Circular 14/2020/TT-BYT medical equipment bidding at public health establishments

CIRCULAR

Providing for medical equipment bidding at public health establishments

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

Pursuant to the Government’s Decree No. 63/2014/ND-CP dated June 26, 2014, detailing a number of articles of the Bidding Law regarding contractor selection;

Pursuant to the Government’s Decree No. 36/2016/ND-CP dated May 15, 2016, on medical equipment management, which is amended and supplemented by the Government’s Decree No. 169/2018/ND-CP dated December 31, 2018 and Decree No. 03/2020/ND-CP dated January 1, 2020;

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

At the proposal of the Director of the Department of Medical Equipment and Works,

The Minister of Health promulgates the Circular providing for medical equipment bidding at public health establishments.

Chapter I

GENERAL PROVISIONS

Article 1. Scope of regulation

This Circular provides for a number of contents regarding:

1. Classification and bidding into groups of medical equipment bidding packages.

2. Report on the implementation of medical equipment bidding.

3. Preparation of bidding dossiers and dossiers of requirements.

4. Plan for selection of contractors for procurement of medical equipment.

Article 2. Scope of regulation

1. This Circular applies to the procurement of medical equipment of public health establishments that are funded by the following sources:

a) State budget for current expenditure in accordance with the Law on State Budget allocated by competent agencies in annual budget expenditure estimates of agencies or units (including additional funding sources in the year);

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

c) Credit capital guaranteed by the State and other capital managed by the State;

d) Official development assistance (ODA): loans and non-refundable aids balanced in current expenditures of the state budget; donations and aids from foreign non-governmental organizations, domestic and foreign individuals and organizations that belong to the state budget (unless otherwise prescribed by the 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 law provisions on fees and charges;

e) Revenues from non-business activities, funds for development of non-business activities, commendation funds, welfare funds and other lawful funds as prescribed by law provisions at public non-business units;

g) Health insurance funds;

h) Other lawful revenue sources as prescribed by law provisions (if any).

2. This Circular does not apply to cases of procurement of medical equipment ordered or assigned by the State in accordance with the Government’s Decree No. 32/2019/ND-CP dated April 10, 2019, prescribing the assignment of tasks, placement of orders, or bidding for provision of public products and services covered by state budget funds for current expenditures.

3. Private health examination and treatment establishments that provide health examination and treatment services covered by health insurance may apply regulations of this Circular in medical equipment bidding.

Article 3. Application of bidding laws

The provision and posting of bidding information; time limit and procedures for providing and posting bidding information; contractor selection costs; retention of dossiers  during the contractor selection process; approval of contractor selection plans; bidding procedures; contractor selection forms; contractor selection methods and contracts shall comply with regulations of the Bidding Law No. 43/2013/QH13, the Government’s Decree No. 63/2014/ND-CP dated June 26, 2014, detailing a number of articles of the Bidding Law regarding contractor selection (hereinafter referred to as the Decree No. 63/2014/ND-CP). Relevant bidding laws shall apply to other issues that are not regulated by this Circular.

Article 4. Classification and bidding into groups of medical equipment bidding packages

1. Classification

A medical equipment bidding package may contain one or several categories of medical equipment, each of which may be classified as follows:

a) Group 1: medical equipment that simultaneously meets the following criteria:

- Bring granted the Certificate of Free Sale by at least 02 SCI countries as specified in Appendix I issued together with this Circular (hereinafter referred to as “reference countries”);

- Being made in a reference country or Vietnam.

b) Group 2: medical equipment that simultaneously meets the following criteria:

- Being granted the Certificate of Free Sale by at least 02 reference countries;

- Not being made in any reference country or Vietnam.

c) Group 3: medical equipment that simultaneously meets the following criteria:

- Being granted the Certificate of Free Sale by at least 01 reference country;

- Being made in a reference country or Vietnam.

d) Group 4: medical equipment that simultaneously meets the following criteria:

- Granted the Certificate of Free Sale by at least 01 reference country;

- Not made in any reference country or Vietnam.

dd) Group 5: medical equipment that simultaneously meets the following criteria:

- Being granted a circulation number in Vietnam (including those that are granted a certificate of circulation registration);

- Being made in Vietnam.

