Thông tư 14/2020/TT-BYT

CIRCULAR

MEDICAL DEVICE BIDDING AT PUBLIC HEALTH FACILITIES

Pursuant to the Law on Bidding No. 43/2013/QH13 dated November 26, 2013;

Pursuant to the Government’s Decree No. 63/2014/ND-CP dated June 26, 2014 elaborating regulations on contractor selection of the Law on Bidding;

Pursuant to the Government’s Decree No. 36/2016/ND-CP dated May 15, 2016 on medical device management, which is amended by the Government’s Decree No. 169/2018/ND-CP and Decree No. 03/2020/ND-CP;

Pursuant to the Government’s Decree No. 75/2017/ND-CP dated June 20, 2017 on functions, tasks, powers and organizational structure of the Ministry of Health;

At the request of Director of Medical Device and Work Department,

The Minister of Health promulgates a Circular on Medical device bidding at public health facilities,

Chapter I

GENERAL PROVISIONS

Article 1. Scope

This Circular provides for:

1. Classification of medical device contract packages.

2. Reporting medical device bidding.

3. Preparation of the bidding documents and request for proposals.

4. Planning selection of medical device contractor.

Article 2. Scope

1. This Circular applies to procurement of medical device of public health facilities that are funded by either:

a) State budget for frequent expenditures that are prescribed by the Law on State Budget and allocated by competent authorities within their annual budget (including additional funds in the year);

b) Non-business funding sources for execution of national target programs without establishment of investment projects;

c) Government-backed loans and other kinds of capital under management of the State;

d) Official development assistance (ODA) loans and grants intended for coverage of frequent expenditures; donations and aids from foreign non-governmental organizations, individuals and organizations that belong or does not belong to state budget (unless otherwise prescribed by the international treaty on ODA or concessional loan to which the Socialist Republic of Vietnam is a signatory);

dd) Revenues from fees and charges that can be used in accordance with regulations of law on fees and charges;

e) Revenue from non-business activities, funds for development of non-business activities, commendation funds, benefit funds and other lawful funds of public service providers;

g) Health insurance funds;

h) Other lawful sources of income (if any).

2. This Circular does not apply to procurement of medical devices commissioned or assigned by the State under the Government’s Decree No. 32/2019/ND-CP dated April 10, 2019 on assignment, commissioning or bidding for supply of public services and products covered by state budget for frequent expenditures.

3. Private health facilities that provide medical services covered by health insurance may apply regulations of this Circular to their procurement of medical devices.

Article 3. Application of bidding laws

The provision and publishing of bidding information, time limit and procedures for providing and publishing bidding information; contractor selection costs; retention of contractor selection documents; approving the contractor selection plan; bidding procedures; contractor selection methods and contracts shall comply with regulations of the Law on Bidding No. 43/2013/QH13, Decree No. 63/2014/ND-CP. Relevant bidding laws shall apply to other issues that are not regulated by this Circular.

Article 4. Classification of medical device contract packages

1. Classification

A medical device contract may contain one or several categories of medical devices, each of which may be classified as follows:

a) Group 1: medical devices that are both:

- Granted the Certificate of Free Sale (CFS) by at least 02 countries specified in Appendix I hereof ((hereinafter referred to as “reference countries); and

- Made in a reference country or Vietnam.

b) Group 2: medical devices that are both:

- Granted the CFS by at least 02 reference countries;

- Are not made in any reference country or Vietnam.

c) Group 3: medical devices that are both:

- Granted the CFS by at least 01 reference country;

- Made in a reference country or Vietnam.

d) Group 4: medical devices that are both:

- Granted the CFS by at least 01 reference country;

- Are not made in any reference country or Vietnam.

dd) Group 5: medical devices that are both:

- Granted a marketing authorization number granted in Vietnam (including those granted marketing authorization);

- Made in Vietnam.

e) Group 6: medical devices other than those specified in Points a, b, c, d and dd of this Clause.

2. The country of origin of a medical device is determined according to:

a) The import license;

b) The marketing authorization number (including the marketing authorization certificate); or

c) The CFS and ISO 13485 certification.

3. A bidder may apply for one or several Groups whose criteria are fully satisfied by their products, provided the bids are consistent among all Groups (classification does not apply to medical devices that are systems of multiple medical devices). To be specific:

a) A bidder whose products satisfy the criteria of Group 1 may apply to Groups 1, 2, 3, 4, 5, 6;

b) A bidder whose products satisfy the criteria of Group 2 may apply for Groups 2, 3, 4, 5, 6;

c) A bidder whose products satisfy the criteria of Group 3 may apply for Groups 3, 4, 5, 6;

d) A bidder whose products satisfy the criteria of Group 4 may apply for Groups 4, 5, 6;

dd) A bidder whose products satisfy the criteria of Group 5 may apply for Groups 5, 6;

e) A bidder whose products do not satisfy any of the criteria of Group 1, 2, 3, 4 and 5 may only apply for Group 6.

Article 5. Reporting medical device bidding

1. Within 20 days after the contractor selection result is approved, the head of the health facility shall submit a report according Appendix II hereof (for specialized devices) or Appendix III hereof (for other medical devices) to the authority that has the power to approve the contractor selection plan  and the Ministry of Health (Finance and Planning Department).

2. Within 10 working days from the receipt of the contractor selection result report, the receiving authority shall decide whether to approve the contractor selection plan and the Ministry of Health (Finance and Planning Department) shall publish it on its website.

3. In case the bidder commits violations during the bidding process, the health facility shall inform a competent authority. The result shall be reported to the Ministry of Health (Finance and Planning Department) within 05 working days from the day on which it is available according to Appendix V hereof, which will be the basis for health facilities to evaluate and select contractors in the future.

