MINISTRY
OF HEALTH
-------- |
SOCIALIST
REPUBLIC OF VIETNAM
Independence – Freedom – Happiness ----------------------- |
No.: 1275/BYT-TB-CT
Re: Request for compliance with the national single window and the Circular No. 30/2015/TT-BYT of the Ministry of Health |
Hanoi,
March 11, 2016
|
To: Representative offices, importers and
traders in medical equipment
(referred to as concerned entities)
(referred to as concerned entities)
Pursuant
to the Circular No. 30/2015/TT-BYT dated October 12, 2015 of the Ministry of
Health providing for import of medical equipment.
Pursuant
to the Decision No. 5007/QD-BYT dated November 23, 2015 of the Minister of
Health applying ASEAN Single Window Mechanism and Vietnam National Single
Window Mechanism to the execution of administrative procedures for issuance of
permits for import of medical equipment.
As of
November 30, 2015, the Ministry of Health has got the cooperation with the
General Department of Vietnam Customs to develop the Vietnam National Single
Window Mechanism for carrying out administrative procedures for issuance of
permits for import of medical equipment, organize two conferences for
disseminating the Circular No. 30/2015/TT-BYT and providing training for
importers in applying the Vietnam National Single Window Website to execute
administrative procedures for issuance of import permits in Hanoi City and Ho
Chi Minh City, and promulgate written guidance on use of the Vietnam National
Single Window Website (address: https://vnsw.gov.vn) including registering for
accounts, applying procedures for issuance of import permits and registering
for digital signatures.
By means
of applying the single window customs software to execute administrative
procedures for issuance of medical equipment, the importers have been
facilitated and supported in carrying out the declaration and application for
import permits such as: accessing information and updating application status
in a prompt way, saving time and costs, etc. Especially, it’s more convenient
for geographically remote importers such as those located in Ho Chi Minh City
and southern Vietnam. Additionally, period for issuing import permits is
shortened.
During
the implementation of single window mechanism, many entities have carried out
research, and strictly and sufficiently complied with guidance and regulations
of the Ministry of Health. However, many entities still do not pay attention to
research, updating and compliance with new regulations of the Circular No.
30/2015/TT-BYT and relevant regulations and guidance on application and use of
software in the national single window website resulting in many difficulties
in the application processing job and software efficiency.
For the
purpose of assisting relevant entities in grasping and implementing
disseminated regulations and guidance, the Ministry of Health (Department of
Medical Equipment and Health Facilities) does announce and request as follows:
1. Importers are responsible for
carrying out detailed research on regulations and requirements on the
application and procedures for issuance of import permits as regulated in the
Circular No. 30/2015/TT-BYT, the Official Dispatch No. 9228/BYT-TB-CT dated
November 25, 2015 and the Official Dispatch No. 102/BYT-TB-CT dated January 08,
2016 of the Ministry of Health providing for the execution of import procedures
according to single window mechanism and the implementation of the Circular No.
30/2015/TT-BYT, and guidance on account registration, guidance on applying
procedures for issuance of import permits and registering for digital
signatures which have been published on the Vietnam National Single Window
Website for avoiding correction or supplementation of documents due to failure
to carry out research on disseminated and trained regulations and guidelines.
2. As for the application for
import permit: The importer shall bear responsibility for the sufficiency,
validity, accuracy and legal requirements on such application as regulated in
the Circular No. 30/2015/TT-BYT, and also bear responsibility for retaining
submitted application for the purpose of tracing their sources, origin and
ensuring quality management of medical equipment as regulated by laws.
3. Importers must strictly comply
with regulations and provide sufficient contents concerning technical documents
describing models of imported medical equipment which must be certified by
affixing the importers’ seals as regulated in the Annex No. IV of the Circular
No. 30/2015/TT-BYT.
4. For the purpose of avoiding the
importers' correction and supplementation of documents due to errors in
software-added declaration, the Ministry of Health promulgates under this
Official Dispatch the guidelines and notes for using the software on the
Vietnam National Single Window Website in order that relevant entities can
grasp and implement relevant regulations (guidelines are attached herewith).
Relevant
entities are requested to strictly implement the aforesaid contents.
Difficulties that arise during the implementation of this Official Dispatch
must be reported to the Ministry of Health (via Department of Medical Equipment
and Health Facilities) at telephone number: 04.62732272 or email:
vuttbctyt@gmail.com.
BY
ORDER OF MINISTER OF HEALTH
DIRECTOR GENERAL OF DEPARTMENT OF MEDICAL EQUIPMENT AND HEALTH FACILITIES Nguyen Minh Tuan |
GUIDELINES
(Attached to the Official Dispatch
No.:………./BYT-TB-CT dated March……, 2016 of the Ministry of Health)
1. Account
information:
The
following information must be sufficiently and exactly specified: tax code,
address, representative, enterprise's name in Vietnamese and abbreviated name
(sufficiently specify in capital letters) in conformity with the contents
stated in the enterprise’s business registration certificate/investment
certificate.