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

2. The determination of the manufacturing country of medical equipment shall be based on information recorded on any of the following papers:

a) The import license;

b) The circulation number (including the circulation registration certificate);

c) The certificate of free sale and ISO 13485 certification.

3. Bidding into groups of medical equipment bidding packages

A bidder whose medical equipment satisfies the criteria of any group may apply for that group; in cases where their medical equipment satisfies the criteria of multiple groups, the bidder may apply for one or several groups, but the bids must be consistent among all groups (the criteria for classification does not apply to medical equipment that are systems of multiple medical equipment), specifically as follows:

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

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

c) A bidder whose medical equipment satisfies the criteria of Group 3 may apply for Groups 3, 4, 5, 6;

d) A bidder whose medical equipment satisfies the criteria of Group 4 may apply for Groups 4, 5, 6;

dd) A bidder whose medical equipment satisfies the criteria of Group 5 may apply for Groups 5, 6;

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

Article 5. Report on the implementation of medical equipment bidding

1. Within 20 days after the contractor selection result is approved, the head of health establishment shall submit a report according to the form specified in Appendix II (for specialized medical equipment) or Appendix III issued together with this Circular (for other medical equipment) to agencies competent to approve the contractor selection plan and the Ministry of Health (the Finance and Planning Department).

2. Within 10 working days from the receipt of the contractor selection result report, the agencies competent to approve the contractor selection plan and the Ministry of Health (the Finance and Planning Department) shall publish it on their website.

3. In cases where the bidder commits violations during the bidding process for medical equipment supply, the health establishment shall be responsible for reporting it to competent agencies for handling in accordance with the law on bidding and other relevant laws. The handling result shall be reported to the Ministry of Health (the Finance and Planning Department) within 05 working days from the day on which it is available according to the form specified in Appendix V issued together with this Circular, which will be the basis for health establishments to evaluate and select contractors in the next times.

Chapter II

CONTRACTOR SELECTION PLAN

Article 6. Preparation of plan for selection of medical equipment contractor

In addition to regulations of the Bidding Law No. 43/2013/QH13, Decree No. 63/2014/ND-CP and relevant guiding documents, the preparation of plan for selection of medical equipment contractor must comply with the following provisions:

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

a) With regard to bidding packages for procurement of specialized medical equipment: The preparation of procurement estimate shall depend on allocated funding sources and approved norms of specialized medical equipment in accordance with the Minister of Health’s Circular No. 08/2019/TT-BYT dated May 31, 2019, guiding the standards and norms for using specialized machinery and equipment in the medical field (hereinafter referred to as the Circular No. 08/019/TT-BYT);

b) With regard to bidding packages for procurement of other medical equipment: The preparation of procurement estimate shall depend on the funding sources and actual procurement and use of medical equipment of the previous year and estimated demand for the medical equipment in the planning year.

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

Article 7. Preparation of bidding dossiers and dossiers of requirements

In addition to regulations of the Bidding Law No. 43/2013/QH13, Decree No. 63/2014/ND-CP and relevant guiding documents, the preparation of bidding dossiers and dossiers of requirements must comply with the following regulations:

1. Classifying medical equipment in accordance with Article 4 of this Circular, in which each type of medical equipment can be classified into one or multiple groups according to their necessity, uses and values.

2.  Technical requirements of medical equipment shall be established according to its necessity and uses. Technical requirements of specialized medical equipment specified in the Circular No. 08/2019/TT-BYT shall be established in accordance with Appendix IV issued together with this Circular.

