Avoid Rejection: Check Your CFS for Medical Device Registration in Vietnam

Introduction

The Certificate of Free Sale (CFS) serves as official proof that your medical device is legally marketed and sold in its country of origin. In Vietnam, however, this document must meet strict criteria, both in content and legal status. If your CFS fails to comply, your entire registration dossier could be rejected, causing significant delays.

In this article, Green NRJ will help you learn what a valid CFS must include, how to properly check a CFS for medical device registration, and the most common mistakes that should be avoided.

What Are the CFS Requirements for Medical Devices in Vietnam?

To be accepted during medical device registration in Vietnam, a valid CFS for medical device registration must include the following information:

These are the minimum medical device CFS document requirements recognized under the Certificate of Free Sale Vietnam regulations.

How to Check CFS for Medical Device Registration: The Essential Checklist

To avoid delays or rejections during the registration process, it’s essential to understand how to check CFS for medical device registration properly. Use this updated CFS checklist for medical device registration in Vietnam to ensure full compliance:

Overlooking any of these points can result in rejection. Understanding why CFS is rejected in Vietnam often comes down to minor details. Proper document review is crucial for securing CFS approval for imported medical devices.

These issues often only become apparent during importing Class C and D medical devices into Vietnam, when customs authorities re-check the dossier and identify inconsistencies that can lead to delays or rejection.

Common Certificate of Free Sale (CFS) Mistakes in Medical Device Registration in Vietnam

1. Missing or Incorrect Product Information on CFS (Product Name, Model, Domestic Market Availability)

One of the most fundamental yet highly common mistakes in the Certificate of Free Sale (CFS) for medical device registration in Vietnam is missing or incorrect product information, including product name, model, and confirmation of domestic market availability. According to Clause 3, Article 10 of Decree 69/2018/ND-CP and Vietnam’s medical device regulations, particularly Decree 98/2021/ND-CP, the CFS must clearly state that the product is manufactured and permitted for free sale in the domestic market of the manufacturing country or the country issuing the certificate. The standard wording should indicate that the product is “freely sold in domestic and overseas markets.”

In practice, many dossiers are rejected because the CFS only states that the product is “permitted for export” without confirming domestic circulation, an issue commonly seen with CFS documents issued in Korea. In addition, missing model names or inconsistencies in the product name compared to other documents within the medical device declaration or circulation dossier can also lead to non-acceptance, as all information provided in the CFS must be fully consistent with the rest of the registration documentation.

2. Incorrect or Missing Seal/Stamp of the Issuing Authority: A Decisive Factor for CFS Validity

The validity of the seal and the authority of the issuing body on the Certificate of Free Sale (CFS) is not merely a formality; it is a crucial element that confirms the legal value of the document. An incorrect or missing seal can immediately lead to the rejection of your medical device registration dossier.

To ensure the origin and quality of imported medical devices, the Ministry of Health of Vietnam has specific regulations regarding the recognition of foreign CFS issuing authorities.

Example with Chinese CFS: According to the provisions of Decree 98/2021/ND-CP, the Vietnamese Ministry of Health only accepts two specific types of seals on a CFS from China:

• Seal of Provincial/City Medical Products Administrations: These are local-level regulatory bodies responsible for licensing and managing medical products within their respective provinces or centrally-governed cities in China.
  • Illustrative example: A CFS for a medical device manufactured in Shanghai might bear the seal and signature of the “Shanghai Medical Products Administration.” This seal, clearly showing the agency’s name and often an official emblem, will be recognized as valid by the Vietnamese Ministry of Health. This level of administration is closely aligned with the manufacturer, ensuring the authenticity of product information in that specific locality.
• Seal of the National Medical Products Administration (NMPA): This is the highest regulatory authority for pharmaceuticals and medical devices in China. A CFS issued or certified by the NMPA will always be accepted, as it represents the central authority with national jurisdiction.
  • Illustrative example: A CFS for a product with nationwide circulation or requiring the highest level of confirmation might bear the seal of the “National Medical Products Administration (NMPA).” The NMPA’s seal signifies authenticity at a federal level, widely recognized internationally.

Examples of Seals/Authorities Not Accepted in Vietnam: In some cases, even if an authority appears to be a government body or a reputable organization in its home country, it may not be accepted by the Vietnamese Ministry of Health for the purpose of issuing a CFS:

