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Vietnam Medical Device Update: Recent Adjustments to the Application Document Requirements
Published on: June 7th, 2023
Vietnam has recently made significant amendments to its medical device registration process and technical documentation requirements. The Ministry of Health (MOH) issued Circular 10/2023/TT-BY on May 11, 2023, outlining the new guidelines for pre-market approval.
Key updates include the MOH amending the Technical Summary template for non-IVD medical devices and excluding class B medical device (Class A already exempt) from the Clinical Evaluation Report (CER) requirement beginning May 11, 2023.
Updated Technical Documentation Requirements
The MOH’s Circular 10/2023/TT-BY introduces revised technical documentation requirements for certain medical devices. Notably, the previous documentation list has been replaced, and manufacturers need to comply with the updated guidelines. One significant change is that class B medical devices no longer require the submission of Clinical Evaluation Reports (CER) starting from May 11, 2023. However, class C and D medical devices still need to submit CER as part of the registration process.
Document Requirements in Vietnam
Currently, the application requirements for medical device registration in Vietnam consist of administrative documents only, with no technical file required. Manufacturers can submit documentation in either Vietnamese or English until at least January 1, 2025 (as updated in March 2023). However, specific documents such as the Instructions for Use (IFU) and Technical Summary must be provided in Vietnamese, while documents like the Letter of Authorization need to be legalized/apostilled. Eventually, manufacturers will need to submit their applications in the Common Submission Dossier Template (CSDT) format, with implementation currently planned for January 1, 2025.
Registration Requirements for Different Device Classes
All Class A and B medical devices require registration, and the approval process usually takes around five days from submission.
On the other hand, only specific Class C and D medical devices require registration. The MOH’s Circular 05/2022 provides a comprehensive list of these devices, including X-ray imaging equipment, diagnostic ultrasound machines, radioisotope diagnostic equipment, and various other specialized medical devices. Class C/D devices not listed in Circular 05/2022 can be freely imported until December 31st, 2024. For a full list of Class C and D devices requiring registration at this time, please click here.
Validity of MA Licenses
Under the new Decree, MA Licenses for medical devices do not expire, providing manufacturers with long-term validity and stability for their registered products in Vietnam.
While the review of Class C and D applications continue to be delayed, the Vietnamese MOH has implemented important updates to its medical device registration requirements and technical documentation guidelines. Manufacturers should familiarize themselves with these changes to ensure compliance with the new regulations. Adhering to the revised document requirements and understanding the specific device classes that necessitate registration will help streamline the approval process and facilitate market access in Vietnam.
Come Grow With Us
Please contact us for more information on the medical device registration process in Vietnam. Asia Actual has an office in Ho Chi Minh City staffed by experienced, bilingual regulatory and commercial professionals to address questions or provide support.
Asia Actual is a regulatory consulting company focused on helping manufacturers grow sales in challenging Asian markets through registration, independent license holding, direct fulfillment, and a variety of sales channel support services.