Công văn 5888/BYT-TB-CT

The procurement of medical devices at public health facilities currently complies with the regulations laid down in the Law on Bidding, Decree No. 63/2014/ND-CP and relevant guiding documents on bidding, and guidelines of the Ministry of Finance provided in the Circular No. 58/2016/TT-BTC dated March 29, 2016.

On July 10, 2020, the Ministry of Health promulgated the Circular No. 14/2020/TT-BYT on medical device bidding at public health facilities (hereinafter referred to as “the Circular No. 14/2020/TT-BYT”). This Circular has been effective since September 01, 2020.

In order to implement the Circular No. 14/2020/TT-BYT in an accurate and uniform manner, the Ministry of Health hereby provides guidance on certain issues. To be specific:

1. Scope

a) The Circular No. 14/2020/TT-BYT applies to bidding for procurement of products and goods that are medical devices.

In order to confirm a product or goods is a medical device, it is required to refer to the definition of “medical device” provided in Clauses 1 and 2 Article 1 of the Government's Decree No. 36/2016/ND-CP amended by the Decree No. 169/2018/ND-CP.

b) The Circular No. 14/2020/TT-BYT does not apply to bidding for procurement of products and goods that are not medical devices. The bidding of such products and goods shall comply with regulations of the Law on Bidding, Decree No. 63/2014/ND-CP and relevant guiding documents on bidding.

In order to confirm a product or goods is not a medical device, it is required to refer to the definition of “medical device” provided in Clauses 1 and 2 Article 1 of the Government's Decree No. 36/2016/ND-CP amended by the Decree No. 169/2018/ND-CP.

E.g. Products intended for use in testing procedures which are currently RUO (research use only) or LUO (laboratory use only) products, etc. are not medical devices;

c) The Circular No. 14/2020/TT-BYT does not apply to the procurement of products and goods that are materials, software, accessories (e.g. ultrasound transducers, X-ray tubes, etc.) and medical gas exempt from registration and import licensing under Clause 13 Article 68 of the Government’s Decree No. 36/2016/ND-CP amended by the Decree No. 169/2018/ND-CP.

d) The Circular No. 14/2020/TT-BYT applies to bidding for procurement of products and goods that are medical devices using public investment capital.

2. Classification of medical devices

a) According to Clause 1 Article 7 of the Circular No. 14/2020/TT-BYT, a type of medical device may be classified into one or more groups. A type of medical device shall be classified following the steps below:

- According to the professional requirements and demand for medical devices, a health facility shall make publicly available its demand for procurement of medical devices in order for medical device traders to provide information about:

+ Types, configurations and specifications of the medical devices;

+ Specific group of each type;

+ Specific price for each type.

- According to the abovementioned information, the health facility shall:

+ Make a list of needed medical devices by group.

+ According to the abovementioned list and prices published online by the traders, select one or more groups to prepare a contractor selection plan that is suitable for its professional requirements and demand and within its budget.

According to the Law on Bidding, Decree No. 63/2014/ND-CP and Circular No. 19/2015/TT-BKHDT, request for proposals and bidding documents must be conformable with the approved contractor selection plan, therefore, the classification is required upon preparing a contractor selection plan.

b) Regarding classification of medical devices that are systems of multiple medical devices:

- If medical devices belong to the same owner, are expected to be used in combination to serve the same purpose and are compatible when used in a system but every single medical device in the system is classified into different groups instead of the same group, the regulations set out in the Circular No. 14/2020/TT-BYT shall not apply.

Example of a system of multiple medical devices: endoscopic surgical system (light source, image processor, camera, etc.), electric scalpels, CO2 pumps, arthroscopy shavers, etc. in which each medical device in the same system is classified into different groups instead of the same group.

- If medical devices are systems and classified into the same group, the regulations set out in the Circular No. 14/2020/TT-BYT shall apply.

E.g. A contract package for magnetic resonance imaging system, CT-Scanner computed tomography system, etc., medical devices in such system are classified into the same group.

c) The country of origin of a medical device shall be determined according to one of the documents specified in Clause 2 Article 4 of the Circular No. 14/2020/TT-BYT. Attention shall be paid to the following:

- The requirements applied to the documents specified in Point c Clause 2 Article 4 of the Circular No. 14/2020/TT-BYT are specified in Points b and g Clause 2 Article 23 of this Decree No. 169/2018/ND-CP.

- Regarding specimen of the Certificate of Free Sale: health facilities may refer to the Certificates of Free Sale published at https://dmec.moh.gov.vn.

3. Organizations and individuals providing medical devices

The Circular No. 14/2020/TT-BYT stipulates that offered medical devices must be provided by one of the organizations or individuals specified in Clause 6 Article 7, including owner of the medical devices, holder of marketing authorization number of the medical devices, holder of the license to import medical devices and authorized organizations and individuals, and that the authorization shall comply with civil laws.

Some examples:

a) A medical device bid for by Company B in Vietnam which is authorized by Company A in Vietnam which is authorized by a company in Singapore which is authorized by the owning company in America.

Hence, the following entities are entitled to bid for supply of medical devices:

- Company in Singapore because of its compliance with Point d Clause 6 Article 7 of the Circular No. 14/2020/TT-BYT;

- Company A in Vietnam because of its compliance with Point dd Clause 6 Article 7 of the Circular No. 14/2020/TT-BYT;

- Company B in Vietnam because of its compliance with Point e Clause 6 Article 7 of the Circular No. 14/2020/TT-BYT;

b) A medical device bid for by Company B at public health facilities as authorized by Company A in Vietnam which is the holder of the import license.

Hence, the following entities are entitled to bid for supply of medical devices:

- Company A in Vietnam because of its compliance with Point g Clause 6 Article 7 of the Circular No. 14/2020/TT-BYT;

- Company B in Vietnam because of its compliance with Point h Clause 6 Article 7 of the Circular No. 14/2020/TT-BYT.

Difficulties that arise during the implementation of this Official Dispatch should be reported to the Ministry of Health (the Department of Medical Equipment and Construction), 138A Giang Vo Street, Ba Dinh District, Hanoi City, telephone number: 024.62732272 and email: [email protected] for consideration and resolution./.