2. Information
included in the application for import permit:
- Type of application: Select
correct form of the application for import permit: new issuance, amendment or
renewal.
- Headings of equipment: Based on
medical equipment requiring import permit, select correct headings of such
equipment according to the List of medical equipment stated in Annex I of
Circular No. 30/2015/TT-BYT.
- Name of equipment: Information
concerning each type of imported medical equipment must be specified in
Vietnamese letters in lower case according to the List of medical equipment
stated in Annex I of the Circular No. 30/2015/TT-BYT. It is not allowed to use
an English name, trade name, brand’s name, or list code or model of product, or
aggregate different names of imported medical equipment.
Examples:
Correct:
“Máy Điện não”;
Wrong:
“Máy Điện não EEG”, “Máy Điện não VIRGO-24”, “Máy Điện não
(Electroencephalograph)”, “Máy Điện não và Máy Điện cơ”, “Máy Đo và phân tích Điện não”.
- Model It’s requested to provide
sufficient information in conformity with the contents included in the
certificate of free sale. Name of imported medical equipment shall not be
specified in the description of equipment model. In case many models of the
same type of imported medical equipment are stated in the certificate of free
sale, information concerning such models must be sufficiently specified and
separated from each other by a semicolon “;”.
Notes:
Product models are put into attached annex in case the imported medical
equipment includes product models or HS codes, or the imported medical
equipment is a system that includes many parts which cannot be listed in the
part of model-concerned information of the application for import permit.
- Manufacturer or country thereof:
Information must be exactly and sufficiently specified according to the
contents stated in certificate of quality; manufacturer and country thereof
shall be separated by a comma “,”. Examples: Correct: Siemens, Germany; Wrong:
“Siemens/ Germany” or “Siemens/ Nhật Bản, Japan”.
- Owner or country thereof:
Information must be exactly and sufficiently specified according to the
contents stated in certificate of free sale and certificate of quality; the
manufacturer and thereof shall be separated by a comma “,”.
- Distributor or country thereof
(if any): Is an entity in foreign country who is authorized by the owner (if
any) to carry out the distribution of medical equipment. The importer must
exactly and sufficiently declare information in conformity with the contents
stated in certificate of free sale and the owner’s power of attorney; not
specify information concerning distributors in Vietnam or may leave such part
blank if there is no information of distributor.
Examples:
Correct:
Gold Lite Pte Ltd, Singapore;
Wrong: “Công ty TM&DVKT LT, Việt Nam”.
- Duration of power of attorney:
Duration of power of attorney must be correctly and exactly specified according
to the duration stated in the power of attorney which is included in the
application for import permit. In case the owner grants authorization through
many different entities, the duration of power of attorney shall apply the
latest duration of one of powers of attorney.
3. Attached
files:
- Documents included in the
application for import permit of medical equipment shall be scanned in color
form after all requirements regulated in the Circular No. 30/2015/TT-BYT have
been performed. In case of notarized document, all pages of such document must
be scanned with the notary’s stamp affixed in each page or the notary’s seal
affixed on adjoining edges of all pages.
- Names of attached files must show
contents as stated the application for import permit. Examples: Giay chung nhan
CFS_model A, Giay chung nhan CFS_model B, C, D, Giay chung nhan ISO 13485, Giay
uy quyen, Giay dang ky DN.
- Certificate of free sale and
power of attorney must be arranged in order and scanned and saved as one file
only.
Note:
Each attached file must contain the whole document (the document must be not
divided into separate files.
Examples:
Correct:
Power of attorney including 03 pages must be scanned and attached as one file
only.
Wrong:
Divided into 3 attached files.
- In case the owner grants many
powers of attorney to the importer, such powers of attorney must be arranged in
order, scanned and saved as one file, including the owner’s powers of attorney
granted to distributors and importer.
- In case the certificate of free
sale includes many pages and cannot be scanned in one file due to its large
size or cannot be uploaded onto software, the importer may scan the
certification page and the pages including information concerning models of
imported equipment (which has been marked) and save them as one file, and the
importer may be requested to provide the original for comparison as regulated
by laws.
- In case the application must be
carried according to attached annex, the importer shall download form of annex
from the software and fill information according to regulated form, leave
columns without information blank (examples: HS codes, packing specifications
or calculation unit or distributor or country thereof). The completed form
shall be saved in .pdf format and uploaded onto the software. Information other
than that included in regulated form should be not specified.
- Do not download files that are
inconsistent with required contents of the application for import permit or
inconsistent with file contents stated in the software./.
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