Chương VI Nghị định 98/2021/NĐ-CP: Quản lý mua bán trang thiết bị y tế

Chapter VI

MANAGEMENT OF TRADING OF MEDICAL DEVICES

Section 1. ELIGIBILITY REQUIREMENTS TO BE SATISFIED BY TRADING ESTABLISHMENTS

Article 40. Requirements for trading in Class-B, C, D medical devices

To be permitted to trade in Class-B, C, D medical devices, an establishment must:

1. Have at least 01 employee who has an associate degree, or higher, in technology, medicine, pharmacy, chemistry, biology or medical devices, or an associate degree, or higher, suitable for the medical devices sold by the establishment.

2. Have warehouse and vehicles that satisfy the following requirements:

a) The warehouse must:

- have an area suitable for the categories and quantities of medical devices stored therein;

- be well ventilated, dry and clean, and separated from sources of pollution;

- satisfy storage requirements for the medical devices laid down in their user manuals.

b) The vehicle used for transporting medical devices to buyers must be suitable for categories of such medical devices;

A trading establishment that does not have a warehouse or vehicle may sign a contract with a qualified storage or transport service provider.

3. Requirements for trading in medical devices that contain narcotic substances or precursors:

a) The chief technician has a bachelor’s degree in medical devices, medicine, pharmacy, pharmaceutical chemistry or biology.

b) The trading establishment must have a warehouse that satisfies the requirements laid down in Article 7 of the Government’s Decree No. 80/2001/ND-CP dated November 05, 2001.

c) There is an inventory monitoring system for medical devices containing narcotic substances and precursors.

Article 41. Application and procedures for declaration of eligibility for medical device trading

1. An application for declaration of eligibility for medical device trading consists of:

a) The declaration of eligibility for medical device trading;

b) A personnel list;

c) Documents proving that the warehouse and vehicle satisfy the requirements specified in Clause 2 Article 40 of this Decree. These documents must be certified by the applicant;

d) Documents proving that the warehouse and inventory monitoring system for medical devices containing narcotic substances and precursors comply with the requirements laid down in Clause 3 Article 40 of this Decree. Such documents shall be certified by the establishment making declaration of eligibility for trading in medical devices that contain narcotic substances and precursors.

2. Procedures for declaration of eligibility for medical device trading:

a) Before trading medical devices, the trading establishment shall submit an application for declaration of eligibility for medical device trading to the Department of Health of province where the trading establishment is located.

b) After receiving the application (including the application fee payment as prescribed by the Ministry of Finance), the Department of Health of province where the trading establishment is headquartered shall publish on the Portal on management of medical devices all information about and application for declaration of eligibility for medical device trading.

c) During its operation, the trading establishment shall prepare a notice of changes which is accompanied by supporting documents for such changes, and update such documents to its application for declaration of eligibility for medical device trading published on the Portal on management of medical devices within 03 working days from the occurrence of such changes.

Article 42. Trading in medical devices without satisfying eligibility requirements and following procedures for declaration of eligibility for medical device trading

1. Class-B, C, D medical devices included in the list of medical devices promulgated by the Minister of Health shall be traded as normal goods.

2. Establishments trading in the medical devices prescribed in Clause 1 of this Article shall not be required to satisfy eligibility requirements laid down in Article 40 of this Decree and follow procedures for declaration of eligibility for medical device trading as prescribed in Article 41 of this Article but must still meet the storage and transport requirements as prescribed by product owners.

Section 2. MANAGEMENT OF PRICES OF MEDICAL DEVICES

Article 43. Rules for state management of medical device prices

1. Manage prices of medical devices according to the market mechanism; respect the right to pricing and price competition of entities trading in medical devices in accordance with regulations of law.

2. Ensure transparency of prices of medical devices placed on the market.

3. Protect lawful rights and interests of medical device traders and users, and of the State.

4. Take measures for ensuring management of medical device prices appropriate for socio-economic development in each period.

Article 44. Measures for management of medical device prices

1. Prices of medical devices must be declared in accordance with regulations of this Decree before they are placed on the market in Vietnam, and declared again whenever they are changed.

2. Wholesale and retail prices in VND of medical devices shall be posted at transaction or selling locations of medical device trading establishments; such prices shall be publicly posted on a board, paper or otherwise posted.

3. Successful bids for medical devices of public health facilities must be made publicly available.

4. Trading establishments shall not be allowed to trade medical devices before their prices are declared or at prices higher than those available on the Ministry of Health’s Portal on management of medical devices at the time of trading.

