Vietnam MOH has indicated in their note 742 on 29th Jan 2021 that they plan to release approvals in 2021. See more info here.
MINISTRY OF HEALTH
——-
SOCIALIST REPUBLIC OF VIETNAM
Independence – Freedom – Happiness
—————
No: 724 / BYT-TB-CT Regarding the
application for registration of free sale of
medical equipment
Hanoi, January 29, 2021
To: Registrars of free sale of medical equipment
( hereinafter referred to as the units )
Pursuant to the Government’s Decree No. 36/2016 / ND-CP dated May 15, 2016 on the management of medical
equipment ( hereinafter referred to as Decree No. 36/2016 / ND-CP ), Decree No. 169/2018 / ND-CP dated
December 31, 2018 of the Government amending and supplementing a number of articles of Decree No. 36/2016 /
ND-CP ( hereinafter referred to as Decree No. 169/2018 / ND- CP ), Decree No. 03/2020 / ND-CP dated January
1, 2020 of the Government amending and supplementing Article 68 of the Government’s Decree No. 36/2016 / NDCP
dated May 15, 2016 on Medical equipment management has been amended and supplemented in Decree
No. 169/2018 / ND-CP ( hereinafter referred to as Decree No. 03/2020 / ND-CP ).
On December 25, 2020, the Ministry of Health held a meeting with representatives of the units on contents related to
the application for registration of free circulation of medical equipment on the online public service system. medical
equipment management dmec.moh.gov.vn (hereinafter referred to as the https://dmec.moh.gov.vn system) to speed
up the appraisal and issue number of circulation of medical equipment . On December 31, 2020, the Ministry of
Health issued Official Letter No. 7395 / BYT-TB-CT guiding units to prepare and submit medical equipment
registration dossiers strictly according to regulations in order to limit the number of times the units must submit
additional dossiers. Based on the opinions of the units and to support the completion of the submitted medical
equipment registration dossiers, accelerate the dossier appraisal, avoid errors leading to an extension of time. During
the time of dossier appraisal, the Ministry of Health requests the units to urgently coordinate the implementation of
the following contents:
1. Based on the need to import or trade in medical equipment and the ability to supplement valid legal papers and
technical documents of the application for registration of free sale of medical equipment, request an application. you
send the list of applications for registration of free circulation of medical equipment for pre-evaluation by batches
(from now to June 2021 and from June 2021 to December 2021) to the Ministry of Health Review, support and settle
the documents submitted by the unit on the system https://dmec.moh.gov.vn .
2. Study the provisions of Article 25 and Article 26 of Decree No. 169/2018 / ND-CP and review the circulation
registration dossiers submitted on the system https://dmec.moh.gov.vn : In case the application is eligible for the
quick issue of registration number or the application is ineligible for the registration number, the unit shall send the list
of documents to the Ministry of Health for support and adjustment process according to regulations.
The Ministry of Health informs the units to study, review, promptly implement and report to the Ministry of Health (the
Department of Medical Equipment and Works), 138A Giang Vo, Ba Dinh, Hanoi, Telephone number : 024.62732272
to be considered and resolved./.
Recipients:
– As above (to show / show);
– Minister (to report);
– TT Truong Quoc Cuong (to report);
– Save: VT, TB-CT.
TL. MINISTER
OF HEALTH
EQUIPMENT AND MEDICAL WORKS
Nguyen Minh Tuan
