On August 5th 2024, the Vietnam Ministry of Health (MoH) issued Decision No. 2302/QD-BYT regarding the promulgation of Guidelines for the Evaluation of Legal Documents for Registration Dossiers of Medical Device Class C and D. This decision replaces Decision No. 3007/QĐ-BYT dated November 3, 2022.
There are no changes to the legal documentation component for evaluation by the Authority in the registration dossier for medical device class C and D. The general principle is based on the provisions of Article 30 of Decree No. 98/2021/ND-CP, Clause 6 of Article 76 of Decree No. 98/2021/ND-CP as amended by Decree No. 07/2023/ND-CP, and Article 3 of Circular No. 05/2022/TT-BYT. Specifically, it includes the following components:
1. Application Form
2. The certification of quality management standards ISO 13485
3. Letter of Authorization
4. Certificate of Warranty Eligibility
5. Free Sale Certificate; or Marketing Authorization; or Free Sale Certificate and Import License/ Circulation Number/ Certificate of Registration.
6. CSDT or Result of appraisal of CSDT.
* Result of appraisal of CSDT is required to submit in the normal route application
- For non-IVD MD: Result of appraisal of CSDT is issued by National Institute of Vaccines and Biologicals or a unit designated by the MoH.
- For IVD MD: Result of appraisal of CSDT is issued by Institute of Medical Equipment and Works or a unit designated by the MoH.
7. The certificate of quality is required for the IVD medical device that includes reagent, calibrator or control material.
- For SARS-CoV 2: The certificate of quality shall be issued by one of the following institutes: National Institute of Vaccines and Biologicals, Central Institute for Hygiene and Epidemiology, Pasteur Institute in Ho Chi Minh City, Pasteur Institute in Nha Trang, and Tay Nguyen Institute for Hygiene and Epidemiology.
- For other IVD MD: The certificate of quality shall be issued by National Institute of Vaccines and Biologicals or a unit designated by the MoH.
8. Testing Certificate is required for the chemicals or preparations that are only used for disinfection of medical devices.
The principles for evaluating legal dossiers still follow Article 31 of Decree No. 98/2021/ND-CP. The evaluation process is specifically guided in Appendix 1 of Decision No. 2302/QD-BYT. By this decision, the MoH issued some new guidelines to improve the dossier appraisal process, as follows:
- While the registration dossier is being processed by the MoH, the registrant can send a written notice along with updated/supporting documents to the Infrastructure and Medical Device Administration (IMDA) for review. If appropriate, no additional requests or explanations will be made in the following cases:
- The registrant has changed administrative information that is inconsistent with the information searched through the Enterprise Tax Code at the portal of the General Department of Taxation – Ministry of Finance.
- The Letter of Authorization, Certificate of Quality Management Standards, Free Sale Certificate or Market Authorization expire during the Ministry of Health’s processing of the dossier.
In addition, Decision No. 2302/QD-BYT also included the finalization for the guidelines on naming rules for medical devices.
More details on Decision No. 2302/QD-BYT can be accessed here.
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