The MFDS allows the manufacturing and import of existing products for a period of 6 months following the approval of medical device changes

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Medical Devices


The MFDS has prepared a proposed amendment to regulations regarding medical device permits, notifications, and evaluations, and it was announced for administrative notice on November 1st. Public opinions will be accepted until November 22nd.


The key aspects of this revision include allowing the manufacturing and import of the previous product for a period of 6 months after a change permit for certain modification items, providing criteria for technical documentation review when applying for medical device modification permits, and expanding the scope of accepted data concerning biological safety.


● Manufacturing and import of pre-existing products allowed for 6 months after the change permit.
Previously, medical device manufacturers and importers were not allowed to manufacture or import medical devices from the 'pre-change permit' period once a change permit had been granted. However, going forward, in cases where the medical device itself remains unchanged, such as model name changes, changes in the period of use, or changes in sterilization methods that do not pertain to product defects, safety information, or actions taken by domestic or foreign government agencies, they will be allowed to manufacture or import products from the 'pre-change permit' period for a period of 6 months after receiving a change permit.

● Providing criteria for technical documentation review when applying for medical device modification permits.
Previously, specific criteria for assessing changes that affect the safety and efficacy of medical devices were not provided. However, moving forward, criteria for each category, such as design, structure, raw materials, manufacturing methods, intended use, and performance, will be established and provided.

● Expanding the scope of accepted data concerning biological safety.
The recognition scope of 'biological safety-related data' that must be submitted to the MFDS for medical device technical documentation review is expanded, allowing the submission of biological evaluation reports based on the latest international standard (ISO 10993-1:2018).

The MFDS expects that this revision will help medical device manufacturers and importers to supply safe and effective medical devices rapidly and reliably.



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