What are regulations on rules for inspection and calibration of medical devices in Vietnam?
Please ask, related to medical devices inspection and calibration in Vietnam. I don't know what principles to ensure? Looking forward to answering according to the latest regulations.
According to Article 55 of Decree 98/2021/ND-CP, the rules for inspection and calibration of medical devices in Vietnam are as follows:
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.
Best Regards!