Article 45. Contents and responsibility for declaration of medical device prices

1. Contents of declaration of medical device prices:

a) Name and category of the medical device;

b) Manufacturing country;

c) Unit;

d) Import cost price of the imported medical device or manufacturing cost of the domestically manufactured medical device;

dd) Expected profits;

e) The highest price of the medical device determined according to its design configurations, technical functions and unit;

g) Prices of accessories and parts (if any);

h) Warranty or maintenance costs (if any);

i) Training costs (if any);

k) Other costs (if any);

2. Contents about medical device prices to be publicly posted:

a) Name and category of the medical device;

b) Manufacturer and manufacturing country; product owner and country of product owner;

c) Unit;

d) The highest price of the medical device determined according to its design configurations, technical functions and unit;

dd) Prices of accessories and parts (if any);

e) Warranty or maintenance costs (if any);

g) Training costs (if any);

h) Other costs (if any);

3. Prices of medical devices shall be expressed in VND.

4. Registration number holders shall:

a) Make declaration of prices of their medical devices according to the declaration contents specified in Clause 1 of this Article and publish information on the Ministry of Health’s portal before such medical devices are placed on the market of Vietnam;

b) Update prices of medical devices whenever they are changed;

c) Request distributors to comply with the provisions of Points a and b of this Article in the case prescribed in Point c Clause 1 Article 25 of this Decree. In case of multiple distributors of the same medical device, one distributor shall be appointed to declare the medical device price. Other distributors shall not be required to make price declaration but shall not sell the medical device at a price higher than that declared by the appointed distributor;

d) Make declaration and explain elements constituting the medical device price to tax authorities or at the request of regulatory authorities.

5. A price posted on the Ministry of Health’s portal must include adequate information prescribed in Clause 2 of this Article.

Section 3. EXPORT AND IMPORT OF MEDICAL DEVICES

Article 46. Rules for management of import and export of medical devices

1. Importers and exporters of medical devices must satisfy eligibility requirements laid down in the law on import and export and assume responsibility to ensure quality, quantities, categories and intended purposes of their imported/exported medical devices.

2. Medical devices that have been granted registration numbers in Vietnam may be exported and imported without limits on quantities and are exempt from the Ministry of Health’s approval.

3. Issuance of CFS for medical devices shall comply with regulations of the law on foreign trade management.

4. Temporary import for re-export, temporary export for re-import, or transit of medical devices shall comply with regulations of law.

5. Import of used medical devices shall comply with regulations of the law on foreign trade management.

Article 47. Export and import of medical devices

1. Domestic enterprises are encouraged to manufacture medical devices for export.

2. An organization or individual that wishes to import the medical device that has been granted registration number shall:

a) be the registration number holder or be authorized in writing by the registration number holder. When authorizing import of medical devices, the registration number holder shall send a copy of the authorization letter to the registration number issuer and the customs authority;

b) have a warehouse and vehicles satisfying the requirements laid down in Clause 2 Article 40 of this Decree or have entered into a contract with a qualified storage and transport service provider;

c) have a warehouse and an inventory monitoring system for medical devices containing narcotic substances and precursors that meet the requirements laid down in Clause 3 Article 40 of this Decree.

3. Procedures for import and export of medical devices shall comply with regulations of the law on customs. Importers of medical devices shall not be required to prove their satisfaction of the requirements laid down in Clause 2 of this Article when following customs procedures.

Article 48. Import license

1. An import license is required in the following cases:

a) Unregistered medical devices are imported to serve scientific research, testing, inspection, experiment, performance evaluation, or instruction for use or device modification only;

b) Unregistered medical devices are imported to serve epidemic prevention and control, or disaster recovery;

c) Unregistered medical devices are imported as assistance or humanitarian aid; gifts or presents given to health facilities; or to serve display at trade fair, exhibition or product launch event;

d) Unregistered medical devices are imported to serve charitable medical examination and treatment;

dd) Unregistered medical devices are imported for personal treatment of illness, including personalized medical devices, or to serve a health facility’s special diagnosis demand;

e) Used medical devices:

- are imported to serve research or training (no use on humans and for diagnostic and treatment purposes); or

- are temporarily imported for re-export to serve display, product launch event, trade fair or exhibition.

Procedures for import, temporary import for re-export of medical devices shall comply with regulations of the law on foreign trade management.

