cases, some countries may require the provision of a Medical Device Free Sale Certificate as part of the application for medical device registration.

Ⅳ. Application and Processing

The steps for obtaining a Medical Device Free Sale Certificate may vary depending on the regulatory requirements of the country or region and the procedures of the certification body. Typically, exporters, manufacturers, or suppliers need to submit an application to the competent authority or certification body in their country or region, along with the necessary documents as required. These documents may include detailed information about the product, descriptions of the production process, proof of the quality control system, etc.

In summary, the Medical Device Free Sale Certificate is an important certification document in international medical device trade. It proves the legal sale and compliance of medical devices in their country of origin or region, helps eliminate doubts in the importing country, and promotes international exchange and sales of medical devices.