VietNam’s MoH Updates Class C and D Application Requirements

Vietnam’s application requirements have been changed. Per Decree 07/2022, the application requirements for all new Class C and D applications submitted to the Vietnamese Ministry of Health (MoH) will need to be in ASEAN Common Submission Dossier Template (CSDT) format, with the addition of a Vietnamese IFU. Furthermore, the regulation states that the CSDT documents won’t need to be reviewed if the product has been approved by a Reference country and can provide the Certificate of Free Sale (CFS), or an equivalent. CSDT documentation not approved in a Reference country will be reviewed by a designated evaluation organization and will require additional time to be approved. Labeling will also need to be in Vietnamese which a local partner, like Asia Actual, can easily assist with.

Application Requirements and Update to the Review Process

As outlined in the primary medical device regulations, Decree 07/2022, Class C and D applications should be submitted in CSDT format beginning January 1, 2024. This represents a shift from the previous requirements where a more limited list of documents was required to be submitted. However, these changes should make submission easier for manufacturers that have already compiled their CSDT documentation. That being said, the Vietnamese MoH does still require the IFU be translated to Vietnamese.

While both scenarios will still need to wait in the currently very long line of applications, products with CSDT and a CFS/CFG from a Reference country can be expected to be approved quickly. The two application scenarios currently available are as follows:

1. Exemption from Evaluation: Products approved by at least 1 Reference country, including the US (FDA), Australia (TGA), Canada, Japan, EU members, England, Switzerland, China (NMPA), and Korea (MFDS), are exempt from CSDT evaluation. Here, the MoH recognizes the credibility of evaluations conducted by these reputable regulatory bodies.
2. CSDT Evaluation Requirement: For products without pre-existing approvals from the specified reference countries, the CSDT documentation must undergo evaluation before submission. This ensures a thorough and standardized assessment of the clinical data supporting the medical device application.

To date, the MoH has only released draft CSDT guidance which can be found here. Manufacturers and their local partners should monitor new guidance to ensure applications are submitted in accordance with the latest guidance. Asia Actual will update this article as more relevant guidance is released.

Appointment of Evaluation Organizations

The Ministry of Health, through Decision 04/QD-BYT issued on January 2, 2024, has appointed two key organizations for evaluating CSDT applications that are not already approved by a Reference country:

1. Non-IVD Medical Devices: The Institute of Medical Device and Constructions is designated as the evaluating body. Manufacturers can find more information on their official website: nimec.gov.vn
2. IVD Medical Devices: The National Institute for Control of Vaccine & Biological is tasked with evaluating In Vitro Diagnostic (IVD) medical devices. Further details can be obtained from their website: nicvb.org.vn

While the issuance of Decision 04/QD-BYT marks a significant step, it does not provide specific details regarding the evaluation process, timeline, or associated costs for CSDT evaluations. Stakeholders will need to await further guidance from the Ministry of Health to navigate this crucial aspect of the regulatory process.

In regard to CSDT content, Vietnam MOH have not issued official guidance for CSDT yet. We just have draft version until now (pdf). Will keep you posted.