2021 NMPA CFDA Key Updates and Look Ahead on 2022

China NMPA introduced a series of significant changes in medical device, IVD, companion diagnostic and combination products regulations in 2011. . With the implementation of decree Order 739, “Regulation on the Supervision and Administration of Medical Devices”, tens of new regulations and major updates in the forms of policies, guidelines, standards, and announcements were released in 2021. These updates and changes have impacted the complete product life cycle from new submissions, renewals to post market surveillance.

One giant leap from China medical device regulators—the NMPA began to recognize self-test report from manufacturers, with guidelines on the requirements and qualifications for self-test reports. New China CGP has been published adjusting the overall framework. Several clinical guidelines in CER, establishing equivalence, determining when to do clinical trial etc have been introduced. GMP as a new section requirement is added to the e-Filing catalogue.

With the sweeping changes, how can manufacturers or inventors be proactively prepared to shorten their time to market for new submissions, allow enough lead time for renewal as well as to know when to file for modifications to avoid penalties. Above all, how to stay compliant after your approval to meet China post market compliance as well hospital reimbursement code requirements.

Key updates include:
* Under Order 739: New law, regulation, policy, standards & guidelines
* New Perspective on Clinical Evaluation Pathways: clinical evaluation decision tree, overseas clinical data acceptance, clinical trial or not, piloted real-world data
* IVD & Combination Device
* Great Bay Area & Hainan Special Policy for NMPA Un-approved devices use in China
* PMS/QMS(NHSA code, AE, Recall & Overseas Inspection)