Conditions for placement of medical devices on the market in Vietnam

Conditions for placement of medical devices on the market in Vietnam (Internet image)

1. What is medical device?

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 above.

(Article 2 of Decree 98/2021/ND-CP)

2. Conditions for placement of medical devices on the market in Vietnam

According to Article 22 of Decree 98/2021/ND-CP and amended by Clause 2, Article 1 of Decree 07/2023/ND-CP, the conditions for placement of medical devices on the market in Vietnam include:

* A medical device may be placed on the market if it meets the following conditions:

- It has been granted registration number, circulation registration number, certificate of circulation registration or import license according to regulations on management of medical equipment or the case specified at Point d, Clause 2, Article 76 of the Decree 98/2021/ND-CP, except for the following cases:

+ Being liquidated in accordance with the law;

+ Expiry date of the product;

+ It is not possible to overcome the fault factors that adversely affect the user's health as prescribed in Clause 4, Article 34 of Decree 98/2021/ND-CP;

+ When the competent state agency does not allow the use.

- Having labels with full information according to current regulations of law on goods labels;

- There are instructions for the use of medical equipment in Vietnamese;

- There is information about warranty facilities, conditions and warranty period; except in the case of single-use medical equipment as specified by the owner of the medical equipment or with documents proving that there is no warranty.

In case an import license is obtained as prescribed at Points a, b, c, d and dd, Clause 1, Article 48 of Decree 98/2021/ND-CP, the following conditions are not required:

There is information about the warranty basis, warranty conditions, and period; except in the case of single-use medical equipment as specified by the owner of the medical equipment or with documents proving that there is no warranty.

- In case of information specified at Points c and d, Clause 1, Article 22 of Decree 98/2021/ND-CP (amended byDecree 07/2023/ND-CP), if medical equipment is not included, it must be provided in the form of electronic information and must clearly show instructions for information search on the label of the medical device.

3. Registration number of medical devices in Vietnam

- Registration number of a medical device 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 Class-A or Class-B medical device or that is granted certificate of registration of Class-C or Class-D medical device.

- 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.

(Article 21 of Decree 07/2023/ND-CPP)

>> CLICK HERE TO READ THIS ARTICLE IN VIETNAMESE