“The CSDT conference was valuable for understanding the expectations of the MoH for future registration applications.”

David Vo
General Manager
Asia Actual VietNam

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Key Takeaways from VietNam’s CSDT Conference

Published on: July 12th, 2024

On June 28, 2024, The Vietnam Ministry of Health hosted a training session on how to prepare an ASEAN MDD Common Standard Technical Document (CSDT). In attendance were representatives from the Institute of Medical Equipment and Construction, the US ASEAN Business Council, international regulatory experts, and leading regional medical equipment manufacturers and traders.

Highlighting the Role of CSDT in VietNam

The focus of the conference was on the CSDT, a comprehensive technical document mandated by the Ministry of Health for the approval of Type C and D medical devices. Compliance with ASEAN regulations ensure not only improved product quality but also facilitates smoother import-export operations and enhances market access within the region. These regulations are pivotal in safeguarding consumer health by ensuring that all medical devices meet stringent safety and efficacy standards.

Key Sessions

The conference was structured into two main sessions aimed at guiding participants through the preparation of CSDT documents:
Session 1: Covered the preparation of CSDT documents for common medical devices.
Session 2: Focused on the preparation of CSDT documents for in vitro medical devices.
Participants were also provided access to conference materials via QR codes provided by the Ministry of Health, enabling easy retrieval of essential documentation.

Navigating the New Regulations

Transitioning from older standards, such as the “Document summarizing the technical description of medical equipment in Vietnamese,” to the more CSDT format is a big adjustment for medical device registration applicants. However, harmonization with regional standards will facilitate business across ASEAN markets. The conference served as a crucial platform for Vietnamese medical enterprises to stay updated on the latest regulatory changes. This knowledge equips them to comply with international standards, thereby fostering sustainable growth in the domestic healthcare sector and expanding their global footprint.

Asia Actual VietNam is positioned to make market entry as efficient as possible and free of any compliance worries, regardless of device class. Please contact us for support in VietNam.

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Asia Actual specializes in helping medical device manufacturers grow their sales in Asia with experienced, bi-lingual commercial and regulatory experts on the ground in each market.

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