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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)
On December 31, 2018, the Government promulgated
the Decree No. 169/2018/ND-CP amending and supplementing certain Articles of
the Government’s Decree No. 36/2016/ND-CP dated May 15, 2016 on management of
medical equipment (hereinafter referred to as Decree No. 169/2018/ND-CP), which
entered into force from the signature date.
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;
- Classification of medical equipment;
- Requirements applied to medical equipment
classification, manufacturing and trading establishments;
- Procedures for declaration and registration for
marketing authorization and import of medical equipment;
- Medical equipment assessment and calibration
activities;
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- Implementation organization.
2. The Decree No. 169/2018/ND-CP amends and
supplements transitional provisions in Article 68 of the Decree No.
36/2016/ND-CP, including the following noticeable contents:
- 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.
If medical equipment which are in-vitro diagnostic
biological products have applications for marketing authorization submitted in
accordance with the 2005 Law on Pharmacy before January 1, 2019, these
applications will be processed as per the 2005 Law on Pharmacy.
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.
- If domestically-manufactured medical equipment
has already obtained marketing authorization certificates, marketing
authorization numbers will be valid till end of the expiry date specified on
each marketing authorization certificate. In particular, if marketing
authorization certificates expire after the effective date of this Decree and
before December 31, 2019, these certificates may continue to be in use till the
end of December 31, 2019.
- 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.
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- All certificates of completion of training in
classification of medical equipment which were granted before December 31, 2018
are valid for only 3 years from the signature date;
- 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.
- Medical gas manufacturing establishments must
finish applying the quality control system ISO 9001 or equivalent from January
1, 2020. Other establishments must continue to comply with provisions laid down
in the Decree No. 36/2016/ND-CP.
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./.
PP. MINISTER
DEPUTY MINISTER
Nguyen Viet Tien