How to Import and Trade Medical Device

   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 firms 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 set 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.

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Trading Conditions on Medical Device in Viet Nam

   Medical device includes device related to human health, therefore, the business of medical device in the conditional business line in accordance with the law of Vietnam. Medical device is defined as kinds of device, tools, materials for implanting activities, reagents and in vitro calibration solutions, software which are used separately or in association with each other according to the instruction of their owners for human use for the purpose of diagnostic, prevention, supervision, treatment and elimination the illness or to making up for pains.

For medical device trading purpose in Vietnam, first of all, the enterprise should classify medical device. Medical device circulated in Vietnam will be classified based on the level of potential risks associated with the technical design and manufacture of such medical device.

Pursuant to Decree No.36/2016/ND-CP on medical device management, medical device shall be classified into the following 2 groups which are divided into 4 types as follows:

– Type 1 comprises Type A medical device which is medical device with low level of risks.

– Type 2 comprises Type B, C and D medical device, where

+ Type B medical device is medical device with lower average level of risks;

+ Type C medical device is medical device with upper average level of risks;

+ Type D medical device is medical device with high level of risks.

In case medical device can be classified into two or more levels of risk, the classification by the highest risk level of such medical device shall be applied. The classification of medical device must be conducted by qualified organizations as provided by law. In addition, the law of Vietnam recognizes the results of classification of medical device made by competent regulatory body in other countries such as Korea, Japan, … on the basis of international treaties or international arrangements to which Vietnam is a party or of a country which adopts a medical device classification system similar to that adopted by Vietnam.

After classifying medical device, the enterprise shall declare applicable standards for Type A medical device or issue certificate of free-sale registration for Type B, C, D medical device. This procedure makes sure that medical device which the enterprise has trading requirements, is allowed to be distributed in Vietnam.

Finally, with the exception of medical device of type A, in order to directly sell medical device to consumers, the enterprise needs to ensure the staffing requirements as well as the material facility requirements in accordance with the law, for instance:

Trading premise must have technically qualified staffs to perform the installation and use instructions suitable to the medical device which the establishment buys and sells, including at least one qualified technical staff specialized in technical or medical or pharmaceutical medical or technical colleges of medical device or higher or college or higher degree, whose specialized training is appropriate to the type of medical device that the establishment purchase.

Trading premise needs to prepare the warehouse which has area in accordance with the type and the quantity of the medical device to be stored. The warehouse should be airy, dry, clean, separated from sources of pollution and satisfied with other storing requirement device according to its manual. In addition, trading premise shall have suitable transportation vehicles for delivering of medical devices from trading premise to received place. In case there are no storage facilities or transport means, a contract with an establishment satisfying requirements for storage facilities and transport of medical device shall be concluded

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