Backlog remains in new decree on medical devices

Qadeer Raza - Chairman, Medical Device Diagnostics Sector Committee European Chamber of Commerce in Vietnam

Of particular concern, Decree No.07/2023/ND-CP amending and supplementing a number of articles of Decree No.98/2021/ND-CP dated November 2021 on medical devices management and import licences issued from January 2018 to December 31, 2021 may continue to be used until the end of 2024.

In addition, the marketing authorisation number for in-vitro diagnostic biological products issued from January 2014 to December 31, 2019 may continue to be used until the end of 2024.

The new decree helps us to solve problems in importing medical devices due to expired licences. We hope that the supply of devices will be resumed smoothly in the future.

In addition, Decree 07 only stipulates the declaration of prices for related devices when there is an abnormal price fluctuation affecting the supply of, the buyer’s ability to pay, and the Health Insurance Fund’s ability to pay. The list of devices requiring price declaration will be issued by the minister of health.

The content, form, order and procedures for declaring the price of such devices shall comply with the provisions of the law on prices or on the e-portal of the Ministry of Health (MoH).

This helps to reduce the burden for businesses and the medical industry in declaring prices, as previously it had to make more than 200,000 types, each with different configurations and models. It also helps to ensure timely updates of price declaration information.

It also speeds up the marketing authorisation granting process for class C and D medical devices according to Decree 98. Decree 07 has extended the validity of the import licence and marketing authorisation to the end of 2024. Thus, the MoH has more time to appraise and grant marketing authorisation numbers for devices class C and D’s dossiers submitted according to Decree 98.

According to our records, the approval rate for granting marketing authorisation numbers for devices class C and D is still very low, so we recommend that the MoH urgently speed up the appraisal and granting process.

The decree also separates the mechanism for threading and granting the marketing authorisation numbers for new class C and D medical devices, new techniques, new systems, and newly invented technologies.

However, there is a large backlog of related devices of class C and D dossiers. Hence, new medical equipment, systems, and technologies are waiting for market authorisation, with no idea of knowing how long they will have to wait.

Currently, Decree 98 and Decree 07 do not have a separate mechanism for threading and granting the marketing authorisation numbers for new class C and D medical devices, which leads to limited or delayed launching of new technologies and new techniques for medical examination and treatment.

There are some specific regulations and guidelines for post-audit work. We have relieved to learn about the government and the MoH’s policy of transitioning from pre-audit to post-audit. Accordingly, enterprises are responsible for information on medical devices and authorities are responsible for organising inspections and examinations.

We hope that the Vietnamese government and the MoH will have specific regulations and guidelines for post-audit activities to help enterprises understand, properly implement, and cooperate with the authorities.

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