Cases of cancellation of classification results of medical device in Vietnam

What is medical device?

Pursuant to the provisions of Decree 98/2021/ND-CP, 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.

Cases of cancellation of classification results of medical device in Vietnam​ (Internet image)

Cases of cancellation of classification results of medical device in Vietnam

Pursuant to the provisions of Clause 1, Article 6 of Decree 98/2021/ND-CP, classification results shall be cancelled in the following cases:

(1) The incorrect classification result reduces the level of risk of the medical device;

(2) The record of classification results is found fraudulent.

Procedures for classification results of medical device in Vietnam

Pursuant to Clause 2, Article 6 of Decree 98/2021/ND-CP, the procedures for classification results of medical device in Vietnam are as follows:

- Within 01 working day from the day on which a conclusion mentioned in Clause 1 of this Article is given, the Ministry of Health shall issue a decision to cancel classification result which request the classification body to implement remedial measures (if any) and remove the cancelled classification result from the Portal on management of medical devices.

The decision to cancel classification result shall be sent to the classification body, Provincial Departments of Health, General Department of Customs and border checkpoint customs authorities, and published on the Portal on management of medical devices.

- After receiving the decision to cancel classification result, the classification body shall cancel all classification results specified in the decision and implement remedial measures against its violations (if any).

- After receiving the decision to cancel classification result, the authority that has received the application for declaration of applied standards or application for registration number (hereinafter referred to as “application for registration number”) shall review the registration numbers issued, and follow procedures for revoking the registration numbers of medical devices that have been issued using classification results specified in the Ministry of Health’s decision to cancel classification results.

Mai Thanh Loi

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