As a member of IMDRF (International Medical Device Regulators Forum), China is actively leading and participating in the formulation of relevant regulatory documents for international medical devices. Since 2019, NMPA has initiated to amend current China GCP (Good Clinical Practice), and in this May, NMPA collected public opinions on the draft of new China GCP.
Major amendments in GCP are listed as below:
IVD clinical trial regulated by GCP as medical device
Clarify the responsibilities of each party involved in clinical trial
Sponsor is a major role in clinical trial
Risk management into clinical trial
Sponsor’s QMS shall cover the whole process of clinical trial
Adjust the safety information reporting process (SAE reporting)
Simplify and optimize some requirement
Delete the requirement of Medical device clinical trial shall be conducted in two and above clinical trial institutions, solving the issue of some medical devices difficult and not necessary to conduct clinical trial in two sites.
Delete the requirement on test report with 1-year validity (one important dossier for IRB/EC application), beneficial to clinical trial.
Reflect the requirement of latest international regulatory system (IMDRF MDCE WG/N57 FINAL:2019)
Introducing the concept of conducting multi-region clinical trial in different countries or regions
Beneficial to global innovative device conducting medical device clinical trial in China in parallel
Although new amendments in GCP are conductive to clinical trial in China, the requirements of clinical trial following GCP have always been enhanced. The least burdensome clinical approach is the most critical issue for China entry plan related to cost and time.
Brady knows the least burdensome clinical approach whether you are marking clinical strategic plans, launching pre-market or post-market clinical trials, writing a CER to meet country-specific requirements, or collecting real-world data to support your submission. Reach out to BradyKnows for the least burdensome clinical approach via info@inspirativemed.com