2. An application for the import license consists of:

a) The application form for import license;

b) A synopsis of the technical description of the medical device in Vietnamese;

c) Certificate of conformity with quality control standards of the manufacturer bearing the applicant’s certification;

d) If the medical device is imported to serve research: a certified true copy of the decision to approve the research and documents bearing the applicant’s certification proving that the device has been granted marketing authorization by a competent authority;

dd) If the medical device is imported to serve training purposes: the original copy of the training program and documents bearing the applicant’s certification proving that the device has been granted marketing authorization by a competent authority;

e) If the medical device is imported to serve testing, inspection, experiment, or performance evaluation: the certification indicating the quantity of the imported device given by the agency competent to carry out such testing, inspection, experiment, or performance evaluation;

g) If the medical device is imported as aid: a copy of the decision to approve the aid and documents bearing the applicant’s certification proving that the device has been granted marketing authorization by a competent authority;

h) If the medical device is imported as gift or present given to a health facility: the original copy of the training program and documents bearing the applicant’s certification proving that the device has been granted marketing authorization by a competent authority;

i) If the medical device is imported to serve charitable medical examination and treatment: documents bearing the applicant’s certification proving that the device has been granted marketing authorization by a competent authority;

k) If the medical device is imported to serve a health facility’s special diagnosis demand: documents bearing the applicant’s certification proving that the device has been granted marketing authorization by a competent authority;

l) If the medical device is imported to serve personal treatment of illness, including personalized medical devices: a copy of the physician’s prescription which is consistent with the applicant’s illness;

m) If the medical device is imported to serve a trade fair, exhibition, display or product launch event: copies of documents on the program, invitation letter and service contract;

n) If the medical device is imported to serve the purposes of epidemic prevention and control or disaster recovery, the following documents are required:

- A competent authority’s approval for import of the medical device to serve epidemic prevention and control or disaster recovery;

- Documents bearing the applicant’s certification proving that the device has been granted marketing authorization or license for emergency use by a competent authority.

3. Procedures for processing an application for license to import medical devices:

a) If the application is satisfactory, the Ministry of Health shall process it within 15 working days, or 02 working days with respect to an unregistered medical device that is imported to serve epidemic prevention and control or disaster recovery, from the receipt of the adequate and valid application (including the application fee receipt as prescribed by the Ministry of Finance). If an application is refused, a written response indicating reasons for such refusal shall be provided.

The import license shall be sent to the applicant and customs authorities.

b) If the application is not satisfactory, the Ministry of Health shall send a request for modification, in which such documents and contents requiring modification must be specified, to the applicant within 10 days, or 02 working days with respect to an unregistered medical device that is imported to serve epidemic prevention and control or disaster recovery, from the receipt of the application.

c) The applicant shall comply with the request for modification and send modified documents to the Ministry of Health as requested.

If the modified application is still unsatisfactory, the Ministry of Health shall continue sending another request for modification of the application to the applicant.

d) If the applicant fails to provide the modified application within 30 days from the receipt of the Ministry of Health’s request for modification, the application shall be rejected.

dd) If the modified application is satisfactory, the Ministry of Health shall issue an import license in accordance with Point a of this Clause. The import license shall be sent to the applicant and customs authorities.

Article 49. Application for Certificate of Free Sale (CFS) for medical devices

1. An application for CFS for a medical device consists of:

a) The application form for CFS.

b) A certified true copy of the unexpired certificate of conformity with quality control standards issued by a conformity assessment body as prescribed by law.

2. Procedures for the CFS shall comply with the Government’s Decree No. 69/2018/ND-CP dated May 15, 2018.

Article 50. Authority and procedures for issuance, re-issuance and revocation of CFS

1. The Minister of Health shall consider issuing, re-issuing and revoking CFS for medical devices.

2. Procedures for issuance, re-issuance and revocation of CFS shall comply with the Prime Minister’s regulations on issuance of CFS.

Section 4. RIGHTS AND OBLIGATIONS OF ORGANIZATIONS AND INDIVIDUALS ENGAGED IN TRADING OF MEDICAL DEVICES

Article 51. Rights of medical device trading establishments

1. Request the medical device seller to provide adequate information and documents serving the tracing of origin and warranty on the medical device.

2. Request importers, distributors and users to cooperate in recalling and handling defective medical devices.

3. Request the registration number holder or warranty center that is recognized by the product owner to provide warranty on the medical device.

4. Receive notice of defective medical device from the registration number holder.

5. Exercise other rights as prescribed by laws.

Article 52. Obligations of medical device trading establishments

1. Implement internal control measures to maintain the quality of medical devices as prescribed by the registration number holder.

2. Provide users with adequate and timely information about:

a) Instructions for use of medical devices; conditions for ensuring safety, storage, calibration, inspection and maintenance of medical devices;

b) Notices of defective medical devices.

3. Declare and post medical device prices in accordance with regulations of law. Do not trade medical devices before their prices are declared or at prices higher than those available on the Ministry of Health’s Portal on management of medical devices at the time of trading.

4. Keep documents on management of medical devices and carry out tracing of origin and recall of medical devices in accordance with regulations of this Decree.

5. Promptly notify registration number holders and state regulatory authorities of defective medical devices.

6. Comply with regulations of law and inspection decisions issued by competent authorities.

7. Perform other obligations as prescribed by law.