2022/10/17

The new policy set by TFDA-Medical device management act

Due to the diversified development and types of medical device in recent years, it is gradually different from the drug management model. And the risk level of medical device is determined according to the classification and grading management.

Therefore, TFDA has separated the regulations on medical devices from the "Pharmaceutical Affairs Act" and enacted an independent legislation into the "Medical Device Act", which included “Medical Device Quality Management System”, “Regulation of Medical Device Good Distribution Practice” , “Regulations on Good Clinical Practice for Medical Devices”, “Regulations for Management of Medical Device Safety Surveillance” and other relevant standards and regulations. Medical Device Act taken effect on May 1, 2021.

There are 85 articles in the Act, mainly for the risk management and classification of medical device to formulate content. The key points are as follows:

The design and repair of medical devices are included in this act of medical device management.
Enhance the management of medical devices, establish and maintain regulations about manufacture, sale, direct supply of products, quality management system and Good Distribution Practice (GDP) of medical devices.
For specific medical devices announced by the central competent authority, the registration adopts the electronic online system, and the registration effect will be continued through the annual declaration.
The validity period of medical device advertisements is changed to 3 years; the census of medical device manufacturers is changed to at least every 2 years.
To protect the rights of subjects in clinical trial, any serious adverse events should be reported to authority. If authority deems the clinical trial may cause harm to the health of human body, it may suspend or terminate the trial. The trial that don’t involve significant risks as announced don’t required the approval from authority.
To ensure the quality and safety of commercially available medical device, medical device firms shall establish safety plan and corrective and preventive action and prepare and submit safety monitoring reports to the authority periodically.

Medical Device Act summarization：

Medical Devices Act	Regulations for Medical Device Recalls
Enforcement Rules of Medical Devices Act	Specific medical device project approval manufacturing and import methods (no English version)
Regulations Governing the Classification of Medical Devices	Regulations on Good Clinical Practice for Medical Devices
Regulations for Management of Medical Devices Technicians	Regulations for Management of Medical Device Safety Surveillance
Regulations of Medical Device Tracking Management	Regulations for Reporting Serious Adverse Events of Medical Devices
Standard for medical device manufacturers setting(no English version)	Regulations Governing Border Inspection and Examination of Imported Medical Devices
Medical Device Quality Management System Regulation	Regulations for Medical Device Recalls
Regulations Governing the Inspection of the Medical Device Quality Management System and the Issuance of the Manufacturing license	Administrative fee standards for medical device (no English version)
Regulations Governing Contract Manufacturing of Medical Devices	Regulations Governing Designation or Commission of Medical Devices Test
Regulations of Medical Device Good Distribution Practice	Regulations Governing Commission of Medical Devices Management and Accreditation of Commissioned Institution
Regulations for the Inspection of the Good Distribution Practice for Medical Devices and Licensing of Distribution License	Regulations Governing Incentive Rewards for Research and Development of Innovative Medical Devices Technology

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