Chapter II

CONTRACTOR SELECTION PLAN

Article 6. Preparation of the plan for selection of medical device contractor

In addition to regulations of the Law on Bidding No. 43/2013/QH13, Decree No. 63/2014/ND-CP and relevant guiding documents, the following regulations shall be complied with during preparation of the contractor selection plan:

1. The contractor selection plan is prepared annually or whenever it is necessary on the following grounds:

a) For procurement of specialized medical devices: The procurement budget shall depend on allocated funds and approved quantities of specialized medical devices according to Circular No. 08/2019/TT-BYT;

b) For procurement of other medical devices: The procurement budget shall depend the funding sources and actual procurement and use of medical devices of the previous year and estimated demand for the medical devices in the planning year.

2. The name of the contract package shall reflect its nature, content and scope; be suitable for the project or procurement budget. In case a contract package consists of separate parts, the contractor selection plan must specify the basic content of each part.

Article 7. Preparation of the bidding documents and request for proposals

In addition to regulations of the Law on Bidding No. 43/2013/QH13, Decree No. 63/2014/ND-CP and relevant guiding documents, the following regulations shall be complied with during preparation of the bidding documents or request for proposals:

Classify medical devices in accordance with Article 4 of this Circular. Medical devices of the same category can be put into one or several groups according to their necessity, uses and values.

2.  Technical requirements of each device shall be established according to its necessity and uses. Technical requirements of specialized medical devices specified in Circular No. 08/2019/TT-BYT shall be established in accordance with Appendix IV hereof.

3. Bidders shall be requested to provide the number of the certificate of submission of the declaration of eligibility for trading medical devices, market authorization or import license of the proposed devices in accordance with Decree No. 36/2016/ND-CP, which is amended by Decree No. 169/2018/ND-CP and Decree No. 03/2020/ND-CP.

4. Specify the responsibilities of the contractor for transfer, installation and training to ensure effectiveness, quality and safety of patients and users.

5. Do not require or suggest bidders to offer import products if domestically manufactured or assembled products are qualified in terms of quality, quantity and prices; comply with incentive requirements (criteria, incentive calculation and supporting documents) of bidding laws.

6. Demand that the medical devices are provided by one of the following organizations and individuals:

a) Holders of marketing authorization number of the medical devices;

b) Authorized holders of marketing authorization number of the medical devices;

c) Organizations and individuals authorized by the organizations and individuals mentioned in Point b of this Clause;

d) Organizations and individuals authorized by the owner of the medical devices;

dd) Organizations and individuals authorized by the organizations and individuals mentioned in Point d of this Clause;

e) Organizations and individuals authorized by the organizations and individuals mentioned in Point dd of this Clause;

g) The holder of the license to import medical devices;

h) Organizations and individuals authorized by the organizations and individuals mentioned in Point g of this Clause;

Authorization shall comply with civil laws.

Article 8. Contract value

1. The contract value shall be estimated according to the total investment or cost estimate of the project, and is inclusive of all costs, cost contingency, fees, charges and taxes.

2. In case a contract is divided into multiple parts, each of them shall have a list of products, their qualities, units, unit prices and value of that part as prescribed in Clause 1 of this Article.

3. When estimating the contract value, the health facility shall examine the successful bids within the last 12 months on the website of the authority that has the power to approve the contractor selection plan and the Ministry of Health. To be specific:

a) The reserve price of a device must not exceed the successful bid of the same device or the announced successful bid. Otherwise, explanation shall be provided;

b) In case a successful bid is not available, the contract value shall be estimated according to the documents prescribed in the Law on Bidding No. 43/2013/QH13, Decree No. 63/2014/ND-CP and instructional documents on contract valuation and market price of the device at the time when the contractor selection plan is prepared.

Article 9. Application for approval for the contractor selection plan

In addition to regulations of the Law on Bidding No. 43/2013/QH13, Decree No. 63/2014/ND-CP and relevant guiding documents, an application for approval for the contractor selection plan shall include at least the following documents:

1. The written request for approval for the contractor selection plan.

2. Relevant documents and legal documents.

3. Brief report on execution of the preceding year’s contractor selection plan and use of medical devices (if any) and brief description of the contractor selection that needs approval.

4. The documents that are the basis for preparation of the contractor selection plan prescribed in Clause 1 Article 6 of this Circular.

5. The minutes of the meeting of the science council of the health facility expressing consensus on the plan, necessity, devices, quantity, technical requirements and cost estimate. The meeting must be attended by representatives of relevant departments/wards and the unit that will use the medical devices.

6. The documents that are the basis for estimating the contract value prescribed in Article 8 of this Circular.

Chapter III

IMPLEMENTATION CLAUSES

Article 10. Effect

This Circular comes into force on September 01, 2020.

Article 11. Transition clauses

1. The contractor selection plans that are approved before the effective date of this Circular may be carried on as approved and the results shall be reported in accordance with Article 5 of this Circular.

2. The contractor selection plans that submitted for approval before the effective date of this Circular and have not been approved shall continue to be appraised and will be approved if they are conformable with regulations of this Circular. The results shall be reported in accordance with Article 5 of this Circular.

Article 12. Organization of implementation

Heads of health facilities shall:

1. Request the supply department to determine the demand, prepare a list of needed devices, their costs, specifications, functions, standards, technological generation, safety, training, necessary infrastructure for installation and effective use of these devices.

2. Make decision and plan the use of medical devices on the basis of annual procurement limits, the demand for medical devices of various departments/wards/units, opinions and proposals of the supply department, and opinion of the science council.

Difficulties that arise during the implementation of this Circular should be reported to the Ministry of Health for consideration./.