Medical device registration in Vietnam
The Department of Medical Equipment and Health Works (DMEHW), under the Ministry of Health (MOH), is the regulatory body that governs the registration and approval of all medical devices in Vietnam. In 2016, the MOH released decrees 36 and 39 dictating that the DMEHW would be in charge of all device registrations.
The first step toward regulatory compliance in Vietnam for all medical devices is a classification assessment performed by a certified Classification Agent. The process takes around 3 days and fees vary by device risk class (about US$ 25 for Class A, US$ 50 for Class B, and US$ 75 for Class C or D). Then the regulatory pathway will vary depending on classification and devices category, until the new Rules are fully transitioned on January 1, 2022.
The first step toward regulatory compliance in Vietnam for all medical devices is a classification assessment performed by a certified Classification Agent. The process takes around 3 days and fees vary by device risk class (about US$ 25 for Class A, US$ 50 for Class B, and US$ 75 for Class C or D). Then the regulatory pathway will vary depending on classification and devices category, until the new Rules are fully transitioned on January 1, 2022.
Class A devices are subject to a Notification process. The application is comprised of administrative documents only (no technical file). Documentation can be submitted in Vietnamese or English. Following documents such as the Letter of Authorization and Certificate of Free Sales (Registration for class A, add CFS in submitted dossier from 2019) are must.
Class B, C and D devices must obtain a Registration Certificate (Market Authorization (MA) License). Technical data demonstrating device conformity assessment have to be submitted in ASEAN MDD Common Dossier Submission Template (CDST) format. Quality Management system must comply with ISO 13485:2016. . Once issued an MA License is valid for 5 years.
How to register for your medical devicein Vietnam
Appoint a local authorized representative in Vietnam
Submit application for importation. This includes: description of purpose for importation, quality certificate, and Certificate of Free Sale (FSC), and technical requirements (manual, description, list of other countries in which device is approved, safety information)
Submit application dossier. This includes: application form, proof of compliance with ISO 13485, instruction manuals (original and in vietnamese), and Certificate of Free Sale (FSC)
Titansmedical can help you with medical device or IVD registration, act as your Authorized representative and support you with distributor identification and importation.
