Currently, the bidding regulations for the procurement of medical equipment are implemented in accordance with the provisions of the Law on Bidding, Decree No. 63/2014/ND-CP and other related bidding documents and guidelines of the Ministry of Finance in Circular No. 58/2016/TT-BTC on procurement to maintain regular operations of State agencies.

However, in the process of bidding for medical equipment at medical facilities, there are still a number of difficulties and shortcomings because the medical equipment item is a specific item but the bidding is required as common goods. Circular 14/2020 / TT-BYT additional regulations and adjustments to address these shortcomings.

 

Circular No. 14 regulates the following:

1.   1. Group classification and participation in groups of bidding packages for medical devices;
2.   2. Report on implementation of bidding for medical devices;
3.   3. Preparation of bid invitation dossier and dossier of requirements;
4.   4. Plan of selecting contractors to purchase medical devices.

There are some information which need to pay attention at.

First of all, only listing below organizations or individuals can apply for bidding.

1.   1. The holder of medical device registration number.
2.   2. The organizations or individuals are authorized by the holder of registration number.
3.   3. The organizations or individuals are authorized by the organization/individuals mentioned in this point 2.
4.   4.The legal manufacture of medical device.
5.   5.The organizations or individuals are authorized by the legal manufacture.
6.   6.The organizations or individuals are authorized by the organization/individuals mentioned in this point 5.
7.   7.The holder of import permit.
8.   8.The organizations or individuals are authorized the holder of import permit.

Secondly, here are required documents for bidding

1.   1. The receipt number of Eligible Trading Medical Devices
2.   2. Registration number or import permit number of medical devices
3.   3. Additional documents based on the group that medical devices belonged in.

5. In more detail of group classification and participation in groups of bidding packages for medical devices, a bidding package may contain one or several categories of medical devices, each of which may be divided as follows:

6. Group	CFS		Made in
   	Reference countries*	Vietnam	Reference countries or Vietnam	Vietnam	Other countries
   1	>2 CFS		X
   2	>2 CFS				X
   3	>1 CFS		X
   4	>1 CFS				X
   5		X		X
   6	Medical devices other than those specified in items 1, 2, 3, 4 and 5 as stated above.

* the reference countries include EU countries, the US, Japan, Australia and Canada.

A bidder may apply for one or several groups whose criteria are fully satisfied by their products, provided the bidding price must be consistent among all groups (group classification does not apply to medical devices that which is a system has multiple individual medical devices).

In conclusion, the medical device companies should pay particular attention to the requirement of group classification in order to participate in the bidding packages of public health establishments.

 

References:
: Circular No. 14/2020/TT-BYT Regulate a number of aspects in bidding for medical equipment at public medical establishments