CIRCULAR

REGULATIONS ON CERTAIN CONTENTS IN PROCUREMENT OF MEDICAL EQUIPMENT AT PUBLIC HEALTH CARE FACILITIES

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

Pursuant to Decree No. 63/2014/NĐ-CP dated June 26, 2014 of the Government detailing implementation of certain provisions of the Law on Bidding regarding selection of contractors;

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

Pursuant to the Government's Decree No. 75/2017/NĐ-CP dated June 20, 2017 stipulating 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 Health Facilities,

The Minister of Health issues this Circular prescribing certain contents in procurement of medical equipment at public health care facilities.

PART I

GENERAL PROVISIONS

Article 1. Scope of Regulation

This Circular prescribes certain contents regarding:

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

2. Reporting on the implementation of medical equipment procurement tenders.

3. Preparation of tender invitation documents and request for proposal documents.

4. Plan for selecting contractors for purchasing medical equipment.

Article 2. Scope of Application

Article 1. This Circular applies to the procurement of medical equipment at public health care facilities using one of the following sources of funds:

a) Recurrent budget expenditure according to the State Budget Law allocated by competent authorities in the annual state budget estimate of agencies and units (including supplementary funding during the year);

b) Capital for implementing national target programs in cases carried out under non-investment project forms;

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

d) Official Development Assistance (ODA) capital: Loans and non-reimbursable aid coordinated within recurrent state budget expenditure; assistance and donations from foreign non-governmental organizations, individuals, and organizations inside and outside Vietnam under state budget (except where international agreements on ODA and concessional loans to which the Socialist Republic of Vietnam is a member provide otherwise);

e) Revenue from fees and charges used in accordance with laws on fees and charges;

f) Operating revenue, development fund for operating activities, reward fund, welfare fund, and other lawful funds as prescribed by law at public service units;

g) Health Insurance Fund;

h) Other lawful revenues (if any) as prescribed.

Article 2. This Circular does not apply to cases of medical equipment procurement ordered or assigned plans to implement according to Decree No. 32/2019/NĐ-CP dated April 10, 2019 of the Government on assigning tasks, ordering or tendering for provision of products and services under the state budget from recurrent expenditure.

Private medical examination and treatment establishments participating in health insurance examination and treatment may refer to and apply the provisions of this Circular in medical equipment procurement tenders.

Article 3. Application of legal regulations on procurement

Provision and publication of tender information; deadlines, procedures for providing and publishing tender information; costs during the contractor selection process; archiving of documents during the contractor selection process; approval of the contractor selection plan; tender procedures; methods of selecting contractors; and performance contracts shall be implemented in accordance with the Procurement Law No. 43/2013/QH13, Decree No. 63/2014/NĐ-CP dated June 26, 2014 of the Government detailing implementation of certain provisions of the Procurement Law on contractor selection (hereinafter referred to as Decree No. 63/2014/NĐ-CP), and other relevant procurement laws not specified in this Circular.

Article 4. Provisions on classification and bidding for groups in medical equipment tender packages

1. Provisions on classification

A medical equipment tender package may include one or more types of medical equipment, and each type of medical equipment may be classified into groups as follows:

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

- Obtained free circulation certificates from at least two countries listed in Appendix I attached to this Circular (hereinafter referred to as reference countries);

- Produced in reference countries or produced in Vietnam.

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

- Obtained free circulation certificates from at least two reference countries;

- Not produced in reference countries or produced in Vietnam.

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

- Obtained a free circulation certificate from at least one reference country;

- Produced in reference countries or produced in Vietnam.

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

- Obtained a free circulation certificate from at least one reference country;

- Not produced in reference countries or produced in Vietnam.

đ) Group 5 includes medical equipment that simultaneously meet the following criteria:

- Registered with a circulation number in Vietnam (including cases where a registration certificate for free circulation has been issued);

- Produced in Vietnam.

e) Group 6 includes medical equipment that does not fall under the provisions of points a, b, c, d, and đ of this Clause.

2. Determination of the country of production of medical equipment shall be based on information recorded on one of the following documents:

a) Import permit;

b) Circulation number (including registration certificate for free circulation);

c) Free circulation certificate and certificate of compliance with ISO 13485 quality management standards.

