NMPA (CFDA), part of SAMR (State Administration of Market Regulation), issued Decree No.1 for Medical Device Adverse Event Reporting and Reevaluation on August 31st. More control, strictness and timely post-market surveillance will be enforced. Furthermore, for the 1st time, NMPA (CFDA) imposed severe penalties to the violating companies. Penalties include stopping production, suspension of importation and fines. The Decree is to be effective on January 1st, 2019.
Legal agent will play a far more significant role with #1 decree than ever before. China Med Device, LLC is NMPA (CFDA) certified legal agent. We can help you fulfill the pre and post market legal agent requirements without your needing to setup office in China. For more details on legal agent related regulations, email us at info@ChinaMedDevice.com.
The decree, following the vaccine scandal with the firing of the chief of NMPA (CFDA) and other key personnel (see our write-up HERE), shows Chinese government is going to invest heavily in both financial resources as well as implementing more comprehensive and stricter regulations.
According to the Decree, suspected medical device-related death shall be reported within 7 days; Serious Adverse Events (SAEs) 20 days; Overseas Adverse Events 30 days. Public Health Hazard shall be reported in 12 hours.
The last time the NMPA (CFDA)) announced the Adverse Event Reporting Regulation was in 2011, 7 years ago. The major changes this time include:
- Provincial NMPA (CFDA) offices will take major responsibility for surveillance, instead of National Test Center as in the past. It means more staff and quicker action for “fly-inspection”.
- Overseas adverse events are required to be reported, and the report must be conducted by local legal agent.
- Adverse event records shall be kept 2 years after the expiration date; 5 years if no expiration date provided; Implantable device registration holders shall keep the records permanently. (Foreign manufacturers need to be aware of the data-retaining difference between China and other countries!)
- Yearly Risk Analysis becomes mandatory.
- Penalties, such as stopping production, suspension of importation and fines, are specified for the first time.
Since March 2018, NMPA (CFDA), along with Administration for Industry & Commerce, Administration of Quality Supervision, Inspection and Quarantine, and State Intellectual Property Office, has been reconstructed to State Administration of Market Regulation (SAMR).
For NMPA (CFDA) official link of Decree of Medical Device Adverse Event Reporting and Reevaluation, please email info@ChinaMedDevice.com.
About ChinaMed Device, LLC
ChinaMed Device, LLC (www.ChinaMedDevice.com), a Boston headquartered company, provides regulatory and commercialization turnkey solutions for western medical device, IVD, CDx and combination products to enter China. Our NMPA (NMPA (CFDA)) regulatory services include: RA, regulatory strategy, regulatory submissions, clinical evaluation reports (CER), clinical trials, QA, GMP and post-market compliance. Our commercialization services include: market assessment research, reimbursement, partnership strategies, and distribution qualification. We are a NMPA (NMPA (CFDA)) certified legal agent with offices in Boston and Beijing enabling us to service our clients 24/7.