What are cases of exemption from first inspection before putting medical devices into service in Vietnam?

What are cases of exemption from first inspection before putting medical devices into service in Vietnam? (Internet image)

Regarding this issue, LawNet would like to answer as follows:

1. What is medical device?

According to Clause 1, Article 2 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:

(i) 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.

(ii) 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 in (i).

2. What are cases of exemption from first inspection before putting medical devices into service in Vietnam?

Specifically, in Article 57 of Decree 98/2021/ND-CP, a medical device shall be exempted from the first inspection before it is put into service in one of the following cases:

- The certificate of conformity for the medical device is available.

- The unregistered medical device is imported to serve scientific research or training in use, maintenance or repair of such medical device.

- The unregistered medical device is imported to serve the importer’s personal treatment of illness or charitable medical examination and treatment or special diagnostic purposes.

- The unregistered medical device is imported for display at a trade fair, exhibition or product launch event.

3. Instruction on handling of unqualified medical devices in Vietnam

The handling of unqualified medical devices is regulated as follows:

(1) In case the result of the inspection conducted before putting the medical device into service is not satisfactory:

- Health facilities shall not receive and use that medical device;

- The inspecting organization shall send a written notice of unsatisfactory inspection result to the Ministry of Health;

- If 03 medical devices of the same batch fail to meet the safety and function inspection requirements, the Ministry of Health shall request the registration number holders in writing to send reports on the quantity of medical devices being placed on the market and those being used in health facilities.

Registration number holders’ reports and the unsatisfactory inspection result are the basis for the Ministry of Health to decide whether to carry out a reinspection, the quantity of medical devices that have to undergo reinspection, or suspend the use of such medical devices.

The Ministry of Health shall, based on the reinspection result, decide whether to carry out another reinspection, the quantity of medical devices that have to undergo another reinspection, or request the registration number holders to recall the entire batch of medical devices.

In case 03 batches of medical devices are recalled during the validity of the registration number, the registration number of the medical device shall be revoked. Medical devices that have been used by health facilities before the issuance of the decision to revoke the registration number may be used if they pass the inspection.

(2) In case the result of a periodic inspection or post-overhaul inspection is not satisfactory:

- Health facilities must stop using that medical device;

- The marking of the previous inspection result shall be removed;

- Health facilities shall cooperate with the registration number holder in implementing corrective measures and carrying out a reinspection;

- Only the medical device that passes the reinspection may be used.

(Article 58 of Decree 98/2021/ND-CP)

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