Chương VII Nghị định 98/2021/NĐ-CP: Dịch vụ trang thiết bị y tế

Chapter VII

MEDICAL DEVICE-RELATED SERVICES

Section 1. MEDICAL DEVICE TECHNICAL CONSULTING

Article 53. Eligibility requirements to provide medical device technical consulting

1. Consulting on listing and formulation of technical configuration and functions of medical devices must be provided by individuals who have certificates of completion of training course in technical consulting on medical devices.

2. An individual who provides medical device technical consulting is required to:

a) have a bachelor’s degree, or higher, in technology, medicine or pharmacy;

b) have at least 05 years’ experience of working in medical device technology in health facilities;

c) have been examined and recognized by the training institution to be capable of providing medical device technical consulting according to the training program issued by the Ministry of Health.

3. A consultant shall only provide medical device technical consulting after the Ministry of Health publishes his/her information and application for declaration of eligibility to provide medical device technical consulting as prescribed in Point b Clause 2 Article 54 of this Decree.

Article 54. Application and procedures for declaration of eligibility to provide medical device technical consulting

1. An application for declaration of eligibility to provide medical device technical consulting consists of:

a) The application form for declaration of eligibility to provide medical device technical consulting;

b) Certified true copies of qualifications/certificates as prescribed in Point a and Point c Clause 2 Article 53 of this Decree;

c) Certificate of working period.

2. Procedures for declaration of eligibility to provide medical device technical consulting:

a) Before providing medical device technical consulting, the applicant shall send an application for declaration of eligibility to provide medical device technical consulting to the Ministry of Health.

b) After receiving the application (including application fee receipt as prescribed by the Ministry of Finance), the Ministry of Health shall publish on the Portal on management of medical devices all information about and application for declaration of eligibility to provide medical device technical consulting.

c) During its operation, the consultant shall prepare a notice of changes which is accompanied by supporting documents for such changes, and update such documents to his/her application for declaration of eligibility to provide medical device technical consulting published on the Portal on management of medical devices within 03 working days from the occurrence of such changes.

Section 2. INSPECTION AND CALIBRATION OF MEDICAL DEVICES

Article 55. Rules for inspection and calibration of medical devices

1. Medical devices included in the Minister of Health’s list shall undergo safety and function inspection before use (except for the cases in Article 57 of this Decree), periodically and after overhaul. Inspection of medical devices that are measuring devices or radiation equipment shall be carried out in accordance with Clause 2 of this Article.

2. Medical devices that are measuring devices or radiation equipment shall undergo inspection and calibration in accordance with regulations of laws on measurement and atomic energy.

Article 56. Requirements for provision of medical device inspection services

Facilities and personnel requirements, preparation and submission of application for certificate of registration of medical device inspection services, issuance, revision, re-issuance and revocation of certificate of registration of medical device inspection services are the same as those for provision of conformity assessment services.

Each inspection process registered must be handled by at least 02 inspectors who have certificates of completion of training program in such process.

Article 57. Exemption from first inspection before putting medical devices into service

A medical device shall be exempted from the first inspection before it is put into service in one of the following cases:

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

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

3. 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.

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

Article 58. Handling of unqualified medical devices

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

a) Health facilities shall not receive and use that medical device;

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

c) 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:

a) Health facilities must stop using that medical device;

b) The marking of the previous inspection result shall be removed;

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

d) Only the medical device that passes the reinspection may be used.