Vietnam Import requirement of medical equipment

Vietnam Import requirement of medical equipment

1. General

1.1. In order to determine the banned product or not, please check the annex of the Government’s Decree No. 69/2018 / ND-CP. If the product is not in list of prohibited imports and exports, it shall import into Vietnam.

1.2 Medical equipment import Permit

Medical equipment is under management of Ministry of Health.

If the product is under list of appendix 1- Circular 30/2015/TT-BYT. It need to make medical equipment import Permit.
If the is not under list of appendix 1- Circular 30/2015/TT-BYT. The product shall be imported as normal procedures.

1.3 Other customs dossier and procedure

According to clause 5 , 6 , 7 of article 1 of Circular No. 39/2018/TT-BTC and article no. 18 of Circular No. 38/2015/TT-BTC specifies on Dossiers of import procedures.

http://vietnamthings.com/2019/03/12/latest-vietnam-customs-document-during-customs-procedure/

2. How to make Medical equipment import Permit

According to article 6 of Circular 30/2015/TT-BYT, it specifies Dossier for new issue of medical equipment import Permit:
-The written request for new issue of medical equipment import Permit (Form No.01)
– Valid Certificate of free sale
– ISO Certification of the manufacturer at the time of dossier submission.
– The valid Letter of authorization Form specified in Annex III issued with this Circular
– The technical material (in Vietnamese language under the Form No. IV)
– Catalogue describing the functions and technical parameters
– The clinical assessment material and manual of owner or manufacturer for the medical equipment specified in section 49 of Annex I issued with this Circular.
‘* NOTE:
According to article 10 of Circular 30/2015/TT-BYT: Requirements for papers in dossier for medical equipment import Permit:
– Certificate of free sale in the import dossier:
+ Original or certified copy or copy with seal of the organization requesting the import or copy with signature of individual requesting the import. In case of submission of copy of Certificate of free sale with the seal of organization requesting the import or signature of individual requesting the import, there must be an original presented for comparison.

+ Certificate of free sale is issued by the foreign body: If the language used in the CFS is not English or Vietnamese, it must be translated into Vietnamese; – ;- Consularly legalized under the provisions of Decree No. 111/2011/ND-CP except that the Certificate of free sale is issued by the competent body of the countries signing the Agreement on mutual legal assistance with Vietnam.
– ISO certification in the import dossier: Original or certified copy or copy with seal of the organization requesting the import or the copy with signature of individual requesting the import. In case of submission of copy with the seal of organization requesting the import or signature of individual requesting the import, there must be the original presented for comparison.
– Letter of authorization:
+ Original or certified copy or copy with seal of the organization requesting the import or the copy with signature of individual requesting the import.
+ If Letter of authorization issued by the foreign body:If the language used in the letter of authorization is not English or Vietnamese, it must be translated into Vietnamese;- Consularly legalized under the provisions of Decree No. 111/2011/ND-CP except that the Certificate of free sale is issued by the competent body of the countries signing the Agreement on mutual legal assistance with Vietnam.
– Catalogue describing the functions and technical parameters: Original or certified copy or copy with seal of the organization requesting the import or the copy with signature of individual requesting the import. In case of submission of copy with the seal of organization requesting the import or signature of individual requesting the import, there must be the original presented for comparison.

application for new issue of medical equipment import permit

2.1 How to make Application for new free-sale registration number
‘According to Article 26 of 36/2016/NĐ-CP: Application for new free-sale registration number

2.1.1. An application for the registration number of free sale of medical equipment for which there is no applicable National technical regulation:
a) A written application form for a new free-sale registration number using the form No. 04 provided in Annex I enclosed with this Decree;
b) A classification table using the form in Annex V enclosed with this Decree;
c) The certificate of conformity with quality control standards which is effective at the time of application, unless the medical equipment has been issued with the Certificate of Free sale by the competent body of any of the following countries and organizations: EU member countries, Japan, Canada, Therapeutic Goods Administration (TGA) of Australia, Food and Drug Administration (FDA) of America;
d) The power of attorney by the owner of the medical equipment for the establishment conducting the free-sale registration using the form in Annex VI enclosed with this Decree which is effective by the time of application, except for cases specified in point a clause 1 Article 21 of this Decree;
dd) The certificate of eligibility to provide warranty issued by the owner of the medical equipment using the form provided in Annex II enclosed with this Decree, excluding disposable medical equipment prescribed by its owner;
e) The Certificate of free sale which is effective at the time of application, applicable to imported medical equipment;
g) Vietnamese documents that give brief description of medical equipment using the form No. 01 in Annex VIII enclosed with this Decree;
h) A catalogue describing functions and specifications of medical equipment; technical information on reagents, calibration solutions, in vitro control materials using the form No. 02 provided in Annex VIII enclosed with this Decree;
i) Written instruction for the medical equipment;
k) Regarding type C or D medical equipment which is used by putting into human body: the summary of clinically testing data using the form in Annex IX enclosed with this Decree together with the clinically testing reseach results are required, unless:
– Medical equipment is manufactured or processed in Vietnam solely for export and the importing country does not request clinical testing;
– Such medical equipment has been freely sold and obtained the Certificate of Free sale by the competent body of any of the following countries and organizations: EU member countries, Japan, Canada, TGA of Australia, FDA of America;
– Other cases specified by the Minister of Health.
l) Type C or D medical equipment for in vitro diagnosis must have the certificate of inspection as prescribed by the Minister of Health, unless the medical equipment has been issued with the Certificate of Free sale by the competent body of any of the following countries and organizations: EU member countries, Japan, canada, TGA of Australia, FDA of America;
m) The label of the medical equipment which is intended to be used when such medical equipment is freely sold in Vietnam.

2.1.2 Regarding the application for the registration number of free sale of medical equipment with applicable National technical regulations:

a) A written application form for a new free-sale registration number using the form No. 04 provided in Annex I enclosed with this Decree;
b) The certificate of conformity;
c) Papers specified in points b, c, d, dd, e, g, h, i and m clause 1 of this Article.

the application for the registration number of free sale of medical equipment

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