Import of medical device is a complicated process under Vietnam laws as it applies and impacts on human bodies. Ministry of Health is the Vietnam State Authority governing the import permit of medical device that requires import permit. Lawyers of law firm in Vietnam with experience in medical device should be consulted for the import licensing and sub-licensing process to ensure smooth experience.
1. Introduction about Medical Device
According to Circular No.30/2015/TT-BYT dated Oct 12th 2015 on importing of medical equipment, the term “medical device” is the types of equipment, tool, material and in-vitro diagnosis chemical and software used separately or combined with each other as indicated by the owner to serve people for one or a lot of purposes as follows:
a) Diagnosis, prevention, monitoring, treatment and mitigation of disease or injury compensation;
b) Checking, replacement, modification or surgery support and physiological process;
c) Life support or sustainment;
d) Conception control;
dd) Sterilization of medical equipment (not including chemicals and insecticides and disinfectants for domestic and medical use);
e) Use for medical equipment;
g) Special transport for medical activities.
2. How to import and trade Medical Device in Vietnam
In order to import the Medical Device, the importer has to strictly comply with Vietnam laws, especially setting up the trading company with the function to import and trade Medical Device.
Except those medical devices not yet permitted for use in Vietnam, trading medical device is considered as conditional business that the company must satisfy the following conditions:
a) Medical device must fully comply with the provisions of law;
b) Business entities must be traders defined in the Vietnam Commercial Law;
c) Business establishments must satisfy the requirements on techniques, equipment, facilities, business process and other standards prescribed by law; locations of business establishments must be in line with the planning on development of the network of establishments doing business with goods and/or services subject to conditional business;
d) Managerial and technical staff and employees personally engaged in the sale and purchase of goods, and employees personally engaged in the provision of services must satisfy the requirements on professional qualifications and experience and be physically fit according to the provisions of law;
e) Business traders must have certificates of satisfaction of business conditions in cases where such certificates are required by law to be granted by competent agencies.
3. Permit to import Medical Device
Further, for certain medical device belonging to the list which Vietnam Ministry of Health issues, the importer has to obtain the medical device import permit before importation.
Dossier for new issuance of Medical Device import permit includes:
a) A written request of issuance the permit as prescribed by law.
b) Valid certificate of free sale of types of imported medical devices at the time of submission of dossier.
c) The valid ISO 13485 or ISO 9001 quality systems certification (hereinafter referred to as ISO certification) of manufacturer at the time of dossier submission.
d) The valid Letter of authorization from medical equipment owner to organizations or individuals importing the medical equipment.
e) The technical material describing the types of medical equipment in Vietnamese language.
f) Catalogue describing the functions and technical parameters of types of imported medical equipment.
g) 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.
h) Report on result of import of medical equipment
The dossier will be addressed to the Ministry of Health (Department of Medical Equipment and Health Facilities) and they will review the completeness and validity of dossier within 05 working days. In case the dossier is complete and valid, a meeting of its consultation Council for issuance of medical equipment import permit will be held to review. The import will only be issued if there is no more requirement for modification or addition of import dossier from the Council. The validity of the import permit is until the validity of the letter of authorization and up to 01 year from the date of signature and issuance.