In 2015, the Association of Southeast Asian Nations (ASEAN), which is comprised of 10 countries-Indonesia, Malaysia, Philippines, Singapore, Thailand, Vietnam, Brunei, Laos, Myanmar, and Cambodia, signed an agreement, formally called the ASEAN Medical Device Directive (AMDD), that aimed to harmonize medical device regulations in these member nations. An important element of the AMDD is the ASEAN Common Submission Dossier Template (CSDT), a collection of technical documents that allows a manufacturer to provide the same body of product registration submission to different authorities of the ASEAN Member States (AMS) thus reduces cost for manufacturers who wish to obtain device approval in any of the ten AMS.
In order to adapt the directive into regulating Vietnam’s medical device industry and ease the placement of medical devices into the Vietnam market, in May 2021, the Vietnamese Ministry of Health (MOH) published new guidance that was released as Decision No. 2426/QĐ-BYT. The guideline was constructed according to AMDD and with reference to the CSDT guidance of Singapore and Malaysia, that aims to provide guidance on the preparation of a product registration submission for both general medical devices class B, C, D as well as In Vitro Diagnostic (IVD) medical devices using ASEAN CSDT.
Elements of Vietnam CSDT includes:
1. Executive summary: an overview, commercial marketing history, intended uses and indications in its label, list of regulatory approval in GHTF countries, important safety and performance-related information.
2. Essential Principles checklist.
3. Device description: a complete description, intended use, indications, instructions of use, contraindications, warnings, precautions, potential adverse effects, alternative therapy, materials, other relevant technical characteristics.
4. Summary of design verification & validation documents: pre-clinical studies, pre-clinical studies for IVD, clinical evidence.
5. Device labeling: sample of labels on the device and its packaging, instructions for use.
6. Risk analysis: risk management report.
7. Manufacturer information: manufacturer info, manufacturing process.
The adoption of CSDT template for Class B, C, D devices registration will take effect immediately which is good news for manufacturers who already have the CSDT documentation in order.