Can a Medical Device Registration Number be Authorized for Import in Vietnam 2025 – Successful Compliance

Introduction

Medical Device Registration number be authorized for import is a common compliance question many companies face when entering the Vietnam market. Many clients of Green NRJ who already hold medical devices, often ask: “Can we authorize other companies to use these registrations to import goods into Vietnam? If yes, what procedures must be followed—and if not, what are the restrictions?” The answer is yes, but only if the import follows the official authorization process under Decree 98/2021/NĐ-CP.

To stay compliant in 2025, businesses must understand how medical device registration in Vietnam works, how an authorization letter is granted, and what responsibilities authorized importers must meet regarding documentation, storage, and distribution. This article provides a practical guide to avoid penalties and ensure smooth market entry.

Understanding Medical Device Registration in Vietnam

Before any medical device can be imported, it must be reviewed and approved by the Ministry of Health. Under Decree 98/2021/NĐ-CP, the pathway for medical device registration in Vietnam depends on the device’s classification:

• Class A & B → These are low to medium-risk devices. They are approved through a Declaration of Applied Standards. Once the declaration is accepted and published, the Ministry of Health issues a circulation number confirming the device is legally registered.

• Class C & D → These are medium to high-risk devices. They require a Marketing Authorization (MA) number, also known as a registration number in Vietnam. The MA is granted only after submission and approval of a complete registration dossier in line with ASEAN Common Submission Dossier Template (CSDT) requirements.

The organization that obtains either the declaration or the MA is called the registration holder. Without a valid registration number, medical devices cannot be imported, distributed, or sold in the Vietnamese market.

How Authorization of Medical Device Registration Numbers Works

According to Clause 2, Article 47 of Decree 98/2021/NĐ-CP, importation of medical devices into Vietnam is only permitted under one of the following conditions:

1. The importer is the registration holder – the enterprise that has been granted a valid circulation number (for Class A and B devices) or a marketing authorization number (for Class C and D devices).

2. The importer has been authorized in writing by the registration holder – holding a formal authorization letter issued by the registration holder.

For such authorization to take effect:

• The registration holder must notify the Ministry of Health and provide the authorization letter.

• The authorized importer must submit this letter, together with the registration details, to the customs authority during clearance procedures.

 Without compliance with these requirements, the importation will not be recognized as lawful under Vietnamese medical device regulations.

Duties of Authorized Medical Device Importers

Authorization enables import—but it also incurs strict legal obligations under Decree 98/2021:

1. Facilities and Logistics Compliance
   The authorized importer must have access to a warehouse and transportation suitable for the type of medical devices, including proper storage conditions. If the devices contain narcotics or precursors, an inventory monitoring system is required.
2. Traceability Assurance
   The importer must ensure traceability of all medical devices throughout the supply chain, as mandated by Article 3.
3. Post-market Trace Documentation
   Although primarily the registration holder is responsible for maintaining post-market traceability documents, the authorized importer must cooperate in ensuring these records are accessible during customs or regulatory inspections.

Other Practical Notes

1. One approval, one holder
   Each marketing authorization or declaration number is issued to a single registration holder. However, that holder may grant written authorizations to multiple importers under Clause 2, Article 47 of Decree 98/2021/NĐ-CP.
2. Expiry of approval
   When the registration number expires or is revoked, all related authorizations automatically lose effect, since they are legally dependent on the validity of the registration.
3. Validity and Revocation of Registration Numbers
   Under Decree 98/2021/NĐ-CP (as amended by Decree 07/2023/ND-CP), registration numbers for medical devices are generally valid indefinitely. However, if a registration number is revoked by the Ministry of Health, all related authorizations immediately lose effect because they are legally tied to the validity of the registration.

Conclusion

In 2025, medical device registration in Vietnam under Decree 98/2021/NĐ-CP remains a strict requirement. Importers who are not registration holders may only bring medical devices into Vietnam with a valid authorization letter officially filed with the Ministry of Health and submitted to customs. To ensure compliance, verify your registration number, obtain proper authorization, and follow storage and traceability obligations to avoid penalties or delays. For a complete overview of the entire registration process, see our main article: Medical Device Registration in Vietnam. For tailored guidance and full support in medical device registration and import procedures, contact Green NRJ today and secure a smooth market entry in Vietnam.