Suggested Reading
Rules for Medical Device Nomenclature( April 1, 2016) Provisions for the Supervision and Administration of Drug Manufacturing(July 1, 2020) Provisions for Drug Registration(July 1, 2020) Provisions for Adverse Drug Reaction Reporting and Monitoring(May 4, 2011) Regulations for the Administration of Overseas Inspection of Pharmaceutical & Medical Devices (December 26, 2018) Provisions for Instructions and Labels of Medical Devices(October 1, 2014) Guidelines for the Use of Real-World Data in Clinical Evaluation of Medical Devices-Trial(Nov 24, 2020) Guidelines for Review of Medical Device Usability Engineering Registrations (March 27, 2024) Application Note on Guideline for theReview of Medical Device Usability Engineering Registrations (October 8, 2024) Guidelines for Medical Device Usability Engineering Registration Review (March 19, 2024)