What are responsibilities of registration number holders in medical device management in Vietnam?

What are responsibilities of registration number holders in medical device management in Vietnam?

According to Clause 3, Article 74 of Decree No. 98/2021/ND-CP, stipulating responsibilities of medical device traders, in which:

3. Registration number holders shall:

a) Carry out classification of medical devices, publish on the Ministry of Health’s Portal and assume legal responsibility for their classification results;

Take correction measures for incorrect classification results that reduce the level of risks of classified medical devices or in term of authority specified in this Decree.

b) Follow procedures for declaration of applied standards or application for registration of medical devices in accordance with this Decree. Assume legal responsibility for the accuracy and truthfulness of their applications for registration number;

c) Establish and maintain operation of warranty centers for medical devices or enter in service contracts with qualified warranty service providers, except disposable medical devices as defined by product owners or cases where there are documents proving that the medical device is not under warranty;

d) Prepare and keep documents on management of medical devices and carry out tracing of origin of medical devices as prescribed in this Decree, except disposable medical devices as defined by product owners; submit reports to police authorities on loss of medical devices or raw materials for manufacture of medical devices that contain narcotic substances and precursors;

dd) Provide adequate and accurate information about the product on the label and user manual of the medical devices in accordance with regulations of law on goods labels and provisions of this Decree;

e) 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 medical devices;

g) Promptly stop placement on the market, take corrective actions against or recall defective medical devices in accordance with this Decree, and notify relevant parties. Destruction of defective medical devices shall comply with regulations of law on environmental protection and relevant laws; the destruction costs shall be paid by the registration number holder;

h) Comply with regulations of law and inspection decisions issued by competent authorities;

i) Pay compensation for damage caused by defective medical devices as prescribed by law;

k) Ensure that the following documents are effective during the effective period of the registration number:

- The CFS (for imported medical devices);

- The authorization letter, except the case specified in Point a Clause 1 Article 25 of this Decree;

- Certificate of eligibility to provide warranty services, except disposable medical devices defined by product owners or cases where there are documents proving that the medical device is not under warranty.

l) Ensure that the medical devices are only manufactured during the effective period of the certificate of conformity with quality control standards;

m) Take legal responsibility for the legitimacy and accuracy of the documents posted while following the procedures specified in this Decree;

n) Provide every health facility that buys the medical devices with 01 set of quality control documents specified in Clause 4 Article 33 of this Decree;

o) Directly or designate an organization to declare and update selling prices of medical devices;

p) Perform other obligations as prescribed by law.

Best Regards!