Tiếng Việt
To be legally marketed, a medical device must be issued a registration number by Vietnam’s health regulatory authority. So, what is a medical device registration number, and how can it be looked up? Let’s explore this topic with Medgate in the following article.
What is a Medical Device Registration Number?
According to Article 21 of Decree No. 98/2021/ND-CP on the Management of Medical Equipment, the registration number of a medical device is classified as follows:
a) A declaration of applied standards number for medical devices classified as class A and B;
b) A registration certificate number for medical devices classified as class C and D.
The purpose of registering and issuing a medical device registration number is to ensure the quality, safety, and effective usage of medical devices. Additionally, registration helps regulatory authorities obtain comprehensive, accurate, and timely information on the technical specifications, intended use, and potential risks associated with medical devices, thereby ensuring traceability.
Validity of the Registration Number: The medical device registration number is valid indefinitely, except in cases where it is issued under emergency provisions.
How to Look Up a Medical Device Registration Number via the Public Service System
Step 1: Access the Online Public Service System for Medical Device Management
Visit the Ministry of Health’s official portal for medical device management at the following link: https://imda.moh.gov.vn. This is the official platform where the Ministry of Health publicly provides information on medical devices to organizations and individuals in need.
Step 2: Select the “Public Service Results” Section
On the system’s main interface, click on the “Public Service Results” section in the navigation menu.
Step 3: Choose “Advanced Search”
In the search interface, select “Advanced Search.” Enter the necessary details such as the medical device name, company name, and declaration period to narrow down the search, making it quicker and more precise.
Step 4: Click “Search” and Review the Results
For the most specific search results, fill in as many requested fields as possible. Once completed, click on the “Search” button to receive the retrieved results.
The search results table displays full details, including the declaration number, declaration date, company name, and the status of the registration number. Click on the cloud icon in the declaration document column to view additional details about the medical device and the approved dossier components.
A sample of information form for declaration of applied standards for class A and B medical devices
In addition, medical device registration information can also be looked up through the manufacturer’s or distributor’s official website or product labeling.
In conclusion, accurately looking up a medical device registration number allows users to verify the legal compliance of medical devices quickly and reliably.
For more information on medical device registration and the issuance process at MEDGATE, please contact our Hotline: 098.546.1894 or Email: medgatevn@gmail.com for consultation on documentation services, procedural guidance, registration fees, and medical device advertising regulations.