In brief

The Ministry of Health (“MOH“) has issued Circular No. 14/2020/TT-BYT dated 10 July 2020 (“Circular No. 14“), which will regulate various aspects of the bidding process of medical devices for public health establishments. This circular will take effect on 1 September 2020.

 Circular No. 14 regulates the following:

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

Of these four items, the medical device industry is paying particular attention to the requirement of group classification in order to participate in the bidding packages. This is because it is the first time medical devices are divided into groups for tender purpose. In addition, not many companies in the industry can satisfy a requirement of obtaining two Certificate of Free Sale (“CFS“) in order to participate in group 1 as required by Circular No. 14.


Contents

In more detail

Requirement of group classification and participation in groups of bidding packages for medical devices

Under Circular No. 14, the reference countries include EU countries, the US, Japan, Australia and Canada.

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

  1. Group 1: medical devices that are both:
  • Granted the CFS by at least two reference countries; and
  • Made in a reference country or Vietnam.
  1. Group 2: medical devices that are both:
  • Granted the CFS by at least two reference countries;
  • Are not made in any reference country or Vietnam.
  1. Group 3: medical devices that are both:
  • Granted the CFS by at least one reference country;
  • Made in a reference country or Vietnam.
  1. Group 4: medical devices that are both:
  • Granted the CFS by at least one reference country;
  • Are not made in any reference country or Vietnam.
  1. Group 5: medical devices that are both:
  • Granted a marketing authorization number in Vietnam;
  • Made in Vietnam.
  1. Group 6: medical devices other than those specified in items 1, 2, 3, 4 and 5 as stated above.

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 form components of multiple individual medical devices).

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