Decision 2302/QD-BYT: Vietnam’s Updated Guidance on Legal Dossier Appraisal for Medical Device Registration
On 5 August 2024, Vietnam’s Ministry of Health (MOH) issued Decision No. 2302/QD-BYT, promulgating updated guidance on the appraisal of legal dossiers submitted as part of medical device registration (circulation number/”số lưu hành” applications). The Decision supersedes Decision 3007/QD-BYT dated 3 November 2022 and introduces several changes that manufacturers, importers, and authorized representatives should factor into their regulatory submission strategy for the Vietnamese market.
This article summarizes the core requirements of Decision 2302/QD-BYT — from legal dossier composition and appraisal principles to the naming and labeling conventions that most frequently cause dossiers to be rejected or delayed.
What Is Decision 2302/QD-BYT?
Decision 2302/QD-BYT was signed by Deputy Minister of Health Do Xuan Tuyen and sets out the technical guidance used by appraisal experts when reviewing the legal (administrative/regulatory) component of a medical device registration dossier in Vietnam. It is grounded in the existing legal framework governing medical device management, principally:
- Decree 98/2021/ND-CP on medical device management (as amended by Decree 07/2023/ND-CP)
- Decree 96/2023/ND-CP, detailing certain provisions of the Law on Medical Examination and Treatment
- Circular 05/2022/TT-BYT and Circular 19/2021/TT-BYT (as amended by Circular 10/2023/TT-BYT)
- The appraisal expert rosters designated under Decision 981/QD-BYT and Decision 1842/QD-BYT
Effective date: the Decision took effect immediately upon signing (5 August 2024), and Decision 3007/QD-BYT ceased to have legal effect from that same date.
Legal Dossier Components Under Decision 2302/QD-BYT
Core documentation required for all applications
Under Article 1 of the guidance, every medical device registration dossier must, at minimum, include:
- A formal application letter requesting a new circulation number
- A valid ISO 13485 quality management system certificate, current as of the submission date
- A valid authorization letter (power of attorney) from the device owner to the registering establishment — not required where a Vietnamese enterprise, cooperative, or business household is itself the device owner
- A warranty confirmation certificate issued by the device owner — waived for single-use devices or where documentation confirms no warranty policy applies
- A valid free-sale certificate / marketing authorization (“Giấy lưu hành”), current as of submission, for imported devices
Additional documentation by application category
Decision 2302/QD-BYT sets out supplementary requirements depending on the specific registration pathway:
| Registration Category | Additional Required Documentation |
|---|---|
| Devices subject to a corresponding national technical regulation (QCVN) | Valid certificate of conformity |
| Devices classified as measuring instruments requiring pattern/type approval | Valid pattern approval decision |
| Expedited (fast-track) registration | Marketing authorization from a reference country, or an import license/circulation number/registration certificate as applicable |
| Emergency-use registration | Emergency-use authorization or permit for imported devices; technology transfer or contract manufacturing agreement (where applicable); quality inspection/assessment certificate in certain cases |
| In vitro diagnostic (IVD) devices under fast-track pathway | Additional local quality assessment certificate issued by a competent Vietnamese authority, unless the product already holds a CFS/MA from a reference country and falls under List A or B, Annex II of the EU IVD Directive |
| Applications submitted on or after 1 January 2024 (general devices) | Mandatory CSDT (Common Submission Dossier Template, per ASEAN requirements) appraisal result, issued by an MOH-designated appraisal body |
A key change from Decision 3007/QD-BYT: the ASEAN CSDT appraisal result is now a mandatory dossier component for applications filed from 1 January 2024 onward, rather than applying only to a narrower set of product categories as under the previous guidance.
