On 30 December 2023, the Authority of Vietnam issued Decree 96/2023/NĐ-CP detailing several articles of the Law on Medical Examination and Treatment. Furthermore, Article 147 of this Decree has amended and supplemented some articles of Decree 98/2021/NĐ-CP regarding “Medical Device Management.”
The highlighted amendments and supplementations to the articles of Decree 98/2021/ND-CP are as follows:
1.Clause 8 to Clause 18 of Article 147 Decree 96/2023/NĐ-CP amended and supplemented Chapter IV “Clinical study on medical devices” in Decree 98/2021/NĐ-CP on Medical Devices Management.
2.Clause 19 of Article 147 Decree 96/2023/ND-CP amended and supplemented Article 30 of Decree No. 98/2021/ND-CP by adding the requirement for the Certificate of Clinical Test Results from a competent Authority for medical devices subjected to clinical testing into the registration dossier of Class C and Class D medical devices. However, this regulation will only come into effect on 01 January 2026.
3.Prioritization in the processing of registration dossiers for the circulation of medical devices that fall under one of the following categories:
- Medical devices that are manufactured in Vietnam.
- Medical devices having import license application submitted before 01 January 2022 but have not yet been granted and having circulation application submitted.
- Chemicals, products with the sole purpose of disinfecting medical equipment.
- Medical devices with new technologies which have been approved by the Ministry of Health but have not yet been issued a registration number.
- Medical devices having changes in the information such as change in importer or license holder, change in the name of the manufacturing site or product owner (with no changes in the address of the manufacturing site or product owner) but without changes in the product code or category as stated in the granted import license or registration license or valid certificate of circulation.
- Medical devices with no changes in category but having changes in the product code due to discontinuation of the previous product code in one of the following documents: import license, registration number, or valid certificate of circulation.
- Medical device applications have been requested to supplement or rejected due to an update on the validity of LOA, ISO 13485, MA (Marketing Authorization).
- Medical device applications have been requested to supplement or rejected due to change or supplement the name of the medical device.
4. Prioritization during review process of registration dossiers for the circulation of medical devices will be carried out as follows:
- The Registrants shall apply for a form to prioritize processing, including sufficient information regarding the submitted application number on the DMEC website.
- The Registrants shall provide supporting documentation corresponding to the cases eligible for prioritized processing.
- The Ministry of Health will examine the request and allow for prioritized processing of the registration dossiers for the circulation of the medical device within 10 working days from the date of receiving the requesting applicant and accompanying documents.
- In cases where prioritized processing is not permitted, MOH will provide a written response stating the reasons for the decision.
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