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MINISTRY OF
HEALTH
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SOCIALIST
REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
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No. 15/BYT-TB-CT
Re. implementation of the Government’s
Decree No. 169/2018/ND-CP dated December 31, 2018.
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Hanoi, January 2,
2019
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To Representative
offices of medical equipment importing, manufacturing and trading plants and
enterprises (hereinafter referred to as entity or entities)
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1. The Decree No. 169/2018/ND-CP amends and
supplements regulations pertaining to management of medical equipment as
follows:
- Interpretation of medical equipment terms;
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- Requirements applied to medical equipment
classification, manufacturing and trading establishments;
- Procedures for declaration and registration for
marketing authorization and import of medical equipment;
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- Management and operation of medical equipment;
- Implementation organization.
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- Permits for import of medical equipment
classified into group B, C and D which were granted in 2018 have been invalid
from December 31, 2018 while import permits granted in 2019 will continue its
effect till end of December 31, 2019.
- With regard to medical equipment which are
in-vitro diagnostic biological products already obtaining marketing
authorization certificates under the provisions of the 2005 Law on Pharmacy and
other documents guiding the implementation of this Law, previously-granted
marketing authorization numbers will be valid until the validity period
specified on each marketing authorization certificate ends. In particular, if
numbers of marketing authorization for in-vitro diagnostic biological products
expire after January 1, 2019 and before December 31, 2019, they may continue to
be in use till the end of December 31, 2019.
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If medical equipment which are imported in-vitro
diagnostic biological products have applications for marketing authorization
within the period from January 1, 2019 to end of December 31, 2019, permits for
import of these products will be awarded in accordance with the 2005 Law on
Pharmacy and will be valid till end of December 31, 2019.
- If chemicals, pest control and antibacterial
products for domestic and medical uses which serve the sole purpose of
disinfecting medical equipment have already been granted marketing
authorization certificates which expire after July 1, 2016 and before January
1, 2019, these certificates will continue to be used till end of December 31,
2019.
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- All applications for declaration of applied
standards of group-A medical equipment have been received since January 1, 2017
and the notes of acknowledgement of such application have been valid since July
1, 2017; all applications for registration of marketing authorization for
group-B, C and D medical equipment have been received since July 1, 2017 and
marketing authorization numbers of medical equipment have been valid since
January 1, 2020.
- Medical equipment classification bodies shall be
responsible to finish publishing results of classification of medical equipment
already issued before December 31, 2018 on the website of the Ministry of
Health at the address: www.dmec.moh.gov.vn before April 1, 2019.
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- Holders of marketing authorization numbers must
review results of classification of medical equipment in accordance with clause
2 of Article 4 in the Decree and must report to the Ministry of Health prior to
July 1, 2019.
- ASEAN Common Submission Dossier Template will be
applied from July 1, 2020.
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The Ministry of Health would like to request entities
to study and undertake the implementation of provisions of the Decree. In the
course of implementation, if there is any query and difficulty that arises,
please contact the Ministry of Health (Department of Medical Equipment and
Construction) via the telephone number: 024.62732272, email: [email protected] or
[email protected] to seek its timely review and solution. Any blockage in
business, manufacturing and import activities of entities that may arise at the
aforestated transitional dates must be prevented./.
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PP. MINISTER
DEPUTY MINISTER
Nguyen Viet Tien