• CFS from Japan issued by OMET A (Overseas Medical Equipment & Technology Association): OMET A is a reputable association of Japanese medical device manufacturers and exporters. However, under current Vietnamese regulations, OMET A has not been recognized by the Vietnamese Ministry of Health as an official CFS issuing authority. This might be because the organization is an association rather than a state management agency directly under the Japanese government. Therefore, a CFS bearing OMET A’s seal will be rejected when submitted in Vietnam.
  • Illustrative example: If you are importing a medical device from Japan and your CFS has OMET A’s seal, you will need to request the manufacturer to provide a CFS issued by a competent state management agency equivalent to the Ministry of Health of Japan, such as the Ministry of Health, Labour and Welfare (MHLW) of Japan, or a pharmaceutical and medical device regulatory body directly under MHLW.
• CFS issued by the China Chamber of Commerce for Import and Export of Medicines & Health Products: Similar to OMET A, the Chamber of Commerce is a trade promotion organization, not a state management agency with the authority to license the circulation of medical products. Although it is an important organization in the trade sector, a CFS bearing its seal will not be accepted by the Vietnamese Ministry of Health for medical device registration purposes.
  • Illustrative example: A Vietnamese importer receiving a CFS from a Chinese partner with the “China Chamber of Commerce…” stamp will certainly have their dossier rejected. The importer must request a CFS with the seal of the NMPA or a Provincial Medical Products Administration as mentioned above.

Important Note: To avoid risks and unnecessary dossier amendments, importing businesses should proactively work with their manufacturers or suppliers abroad. Ensure that the CFS is issued by the correct competent authority recognized by the Vietnamese Ministry of Health and bears a clear, valid seal. This will significantly save time and costs throughout the entire dossier preparation and submission process.

3. Lack of Consular Legalization for the CFS

A CFS without consular legalization is considered legally invalid in Vietnam and will be rejected. This step is mandatory.

What is Consular Legalization? It is the official process where the Vietnamese Embassy or Consulate in the country that issued the CFS verifies the authenticity of the seal, the signature, and the signatory’s title on the document. This verification confirms to the Vietnamese authorities that the CFS is a legitimate document issued by a competent authority in the country of origin.

4. Expired Certificate of Free Sale (CFS)

Using an expired CFS is a common and critical error that leads to automatic rejection. The CFS must be valid at the time of dossier submission to the Vietnamese authorities.

Key Validity Rule: According to regulations, a CFS is generally considered valid for 24 months from its date of issuance, unless a shorter validity period is explicitly stated on the certificate itself. Always check the issuance and expiry dates before submission.

5. CFS Does Not Clearly Show the Relationship Between Manufacturer and Medical Device Owner

One of the complex errors that often causes difficulties for businesses, especially with OEM (Original Equipment Manufacturer) or Private Label production models, is when the Certificate of Free Sale (CFS) does not clearly demonstrate the legal relationship between the actual manufacturer and the legal owner of the medical device. Vietnamese regulatory authorities demand this transparency to ensure product traceability and legal accountability.

Common Scenarios and Regulatory Requirements:

There are two primary scenarios that frequently lead to dossier rejection:

1. CFS Only Shows Manufacturer’s Information but is Issued to a Different Medical Device Owner:
   • Problem: In this case, the CFS only lists the name and address of the manufacturing plant (the physical entity that produces the product). However, if the name of the “medical device owner” (i.e., the brand owner, or another company holding distribution rights for that product) differs from the manufacturer’s name on the CFS, then this CFS will not be accepted.
   • Reason: The Vietnamese Ministry of Health requires a document proving the legal ownership or distribution rights of the entity named on the CFS for the product. An inconsistency between the manufacturing plant and the owner on the CFS creates a legal and traceability gap.
2. CFS Only Shows the Medical Device Owner’s Name but Not the Manufacturer (Typical for OEM/Private Label):
   • Problem: This is a very common situation with OEM products, where a company orders production from another factory, and the product is sold under the ordering company’s brand. The CFS might only list the name of the brand-owning company (the owner) without direct mention of the actual manufacturing plant.
   • Mandatory Requirement: In this scenario, the submitting business must provide an Explanation Letter of Relationship. This letter needs to:
     • Clearly explain the relationship: Detail which factory manufactures the product for the owner, and the owner’s rights regarding the product (e.g., OEM contract, exclusive distribution agreement, trademark use agreement).
     • Be issued by the manufacturer or the owner: Depending on the specific agreement and regulations.
     • Require mandatory Consular Legalization: Similar to the CFS, this explanation letter must also undergo consular legalization to ensure its legal validity and value in Vietnam. Failure to complete this step will result in the letter being rejected.

Understanding and avoiding these common CFS errors will help businesses expedite the medical device registration and circulation process in Vietnam, minimizing the risk of application rejection. Always thoroughly check all information on your CFS before submitting your dossier.

Conclusion

Your CFS for medical device registration is more than just a formality, it’s a critical compliance document. Errors like wrong seals, missing product names, or expired documents can halt your market entry and waste months of effort.

Don’t take chances. Review your CFS against Vietnam’s requirements, get it properly legalized, and ensure all details are aligned with your registration dossier.

Need help reviewing or preparing your CFS? Contact Green NRJ today, we can support you with professional document verification and end-to-end regulatory solutions. Let us help you register faster and smarter.