The official letter 3600/BYT-TB-CT implement the regulation in Decree 36/2016/NĐ-CP dated May 15, 2016 of Government relating to management of medical device

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The official letter 3600/BYT-TB-CT
The official letter 3600/BYT-TB-CT
The official letter 3600/BYT-TB-CT implement the regulation in Decree 36/2016/NĐ-CP dated May 15, 2016 of Government relating to management of medical device
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The official letter 3600/BYT-TB-CT implement the regulation in Decree 36/2016/NĐ-CP dated May 15, 2016 of Government relating to management of medical device

Ministry of Health


No. 3600/BYT-TB-CT

Re: implement the regulation in Decree 36/2016/NĐ-CP dated May 15, 2016 of Government relating to management of medical device

Socialist Republic of Vietnam

Independence – Freedom – Happiness

———

Hanoi, June 23, 2017

URGENT

To: Representative offices, importers, trading medical device organizations
(acronym: organization)

May 15, 2016, Prime Minister has issued Decree 36/2016/NĐ-CP relating to Management of medical device (acronym: Decree 36/2016/NĐ-CP) had effect on July 01, 2016. Following that, there are important changes in management of medical device, details as follow:

Firstly, all medical device must be classified for declaration of applicable standard or registration for free sale certificate.


In case there is difficulty, queries, please contact MOH (Division of medical equipment and construction) for consideration and solution: Tel. no: 024.62732272, email: vuttbctyt@gmail.com

 

Director of DMEC

Signed and stamped

Nguyen Minh Tuan

The official letter 3600/BYT-TB-CT implement the regulation in Decree 36/2016/NĐ-CP dated May 15, 2016 of Government relating to management of medical device

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