3. Provisions on bidding for groups in medical equipment tender packages Bidders whose medical equipment meets the criteria of a group may bid for that group; if the medical equipment meets the criteria of multiple groups, the bidder may bid for one or more groups and must have a unified bid price across all groups in which the bidder bids (the group classification criteria do not apply to systems consisting of multiple individual medical devices), specifically as follows:

a) Medical equipment meeting the criteria of Group 1 may bid for Group 1 and Groups 2, 3, 4, 5, and 6;

b) Medical equipment meeting the criteria of Group 2 may bid for Group 2 and Groups 3, 4, 5, and 6;

c) Medical equipment meeting the criteria of Group 3 may bid for Group 3 and Groups 4, 5, and 6;

d) Medical equipment meeting the criteria of Group 4 may bid for Group 4 and Groups 5 and 6;

đ) Medical equipment meeting the criteria of Group 5 may bid for Group 5 and Group 6;

e) Medical equipment that does not meet the criteria of Groups 1, 2, 3, 4, and 5 may only bid for Group 6.

Article 5. Report on the Implementation of Medical Equipment Tendering

1. After the bidder selection results are approved, within twenty days, the head of the healthcare facility is responsible for reporting the bidder selection results according to the form in Appendix II issued together with this Circular for specialized medical equipment and according to the form in Appendix III issued together with this Circular for other medical equipment to the authority approving the bidder selection plan and the Ministry of Health (Department of Planning and Finance).

2. Within ten working days from the date of receiving the report on the bidder selection results from healthcare facilities, the authority approving the bidder selection plan and the Ministry of Health (Department of Planning and Finance) is responsible for publicly posting on the electronic portal.

3. When a bidder violates during the tendering process for medical equipment supply, the healthcare facility is responsible for reporting to the competent authority to handle according to the laws on tendering and handling violations. The violation handling result must be sent to the Ministry of Health (Department of Planning and Finance) within five working days from the date of the violation result according to the form prescribed in Appendix V issued together with this Circular for consolidation and publication, serving as a basis for units to consider evaluating and selecting bidders in subsequent rounds.

Chapter II

BIDDER SELECTION PLAN

Article 6. Preparation of tender selection plans for medical equipment

In addition to complying with the provisions of the Law on Bidding No. 43/2013/QH13, Decree No. 63/2014/NĐ-CP, and related bidding guidance documents, the preparation of tender selection plans must also comply with the following additional regulations:

1. The tender selection plan shall be prepared annually or when there is a need to organize the selection of contractors based on the following grounds:

a) For tenders to purchase specialized medical equipment: The budget estimate for procurement shall be based on the allocated funds and the approved standards for specialized medical equipment as stipulated in Circular No. 08/2019/TT-BYT dated May 31, 2019, issued by the Minister of Health guiding the standards and quotas for the use of specialized machinery and equipment in the healthcare sector (hereinafter referred to as Circular No. 08/2019/TT-BYT).

b) For tenders to purchase other medical equipment: The budget estimate for procurement shall be based on available funds, actual purchases and usage of medical equipment in the previous year, and anticipated needs for medical equipment in the current year to prepare the plan.

2. The name of the tender package must reflect the nature, content, and scope of work of the tender package; it must be consistent with the content stated in the project and procurement budget. In cases where the tender package consists of multiple distinct parts, the tender selection plan must specify the basic content of each part.

Article 7. Guidelines for preparing tender invitation documents and request documents for medical equipment

In addition to complying with the provisions of the Law on Bidding No. 43/2013/QH13, Decree No. 63/2014/NĐ-CP, and related bidding guidance documents, when preparing tender invitation documents and request documents, the unit must:

1. Implement the classification of medical equipment according to the provisions of Article 4 of this Circular, wherein a type of medical equipment may be divided into one or more different groups as appropriate to professional requirements, usage needs, and funding sources.

2. Based on professional requirements and usage needs, establish technical requirements for medical equipment. Specifically, for specialized medical equipment as defined in Circular No. 08/2019/TT-BYT, the establishment of technical requirements for medical equipment shall be carried out according to the provisions set forth in Appendix IV attached to this Circular.

3. Require bidders to provide certificates of acceptance for medical equipment meeting the conditions for sale, serial numbers, or import permits corresponding to the tendered medical equipment, in accordance with the provisions of Government Decree No. 36/2016/NĐ-CP dated May 15, 2016, on the management of medical equipment, amended and supplemented by Government Decrees No. 169/2018/NĐ-CP dated December 31, 2018, and No. 03/2020/NĐ-CP dated January 1, 2020.

4. Specify the responsibilities of the contractor regarding handover, installation, training, and guidance on the use of medical equipment to ensure effectiveness, quality, and safety for patients and users.

