Medical Devices

Dossier and Procedures for Obtaining Marketing Authorization (MA) for IVD Medical Devices of Class C and D with National Technical Regulations

In the context of international integration and the growing demand for quality assurance in the healthcare sector, the supervision and management of medical device circulation play a vital role. Specifically, for imported in vitro diagnostic (IVD) medical devices classified as Class C and D, technical and regulatory requirements are particularly stringent.

To legally and safely place products on the Vietnamese market, organizations and enterprises must complete the procedures for the initial registration for marketing authorization in accordance with applicable laws. The following article provides a detailed and comprehensive overview of this process, based on current legal instruments such as Decree No. 98/2021/ND-CP and Circular No. 19/2021/TT-BYT.

1. Legal Basis

The procedures for granting marketing authorization are implemented based on the following legal documents:

  • Decree No. 98/2021/ND-CP dated November 8, 2021, on the management of medical devices.

  • Circular No. 19/2021/TT-BYT issued by the Ministry of Health, detailing templates and dossier components.

2. Procedures for Obtaining Marketing Authorization

Step 1: Submission of Dossier
 Organizations and enterprises must submit an application dossier for marketing authorization to the Ministry of Health via one of the following portals:

 

Step 2: Appraisal and Issuance of MA Number
 Upon receipt of a complete and valid dossier, including proof of payment for the appraisal fee, the Ministry of Health will appraise and issue the MA number within 30 working days. If the application is denied, a written explanation will be provided stating the reasons.

Step 3: Supplementation or Amendment of Dossier (if necessary)
 If the dossier does not meet the requirements, the applicant must supplement the application according to the Ministry’s request. The authority will continue reviewing the amended documents. If, within 90 days from the first request, the applicant fails to supplement the dossier or the dossier still does not meet the requirements after five (05) revisions, the procedure must be restarted from the beginning.

Step 4: Disclosure of Information
 Within one (01) working day from the issuance of the MA number, the Ministry of Health is responsible for publicly disclosing information related to the medical device on the Medical Device Management Portal.

3. Format and Components of the Application Dossier

Format of Submission
 All dossiers must be submitted online via the Ministry of Health’s Public Service Portal or the Medical Device Management Portal.

Required Documents:

  • Application form for new MA issuance (Form No. 03.01 as per Circular No. 19/2021/TT-BYT).

  • Valid ISO 13485 quality management system certificate.

  • Letter of Authorization from the device owner to the registrant (except when the registrant is also the owner and is based in Vietnam).

  • Confirmation of warranty eligibility or documents proving that the device does not require warranty service.

  • Valid free sale certificate (at the time of submission).

  • Certificate of conformity with applicable Vietnamese National Technical Regulation (QCVN).

  • ASEAN Common Submission Dossier Template (CSDT) – mandatory for dossiers submitted from January 1, 2023.

  • Technical description, user manual in Vietnamese, and the proposed label for circulation in Vietnam.

4. Conditions for Granting Marketing Authorization

According to Article 25 of Decree No. 98/2021/ND-CP, entities applying for registration must meet the following conditions:

  • Be a business entity, cooperative, or household business established in Vietnam, or be authorized by the device owner.

  • Have a service center in Vietnam or a contract with a qualified warranty provider, except for single-use devices or those without warranty obligations as declared by the owner.

  • If the registrant is a representative office of a foreign entity, the device owner must ensure that the warranty service facility in Vietnam meets the legal requirements.

5. Processing Time and Fees

  • Processing Time: Maximum 60 days from the date of receipt of a complete and valid dossier.

  • Fee: VND 6,000,000 per dossier (appraisal fee for Class C and D medical devices), in accordance with the Ministry of Finance’s regulations.

Strict compliance with the marketing authorization procedures for imported IVD medical devices in Class C and D ensures legal conformity and enhances product safety and quality in the Vietnamese market. Organizations and businesses are advised to thoroughly understand applicable regulations, prepare complete documentation, and follow the required procedures to ensure a smooth and efficient appraisal and registration process.

For consultation regarding the registration of medical devices, health supplements, cosmetics, and functional foods in accordance with current regulations, please contact us at Hotline: 098.546.1894.