Reasons for the Backlog in the Medical Device Licensing Process

According to the regulations of Decree No. 98/2021/ND-CP issued on November 8, 2021 by the Government, the Ministry of Health has conducted evaluations and granted circulation numbers for medical device documentation. However, due to a large number of applications and a lack of human resources directly handling the documentation at the Ministry of Health, the Infrastructure and Medical Device Department has only 7 experts, who, in addition to managing the documentation, also have additional responsibilities. In this situation, the Department is currently proposing the supplement of human resources to process the documentation for Medical Device. 

Additionally, there have been incidents causing increased anxiety among experts during the reading and evaluation of documentation. The Deputy Head of the Infrastructure and Medical Device Department stated that the unit proposes issuing a certificate of registration that can be amended or supplemented up to 5 times from the date of the request for amendment or supplementation from the Ministry of Health. However, statistical data reveals that over 90% of documentation requests for circulation permits require amendments or supplements.

 

All submission, modification, and supplementation procedures for documentation are performed entirely on the electronic portal. This leads to the possibility for businesses to alter the entire content and documentation of their previous circulation registrations, making the evaluation process by experts longer as they have to review the documentation from the beginning. Each documentation needs to be read multiple times, adding to the workload of experts and specialists, especially considering the lack of personnel in the Department.

To address the backlog issue in processing applications for the registration of medical devices, the Office of the Ministry of Health mentioned that the Infrastructure and Medical Device Department is actively applying information technology to streamline procedures and enhance efficiency. The Ministry of Health is also proposing an increase in the evaluation fee for experts to ensure fair compensation, given the high level of responsibility involved.

In recent times, the Ministry of Health has implemented various solutions to expedite the progress of documentation evaluations, including advising the government to issue Decree No. 07/2023/ND-CP to alleviate difficulties for organizations and individuals involved in the import, export, and trade of medical equipment, allowing for an extension of the validity of licenses until December 31, 2024. 

For consultation on document services and the registration process for medical devices, please contact the Hotline: 098.546.1894

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