What are responsibilities of the holders of the registration numbers of medical devices in Vietnam?
Hello, our company specializes in importing and installing medical devices for hospitals and clinics to facilitate healthcare services. I have a question. What are responsibilities of the holders of the registration numbers of medical devices in Vietnam? Thank you!
What are responsibilities of the holders of the registration numbers of medical devices in Vietnam? - image from internet
Pursuant to Article 66 of the Decree 36/2016/ND-CP (amended by Clause 38.a Article 1 of the Decree 169/2018/ND-CP) stipulating responsibilities of the holders of the registration numbers of medical devices in Vietnam:
- Declare the applied standards or apply for registration of medical devices in accordance with this Decree;
- Establish and maintain a warranty center for medical devices or sign a contract with a warranty center;
- Prepare and retain documents for monitoring medical devices and trace origins of medical devices in accordance with this Decree, except for disposable medical devices defined by the product owners; inform Departments of Health and police authorities of any confusion or loss of medical devices containing narcotic substances and precursors or raw materials for production thereof.
- Provide adequate and accurate information about the product on the label and instructions manual of the medical devices in accordance with regulations of law on goods labels and provisions of this Decree;
- Issue prompt, adequate and accurate warnings about risks to users’ health and the environment; instructions for sellers and users on how to minimize the risks; provide information about requirements for transport, storage and use of the medical devices;
- Stop circulating and take corrective actions or recall defective medical devices in accordance with this Decree, and inform relevant parties. Destruction of defective medical devices shall comply with regulations of law on environmental protection, relevant laws; the destruction cost shall be paid by the registration number holder;
- Comply with regulations of law and inspection decisions issued by competent authorities;
- Pay compensation for damage caused by the defective medical devices as prescribed by law;
- Ensure that the following documents are effective during the effective period of the registration number:
+ The CFS (for imported medical devices);
+ The authorization letter in the case specified in Point a Clause 1 Article 21 of this Decree;
+ The certification of warranty qualification or documents proving 57]]]]]]]]]
- Ensure that the medical devices are only manufactured during the effective period of the certificate of conformity with quality control standards;
- Take responsibility for the legitimacy and accuracy of the documents posted while following the procedures specified in this Decree;
- Provide every health facility that buys the medical devices with 01 set of quality control documents specified in Clause 4 Article 30 of this Decree;
- Fulfill other obligations prescribed by law.
Above are responsibilities of the holders of the registration numbers of medical devices in Vietnam.
Best regards!
