Vietnam: DMEC Publishes Decision No.2302/QD-BYT - Guidelines for Evaluation of Legal Documents in Class C and D Medical Device Registration Dossiers

As published by the DMEC of MoH Vietnam on 5 August 2024, Decision No. 2302/QD-BYT will replace Decision No.3007/QD-BYT regarding promulgation guidelines for the appraisal of legal documents for medical device class C and D registration dossiers. Decision No. 2302 did not change the legal documentation requirements but introduced new guidelines to enhance dossier evaluation procedures.

Registrants were permitted to submit a written notice and supporting documents to the Infrastructure and Medical Device Administration (IMDA) while the registration dossier was being processed by the Ministry of Health (MoH). However, additional supporting documents were not required for specific cases, such as administrative information changes that differed from Ministry of Finance records, or the expiration of documents like the letter of authorization, certificate of quality management standards, free sale certificate, or market authorization during the dossier process.

The legal documentation component for evaluation by the MoH remains same as the following:

• Application Form

• Quality Management Standards Certificate (ISO 13485)

• Letter of Authorization

• Warrant Eligibility Certificate

• Free Sale Certificate; Marketing Authorization; Free Sale Certificate, and Import License/ Circulation No./ Certificate of Registration

• CSDT / CSDT Evaluation Result (submitted in normal route application)

• Certificate of Quality is required for the IVD medical device including reagents, calibrators, or control materials

• Certificate of Testing is required for chemicals or preparations used exclusively for the disinfection of medical devices

Source: Department of Medical Device and Constructions (DMEC)

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