3. Contractors shall be requested to provide the number of receipts for declaration of eligibility for trading medical equipment, circulation number or import license number of proposed medical equipment in accordance with the Government’s Decree No. 36/2016/ND-CP dated May 15, 2016, on medical equipment management, which is amended and supplemented by the Government’s Decree No. 169/2018/ND-CP dated December 31, 2018, and Decree No. 03/2020/ND-CP dated January 1, 2020;

4. The responsibilities of contractors shall be specified regarding the transfer, installation, training and instruction to ensure effectiveness, quality and safety of patients and users.

5. Not making requirements or orientations for contractors participating in bidding to offer import products if domestically manufactured or assembled products are qualified in terms of quality, quantity and prices; complying with incentive requirements (criteria, incentive value calculation and supporting documents) in accordance with law provisions on bidding.

6. Regulating that the medical equipment is provided by one of the following organizations and individuals:

a) Organizations and individuals being the holders of circulation number of medical equipment;

b) Organizations and individuals authorized by the holders of circulation number of medical equipment;

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

d) Organizations and individuals authorized by the owners of medical equipment;

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

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

g) Holder of licenses to import medical equipment;

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

The authorization shall comply with civil laws.

Article 8. Bidding package price

1. The bidding package price shall be estimated according to the total investment or cost estimate of the project. The bidding package price is the total value of all costs for implementing the bidding package, including cost contingencies, fees, charges and taxes.

2. In cases where a bidding package is divided into multiple parts, in addition to stating the total value of the bidding package, each part shall clearly state the list, quantity, unit, unit price and total value of that part as prescribed in Clause 1 of this Article.

3. When making a bid package price estimate, the health establishment shall examine the successful bids within the last 12 months on the website of agencies competent to approve the plan and the Ministry of Health as the basis for formulating the unit price of medical equipment, specifically as follows:

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

b) In cases where a successful bid is not available, the bid package price shall be formulated and determined according to the documents prescribed in the Bidding Law No. 43/2013/QH13, Decree No. 63/2014/ND-CP and relevant bidding documents on formulating bidding package prices to ensure compatibility with the market price of such medical equipment at the time when the contractor selection plan is prepared.

Article 9. Dossiers of approval for contractor selection plan

In addition to regulations of the Bidding Law No. 43/2013/QH13, Decree No. 63/2014/ND-CP and relevant guiding documents, a dossier of approval for a 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 dossiers.

3. Brief report on the execution of the preceding year’s contractor selection plan and use of medical equipment (if any) and brief description of the contractor selection being submitted for approval.

4. Documents used as a basis for preparation of the contractor selection plan as prescribed in Clause 1, Article 6 of this Circular.

5. Minutes of the meeting of the science council of the health establishment expressing consensus on the plan, necessity, list, quantity, technical requirements and cost estimate. The meeting must be attended by representatives of relevant functional faculties/departments and the unit that will use such medical equipment.

6. Documents used as a basis for estimating the bid package price as prescribed in Article 8 of this Circular.

Chapter III

IMPLEMENTATION PROVISIONS

Article 10. Effect

This Circular takes effect from September 1, 2020.

Article 11. Transitional provisions

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

2. The contractor selection plans that have been submitted for approval before the effective date of this Circular but have not been approved shall continue to be appraised and shall 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 establishments shall:

1. Direct the department of medical equipment and supplies or the medical equipment management department at health establishments to determine the demand, prepare a list of needed medical equipment, make the plan and estimate for medical equipment procurement, and advise heads of health establishments on specifications, functions, standards, technological generation, safety, training, necessary infrastructure for installation, aiming at meeting professional requirements and promoting investment efficiency.

2. Make decision and plan on the use of medical equipment at health establishments on the basis of the annual procurement limits, the demand for medical equipment of multiple faculties/departments as well as specialized units, opinions and proposals of the department of medical equipment and supplies or the medical equipment management department at health establishments, and opinions of the science council.

Any problems arise in the course of implementation shall be timely reported to the Ministry of Health for consideration and settlement./.

For the Minister

The Deputy Minister

TRUONG QUOC CUONG

* All Appendices are not translated herein.