5. Not impose requirements or guidelines that would compel bidders to offer imported goods when domestically produced or assembled goods meet the quality, quantity, price requirements, and must comply with the provisions on preferential content (criteria, methods for calculating preferential value, and supporting documents) under the laws on bidding.

6. Specify that medical equipment participating in the tender must be supplied by one of the following organizations or individuals:

a) Organizations or individuals who are the owners of the serial number of the medical equipment;

b) Organizations or individuals authorized by the owner of the serial number of the medical equipment;

c) Organizations or individuals authorized by the organizations or individuals specified in point b of this Clause;

d) Organizations or individuals authorized by the owner of the medical equipment;

đ) Organizations or individuals authorized by the organizations or individuals specified in point d of this Clause;

e) Organizations or individuals authorized by the organizations or individuals specified in point đ of this Clause;

g) Organizations or individuals named on the import permit for medical equipment;

h) Organizations or individuals authorized by the organizations or individuals specified in point g of this Clause;

Such authorization must comply with the provisions of civil law.

Article 8. Bid Package Price

1. The bid package price is established based on the total investment amount or budget estimate for the project. The bid package price is the total value of the bid package, accurately accounting for all costs to implement the bid package, including contingency costs, fees, charges, and taxes.

2. In cases where the bid package is divided into multiple parts, in addition to recording the total value of the bid package, each part must clearly list the item description, quantity, unit, unit price, and total value of that part in accordance with Clause 1 of this Article.

3. When preparing the budget estimate for the bid package price, healthcare facilities must refer to the winning bid prices of medical equipment published within the last twelve months on the website of the competent authority approving the procurement plan and the Ministry of Health to establish the unit price for each piece of medical equipment, specifically as follows:

a) The planned price of medical equipment shall not be higher than the winning bid price of that medical equipment that has been implemented or announced. If the price is higher, it must be explained and detailed.

b) For medical equipment without published winning bid prices, when establishing and determining the bid package price in the procurement plan, reference must be made to the guidelines provided by Law on Bidding No. 43/2013/QH13, Decree No. 63/2014/NĐ-CP, and related bidding guidance documents regarding the construction of bid package prices to ensure they are consistent with market prices for such medical equipment at the time of drafting the procurement plan.

Article 9. Approval Plan Procurement File

In addition to complying with the provisions of Law on Bidding No. 43/2013/QH13, Decree No. 63/2014/NĐ-CP, and related bidding guidance documents, the minimum contents of the file requesting approval of the procurement plan include:

1. Document presenting the procurement plan for approval.

2. Relevant legal documents and files.

3. Summary report on the results of implementing the procurement plan, the situation of using medical equipment in the previous year (if applicable), and a brief explanation of the procurement plan being presented for approval.

4. Documents serving as the basis for formulating the procurement plan for providing medical equipment as stipulated in Clause 1 of Article 6 of this Circular.

5. Minutes of the meeting of the hospital's scientific council agreeing on the contents of the plan, needs, list, quantity, technical requirements, and budget estimate for proposed medical equipment investments, with full participation from representatives of relevant departments, functional units, and users of medical equipment.

6. Documents used as the basis for constructing the bid package price for medical equipment as stipulated in Article 8 of this Circular.

Chapter III

IMPLEMENTING PROVISIONS

Article 10. Effective Date

This Circular takes effect from September 1, 2020.

Article 11. Transitional Provisions

1. For procurement plans approved before the effective date of this Circular, they shall continue to be implemented according to the plan already approved by the competent authority and must report the implementation results in accordance with Article 5 of this Circular.

2. For procurement plans submitted to the competent authority before the effective date of this Circular but not yet approved, they may continue to organize reviews and approvals if the plan contents do not conflict with the provisions of this Circular and must report the implementation results in accordance with Article 5 of this Circular.

Article 12. Implementation Organization

The heads of healthcare facilities are responsible for:

1. Directing the Medical Equipment Supply Department or the medical equipment management department to compile needs, develop lists, plans, and budget estimates for purchasing medical equipment, and advise the facility's head on configuration, technical features, usage features, standards, technology generation, and conditions for ensuring safety, staff training, technical infrastructure installation to put equipment into operation, meeting professional requirements, and maximizing investment effectiveness.

2. Based on annual procurement quotas, the needs of medical equipment from departments, functional units, and specialized units, the recommendations and advice of the Medical Equipment Supply Department or the medical equipment management department, and the opinions of the hospital's scientific council, to decide and take responsibility for building the medical equipment usage plan for the unit.

During the implementation, if there are any difficulties, please report them to the Ministry of Health for consideration and resolution./.