CFDA Accelerates Effort in Post Market Surveillance — 1st Decree on Adverse Event Reporting

Grace Fu Palma
Sep 4, 2018 · 3 min read

CFDA, part of SAMR (State Administration of Market Regulation), issued Decree №1 for Medical Device Adverse Event Reporting on August 31st. More control, strictness and timely post-market surveillance will be enforced. Furthermore, for the 1sttime, CFDA imposed severe penalties to the violating companies. Penalties include stopping production, suspension of importation and fines.

Legal agent will play a far more significant role with #1 decree than ever before. China Med Device, LLC is 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 CFDA and other key personnel (see our write-up https://chinameddevice.com/major-leadership-demotion-at-cfda-today), 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 (formerly CFDA) announced the Adverse Event Reporting Regulation was in 2011, 7 years ago. The major changes this time include:

  1. Provincial 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”.
  2. Overseas adverse events are required to be reported, and the report must be conducted by local legal agent.
  3. 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!)
  4. Yearly Risk Analysis becomes mandatory.
  5. Penalties, such as stopping production, suspension of importation and fines, are specified for the first time.

Since March 2018, 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). Now CFDA name is being changed to NMPA (National Medical Products Administration).

For CFDA official link of Decree of Medical Device Adverse Event Reporting, please email info@ChinaMedDevice.com.

Keep yourself updated with CFDA News Roundup, click HERE to opt-in. For market access newsletter, click HERE. For CRO services in China, click HERE.

About China Med Device, LLC

China Med Device, LLC (https://chinameddevice.com/) provides turn-key solutions for western medical device/IVD companies to enter China with regulation and commercialization services. Our CFDA regulatory services cover strategy, RA, clinical evaluation, CRO, QA and post market compliance. We are certified legal agent. Our commercial services cover market assessment research, reimbursement, partnership, distribution qualification and management. We have offices in Beijing, Suzhou and Boston. Our management team has 100+ years of combined experience in medical device and IVD and has been involved with 1,000+ CFDA certificates and 250+ companies’ success.


Originally published at chinameddevice.com on September 4, 2018.

Grace Fu Palma

Written by

Grace brings 20+ years of industry experience to the medical device industry. She founded China Med Device in 2011 https://chinameddevice.com/about-us/

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