Relevant units,
The main task of Good Regulatory Review Practices (GRRP) working group of International Medical Device Regulators Forum (IMDRF) is to promote the international coordination and unification of the pre-market review of medical devices by formulating the technical and management documents for pre-market review of medical devices. As the outcome document recently released by the GRRP working group, the Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices clarifies the basic principles of safety and effectiveness of medical devices, provides a strong basis for the evaluation, and also clarifies the focus for R&D and production of enterprise.
To further standardize the requirements for examination and approval of medical devices, implement regulatory science program, and improve quality and efficiency of technical evaluation work to medical device, based on the above document of GRRP working group, we, the Center for Medical Device Evaluation of National Medical Products Administration, have organized and formulated the Essential Principles of Safety and Performance of Medical Devices (Draft for Comments), which is now open for comments. We hope that experts, scholars, manufacturing enterprisers and relevant practitioners in the relevant fields can give us valuable comments and suggestions.
If there is any comment or suggestion, please download and fill in the feedback form, and send it back to us by email before January 31, 2020.
Center for Medical Device Evaluation of National Medical Products Administration
December 20. 2019
For original text and document, please refer to original Chinese website
The main task of Good Regulatory Review Practices (GRRP) working group of International Medical Device Regulators Forum (IMDRF) is to promote the international coordination and unification of the pre-market review of medical devices by formulating the technical and management documents for pre-market review of medical devices. As the outcome document recently released by the GRRP working group, the Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices clarifies the basic principles of safety and effectiveness of medical devices, provides a strong basis for the evaluation, and also clarifies the focus for R&D and production of enterprise.
To further standardize the requirements for examination and approval of medical devices, implement regulatory science program, and improve quality and efficiency of technical evaluation work to medical device, based on the above document of GRRP working group, we, the Center for Medical Device Evaluation of National Medical Products Administration, have organized and formulated the Essential Principles of Safety and Performance of Medical Devices (Draft for Comments), which is now open for comments. We hope that experts, scholars, manufacturing enterprisers and relevant practitioners in the relevant fields can give us valuable comments and suggestions.
If there is any comment or suggestion, please download and fill in the feedback form, and send it back to us by email before January 31, 2020.
Center for Medical Device Evaluation of National Medical Products Administration
December 20. 2019
For original text and document, please refer to original Chinese website