Proposed partial amendments to the Regulation on medical device approval/report/review, etc.; (18 page(s), in Korean)
The proposed amendments to the Regulation on medical device approval/report/review, etc. is as follows:
1) Recognition of real-world evidence when reviewing clinical trial data
- For clinical trial data, human test data, theses and papers (class of medical device 1 and 2) must be submitted. It is to prepare the basis for recognition of real-world evidence when reviewing clinical trial data depending on the characteristics of medical devices such as rare and urgently needed medical devices.
2) Introducing a custom classification procedure for newly developed medical devices such as digital health devices
- To support rapid commercialization of newly developed medical devices by establishing a procedure for introducing custom classification procedure for newly developed medical devices such as digital health devices
3) Preparation of grounds for multiple purposes description of combination medical devices according to its characteristics
- In the case of combination medical devices, a single purpose of use is described when applying for permission, but in order to operate a flexible screening and rational system that reflects the characteristics of various combination medical devices, we are trying to prepare a basis for listing more than one purpose of use according to the characteristics.
4) Easing double inspection when distributing used special medical equipment
- For special medical equipment of which safety and performance are regularly checked through quality control, the certificate of inspection is exempted when distributing used products.
5) Expansion of expedited review including medical devices subject to production/import suspension reporting
- Subject of expedited review is expanded to include medical devices subject to production/import suspension reporting and public health crisis response medical devices to promote prompt response and public health in the event of supply/demand occurrences such as production/import suspension
6) Increase test report accreditation body for biosafety data
- To expand citizens' choice by increasing the number of laboratory audit institutions designated by the Minister of Food and Drug Safety for biosafety data
7) Minor change improvement
- Revise usage methods and precautions according to re-evaluation results, change of appearance of components, etc.