Regulations on management and use of medical devices by State-owned health facilities in Vietnam
I have a question, please advise according to the latest document: What is implementation of management and use of medical devices by State-owned health facilities in Vietnam? Thankyou
What is implementation of management and use of medical devices by State-owned health facilities in Vietnam?
According to Article 64 of Decree 98/2021/ND-CP stipulating management and use of medical devices by State-owned health facilities, specifically:
In addition to the provisions of Article 63 of this Decree, State-owned health facilities shall comply with the following provisions:
1. Investment in, purchase, management and use of medical devices shall comply with regulations of law on management and use of public assets.
2. Use of domestically manufactured medical devices is encouraged.
For reference, Article 63 of Decree 98/2021/ND-CP prescribes rules for management and use of medical devices as follows:
1. Medical devices must be properly managed and used to ensure their functions as well as economical and effective use.
2. Medical devices shall be stored, maintained and used in accordance with the manufacturer's instructions, and must undergo quality in accordance with regulations of this Decree.
With regard to medical devices subject to strict occupational safety and health requirements, regulations of the Law on occupational safety and health must be strictly complied in addition to regulations on quality control laid down in this Decree.
3. Documents on medical devices must be adequately prepared, managed and retained; medical devices shall be sufficiently and punctually recorded according to their actual state and values in accordance with regulations of laws on accounting and statistics and other relevant laws; funding for performing tasks prescribed in Clause 2 of this Article must be ensured.
4. Health facilities shall bear inspection of regulatory authorities in charge of managing medical devices.
Best Regards!
