Chương XII : Tổ chức thực hiện

Chapter XII

ORGANIZATION OF IMPLEMENTATION

Article 70. Responsibilities of Ministry of Health

The Ministry of Health shall assume responsibility before the Government for state management of medical devices and have the following tasks and powers:

1. Submit to the Government or Prime Minister to promulgate, or promulgate within their jurisdiction, legislative documents, national technical regulations, strategies, policies and plans on medical devices.

2. Direct and organize the implementation of legislative documents, national technical regulations, strategies, policies and plans on medical devices.

3. Organize information dissemination and communication on medical devices.

4. Provide training for human resources in the field of medical devices.

5. Publish the following information on the Ministry of Health’s Portal:

a) Prices of medical devices declared by enterprises;

b) Successful bids for medical devices of State-owned health facilities nationwide;

c) List of medical devices whose registration number has been revoked.

6. Decide whether or not to apply provisions of this Decree to products or goods are considered as medical devices in some countries but may not be considered as such in other countries.

7. Carry out inspection and settle complaints, denunciations and take actions against violations in the field of medical devices. During inspection of medical device prices, if any establishment is found to inadequately declare medical device prices, the competent authority affiliated to the Ministry of Health shall request the subject establishment to review their price information and provide explanations.

8. Update and publish the list of organizations specified in Point a Clause 2 Article 29 of this Decree.

9. Provide detailed regulations on classification of medical devices which must be conformable with ASEAN’s treaties on classification of medical devices to which Vietnam is a signatory; issue practical training programs in classification of medical devices.

10. Issue the list of medical devices subject to inspection and class-based inspection procedures for listed medical devices.

11. Provide guidelines for preparation of ASEAN Common Submission Dossier Template (CSDT).

12. Provide specific provisions on templates used during the implementation of this Decree.

Article 71. Responsibilities of Ministry of Science and Technology

1. Issue the list of medical devices which are measuring devices subject to sample approval, inspection and calibration after obtaining the consent from the Ministry of Health.

2. Play the leading role and cooperate with the Ministry of Health in formulating national standards for medical devices; quality inspection of medical devices that are measuring devices and radiation equipment.

Article 72. Responsibilities of Ministry of Finance

1. Provide guidelines for management of public assets that are medical devices by State-owned health facilities after obtaining opinions from the Ministry of Health.

2. Provide specific provisions on management and use of fees and charges in the field of medical devices in accordance with regulations of law on fees and charges.

3. Carry out inspection and take actions against violations in the field of medical devices.

Article 73. Responsibilities of provincial People's Committees

1. Bear responsibility to manage activities relating to trading and use of medical devices in the province.

2. Organize information dissemination and communication on medical devices in the province.

3. Provide training for human resources in the field of medical devices in the province.

4. Publish on the Portal of the provincial People's Committee and send to the Ministry of Health the following information:

a) Successful bids for medical devices of State-owned health facilities in the province.

b) List of medical devices whose registration number has been revoked in the province.

5. Carry out inspection and settle complaints, denunciations and take actions against violations in the field of medical devices in the province.

Article 74. Responsibilities of medical device traders

1. Medical device traders shall assume responsibility for safety and quality of their medical devices.

2. Domestic medical device manufacturers shall assume responsibility to manage quality of medical devices during manufacture, transport and storage of medical devices according to their applications for registration number.

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.

4. Traders, exporters, importers and transferors of medical devices, raw materials, or substances for external quality assessment that contain narcotic substances and precursors shall submit annual reports to the Ministry of Health and Ministry of Public Security by January 15 of the following year.