What are rights of health facilities for management and use of medical devices in Vietnam?
Please ask, according to the latest regulations, what are rights of health facilities for management and use of medical devices in Vietnam? Please advise.
What are rights of health facilities for management and use of medical devices in Vietnam?
According to Article 65 of Decree 98/2021/ND-CP stipulating rights and responsibilities of health facilities for management and use of medical devices, specifically:
1. Each health facility shall have the following rights:
a) Request the registration number holder or the warranty center recognized by the product owner to provide periodical maintenance of medical device during the warranty period;
b) Request the seller to provide technical documents of the medical device;
c) Receive the used medical devices to serve their scientific research and training in use and repair of medical devices.
2. Each health facility shall have the following responsibilities:
a) Use and operate the medical device according to instructions of the product owner;
b) Carry out periodical maintenance, inspection and calibration according to instructions of the product owner or as prescribed by law;
c) Participate in testing for and assessment of quality of medical devices;
d) Submit reports on defective medical devices and provide other information at the request of competent authorities.
Best Regards!
