Standard Certificate of Free Sale

Posted on News 17 Views

Standard Certificate of Free Sale (CFS) in Medical Device Importation

1. Overview of the Certificate of Free Sale (CFS)

The Certificate of Free Sale (CFS) is an official document issued by the competent authority of the exporting country. Certifying that the product (in this case, a medical device) is freely sold in the domestic market of that country without any legal restrictions or prohibitions. The CFS plays a critical role in the process of importing medical devices into many countries. Including Vietnam, ensuring that the product meets the quality and safety standards of the exporting country.

2. Standard Requirements for a Certificate of Free Sale (CFS)

To be accepted in the process of importing medical devices into Vietnam, the CFS must meet the following specific requirements:

  • Clear identification of origin and manufacturer information:

    • The certificate must clearly state the manufacturer’s information. Including the full name, address, and the country where the medical device was manufactured or first sold. This information not only confirms the origin of the product but also serves as a basis for regulatory authorities to assess the legality and reliability of the product.

  • Detailed product information:

    • The CFS must provide detailed information about the product, including the trade name, product code, medical device classification code (if applicable), and a brief description of the device’s function and intended use. This ensures that the imported product matches the technical standards that have been published and prevents confusion with other products.

  • Authorized issuing authority:

    • The certificate must be issued by a competent government authority or a government-authorized organization in the exporting country, typically the Ministry of Health or a regulatory body for pharmaceuticals and medical devices. CFS issued by private organizations or companies are generally not accepted unless specifically allowed by the importing country’s regulations.

  • Confirmation of free sale status:

    • The CFS must explicitly state that the product has been approved and is freely sold in the exporting country without any legal or technical restrictions. This information must be detailed and comprehensive, confirming that the product has undergone inspection, testing, and meets the quality standards of the issuing country.

  • Validity period of the CFS:

    • The CFS must have a clearly defined validity period, typically ranging from 1 to 2 years from the date of issuance. A certificate that is expired or no longer valid will result in the product being denied import. In some cases, the importing country may require the CFS to be valid for at least 6 months from the date of submission of the import application.

  • Language and legal translation of the CFS:

    • The CFS must be issued in English or Vietnamese. If the certificate is issued in another language, it must be accompanied by a notarized translation into English or Vietnamese, complying with legal translation requirements and authenticated by the competent authority in the importing country.

  • Official signature and seal:

    • The CFS must bear the signature of an authorized person from the issuing authority, along with the official seal of that authority. If a digital signature or electronic seal is used, the certificate must comply with international electronic certification regulations and be recognized as valid by the importing country.

3. Procedures for Using the CFS in Medical Device Importation in Vietnam

The process of importing medical devices into Vietnam is complex and requires strict adherence to legal regulations and quality standards. The CFS plays a vital role in ensuring that imported medical devices meet the required safety and quality standards.

  • Submission of import documents:

    • When submitting an application for an import license for medical devices, the company must include a valid CFS along with other documents such as a quality certificate, license for sale in the exporting country, and technical documentation of the product. The CFS must be attached as an original or a certified copy and translated if necessary.

  • Verification and validation:

    • The customs authority and the medical device regulatory authority in Vietnam will review and verify the validity of the CFS, including cross-referencing the information in the application and checking the authenticity of the certificate. This process may involve requesting verification from the issuing authority in the exporting country.

  • Customs clearance and licensing:

    • Once the CFS and related documents are confirmed to be valid, the authorities will proceed with customs clearance and issue a license for the medical device to be distributed in Vietnam. If there are any issues with the CFS, the authorities may request additional documents or refuse to grant the import license.

4. Important Considerations When Using a CFS

  • Ensure the legitimacy and completeness of the certificate:

    • Using an invalid, falsified, or incomplete CFS can lead to serious consequences. Including the rejection of the product’s importation, fines, or even criminal prosecution under Vietnamese law.

  • Compliance with current regulations:

    • Companies must stay updated with the latest regulations from the Ministry of Health and the medical device regulatory authorities in Vietnam regarding CFS requirements and related import procedures. Legal regulations may change over time, and non-compliance with current regulations can affect the company’s business operations.

  • Cooperation with authorities:

    • Importing companies should closely cooperate with the relevant authorities throughout the importation and distribution process of medical devices. This helps minimize risks and ensures that the products will be introduced to the market legally and safely.

5. Conclusion

The Certificate of Free Sale (CFS) is an indispensable element in the process of importing medical devices into Vietnam. It serves not only as legal proof of the product’s legitimacy. But also as evidence of the quality and safety of the medical devices when circulated in the market. Therefore, ensuring that the CFS meets all legal, technical, and language requirements. Is a prerequisite for a smooth importation process that complies with current regulations.

 

———————————————————————————————————————————————————————–

Contact

 

Contact Form

    Leave a Reply

    Your email address will not be published. Required fields are marked *

    Hotline: 0938.960.113
    SMS: 0938.960.113 Nhắn tin Facebook Zalo: 0938.960.113