|
MINISTRY OF
HEALTH
-------
|
SOCIALIST
REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
---------------
|
|
No. 14/BYT-TB-CT
Re. implementation of the Government’s
Decree No. 169/2018/ND-CP dated December 31, 2018.
|
Hanoi, January 2,
2019
|
To Ministry
of Finance (General Department of Customs)
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;
...
...
...
Bạn phải
đăng nhập hoặc
đăng ký Thành Viên
TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
- 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.
- Group-A medical equipment with notes of
acknowledgement of application documentation for declaration of applied
standards, issued by the Department of Health, may be imported depending on
demands without being subject to any quota and having to enclose the written
confirmation of medical equipment given by the Ministry of Health before
customs clearance. Medical equipment not in the list of medical equipment that
require import permits and already classified as group-B, C, and D medical
equipment by classification bodies published by the Ministry of Health on its
website may continue to be imported till end of December 31, 2019, depending on
demands, without being subject to any quota and having to enclose the written
confirmations of medical equipment by the Ministry of Health before customs
clearance.
- 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 end of the expiry date specified
on each marketing authorization certificate. 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
disinfection of 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
marketing authorization certificates. In particular, if marketing authorization
certificates expire after the effective date of the Decree and before December
31, 2019, these certificates may continue to be in use till the end of December
31, 2019.
...
...
...
Bạn phải
đăng nhập hoặc
đăng ký Thành Viên
TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
- 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.
- 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 you to
study, provide Customs Departments of cities and provinces with instructions
and directions for implementation 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: dmec@moh.gov.vn or
vuttbctyt@gmail.com for collaboration purposes.
Thanks for your collaboration./.
...
...
...
Bạn phải
đăng nhập hoặc
đăng ký Thành Viên
TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66