What are the conditions for placement of medical devices on the market? What is the registration number of a medical device in Vietnam?
What is a medical device according to the law?
Pursuant to Article 2 of Decree 98/2021/ND-CP, the definition of medical device is as follows:
“Medical device” means any instrument, implant, apparatus, material, in-vitro reagent or calibrator, or software that meets all of the following requirements:
- It is intended, by the product owner, to be used, whether alone or in combination, for human beings for the purpose of one or more of the following:
+ diagnosis, prevention, monitoring, treatment or alleviation of disease, or compensation for an injury or trauma;
+ investigation, replacement, modification or support of the anatomy or of a physiological process;
+ supporting or sustaining life;
+ control of conception,
+ disinfection of medical devices;
+ providing information serving diagnosis, monitoring or treatment through examination of specimens derived from the human body.
- The device does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but that may be assisted in its function by such means to serve the purposes mentioned above.
What are the conditions for placement of medical devices on the market? What is the registration number of a medical device in Vietnam? (Image from the Internet)
What are the conditions for placement of medical devices on the market?
The latest conditions for placement of medical devices on the market specified in Article 22 of Decree 98/2021/ND-CP (amended by Clause 2, Article 1 of Decree 07/2023/ND-CP) as follows:
A medical device may be placed on the market if it meets the following conditions:
- It has been granted registration number, marketing authorization number, certificate of registration or import license in accordance with regulations on management of medical devices or in the cases specified in Point d Clause 2 Article 76 of Decree 98/2021/ND-CP, except the following cases:
+ The medical device is liquidated as prescribed by laws;
+ The medical device reaches its expiry date;
+ The defect that is harmful to users’ health cannot be repaired;
+ The use of medical device is prohibited by a regulatory authority.
- Its label contains adequate information in accordance with regulations of law on labelling of goods;
- Instructions for use of the medical device are given in Vietnamese language;
- Information about warranty center, conditions and time for warranty, except disposable medical devices defined by the product owner or cases where there are documents proving that the medical device is not under warranty.
- If the import license is available as prescribed in Points a, b, c, d and dd Clause 1 Article 48 of Decree 98/2021/ND-CP, the satisfaction of the following condition is not required:
Information about warranty center, conditions and time for warranty, except disposable medical devices defined by the product owner or cases where there are documents proving that the medical device is not under warranty.
- If the information specified in Point c and Point d Clause 1 Article 22 of Decree 98/2021/ND-CP (amended by Clause 2, Article 1 of Decree 07/2023/ND-CP) is not provided upon the medical device itself, it must be provided in the form of electronic information for which instructions for search must be available on the label of the medical device.
What is the registration number of a medical device in Vietnam?
Pursuant to Article 21 of Decree 98/2021/ND-CP as amended by Clause 1, Article 1 of Decree 07/2023/ND-CP stipulating that registration number of a medical device in Vietnam is:
- The number of declaration of applied standards of Class-A or Class-B medical device;
- The number of certificate of registration of Class-C or Class-D medical device.
Registration number holder is the organization that declares applied standards for medical devices or is issued with the certificate of registration of medical devices in accordance with the provisions of Decree 98/2021/ND-CP.
- Validity of registration number: The medical device registration number shall be valid for indefinite term, except cases where a registration number is issued according to regulations on issuance of emergency use registration number for medical devices to serve epidemic prevention and control, and disaster recovery purposes. Based on the application for issuance of emergency use registration number for the medical device, the Minister of Health shall decide specific period validity of the issued registration number.
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