Lots of regulations on management of medical equipment are supplemented

This is the noticeable contents of the Decree No. 169/2018/ND-CP amending and supplementing the Decree No. 36/2016/ND-CP on management of medical equipment.

The Decree provides supplements to a lot of regulations on management of medical equipment as follows:

- All certificates of completion of training in classification of medical equipment which were granted before December 31, 2018 are valid for 3 years since the signature date;

- Holders of marketing authorization numbers of marketing authorization certificates must review results of classification of medical equipment and report to the Ministry of Health prior to July 1, 2019;

- ASEAN Common Submission Dossier Template takes effect from July 1, 2020.

In addition, the Decree adds regulations that stipulate the quick issue of new marketing authorization numbers for medical equipment in the following cases:

- Medical equipment has been granted marketing authorization in at least 02 countries including: Japan, Canada, Australia, United States and other EU states;

- Medical equipment must be granted marketing authorization ahead of December 31, 2018 and must meet the following requirements:

+ Medical equipment has been circulated for at least 03 years within the validity period of 05 years till the date of submission;

+ There is none of warnings about quality and safety of such medical equipment.

For more details, see the Decree No. 169/2018/ND-CP in force from December 31, 2018.

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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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Please click to learn more about Medical Device Law Firm in Vietnam or contact our lawyers in Vietnam for advice via email ant@antlawyers.vn or call our office at +84 28 730 86 529.

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