In July 2020, the Vietnamese Ministry of Health published a circular concerning the new procedure for medical device tenders in public health facilities. This circular, entering into force on the 1st of September 2020, covers different aspects of the bidding process and introduces a new classification for medical device bidding packages divided in 6 groups depending on the manufacturing country and the number of Free Sales Certificates (also known as Certificates of Free Sales or FSC) issued by specific countries.
The reference countries mentioned in the circular are:
– European countries (27 EU Member States + the United Kingdom and Switzerland)
– United States of America
– Japan
– Australia
– Canada
In order to be considered a part of a specific classification group, the medical device must fulfils both requirements described in the table below:
Is important to clarify that a bidder may apply for one or several groups whose criteria are fully satisfied by their products. For example, a bidder whose devices satisfy the criteria of Group 2 may apply to Groups 2, 3, 4, 5, 6.
For this reason, obtaining 1 or 2 Free Sales Certificates becomes crucial for those manufacturers that, for tender purposes, want to be able to participate in several groups.
If you are a medical device manufacturer bidding in Vietnamese public health establishments, and you want to increase the number of groups for which you can apply, our expert consultants and our Obelis International Officers can assist you in obtaining Free Sales Certificates in the shortest time.
In more than 30 years of activity, Obelis successfully supported many clients expanding their markets worldwide. Contact us now to discover more about our services!
Valeria Piattelli
Regulatory Affairs Department
21/09/2020
Are you a manufacturer of medical devices and find yourself in one of the groups impacted by these changes? Are you unsure as to what the impact on your business will be?
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