Appraisal Principles and Competent Authorities
Decision 2302/QD-BYT clarifies which institutions are authorized to issue key supporting certificates and appraisal outputs:
- Local quality assessment certificate for SARS-CoV-2 IVD devices: issued by one of the following: the National Institute for Control of Vaccines and Biologicals (NICVB), National Institute of Hygiene and Epidemiology (NIHE), Pasteur Institute Ho Chi Minh City, Pasteur Institute Nha Trang, or the Tay Nguyen Institute of Hygiene and Epidemiology.
- Local quality assessment certificate for other IVD devices: issued exclusively by NICVB.
- CSDT appraisal result for IVD devices: issued by NICVB or another MOH-designated body.
- CSDT appraisal result for general (non-IVD) medical devices: issued by the Institute of Medical Equipment and Works, or another MOH-designated body.
Detailed appraisal criteria are set out in Appendix I to the Decision, covering the format of the application letter, registrant information, legal representative details, and — critically — the rules for declaring device name, trade name, GMDN code, model/type, product code, and packaging specification.
Key Compliance Points for Dossier Preparation
Appendix I flags several recurring sources of dossier non-conformity that applicants should review carefully:
- Device (common) name must be stated in Vietnamese, in standard (non-capitalized) text; it may not consist of a trade name, brand name, product/model code, or a merged listing of multiple device names, and English terms should only be used where no reasonable Vietnamese equivalent exists (e.g., “Real-time PCR,” “Catheter”). The declared name must be consistent with the scope stated on the ISO 13485 certificate and the marketing authorization/free-sale certificate.
- Terms such as “and accompanying…”, “accessories,” “supplies,” or “chemicals/reagents” must not be appended to the device name.
- For applications registered under a Family / Kit / System / Cluster grouping structure, the device name must conform to the grouping and naming conventions in Appendix II (general devices) or Appendix III (IVD devices).
- Registrant and legal representative information must match tax-code lookup records at tracuunnt.gdt.gov.vn; any discrepancy arising from a subsequent change must be formally reported, with supporting documentation, to the Department of Medical Equipment and Health Works Infrastructure.
- All declared category/type, product code, and packaging specification data must align with the information on the marketing authorization certificate; where such information is absent from that certificate, the product label or technical documentation issued by the device owner governs.
The Decision also promulgates Appendix IV, listing List A and List B products under Annex II of the EU In Vitro Diagnostic Medical Devices Directive/Regulation — the key reference used to determine which IVD products are exempt from local Vietnamese quality assessment when a valid CFS or Market Authorization has already been obtained from a reference-country regulator.
Implementation Responsibility
Under Article 3, responsibility for implementing Decision 2302/QD-BYT rests with the MOH Chief of Office, the Director of the Department of Medical Equipment and Health Works Infrastructure, the appraisal and post-market surveillance experts designated under Decision 981/QD-BYT and Decision 1842/QD-BYT, and the heads of other relevant agencies, units, and individuals.
Frequently Asked Questions
When did Decision 2302/QD-BYT take effect? It took effect on its signing date, 5 August 2024.
Is Decision 3007/QD-BYT still valid? No. Decision 3007/QD-BYT (3 November 2022) was fully superseded and ceased to have effect as of the effective date of Decision 2302/QD-BYT.
What is the single most significant change from the prior guidance? The mandatory CSDT (ASEAN Common Submission Dossier Template) appraisal requirement for dossiers filed from 1 January 2024, combined with substantially more detailed naming, labeling, and product-code declaration rules across Appendices I–IV.
Conclusion
Decision 2302/QD-BYT is now the operative regulatory reference for legal dossier appraisal in Vietnam’s medical device registration process. Manufacturers and authorized representatives preparing new registration applications — or renewals — should map their dossier against the applicable category in Appendix I and confirm CSDT and quality-assessment certificate requirements early, as these are the most common causes of appraisal delays and dossier returns.
Disclaimer: This article is a summary for general informational purposes based on Decision 2302/QD-BYT dated 5 August 2024. Applicants should consult the original Vietnamese-language text and, where necessary, a qualified medical device regulatory affairs consultant before submitting a dossier to Vietnam’s Ministry of Health.
