Following the 13th Five Year Plan (2016-2020), CFDA has conducted overseas inspection covering all imported high-risk medical devices. Since November 2017 when CFDA began to publish overseas inspection results, 24 foreign manufacturers have been found with issues. Inspected facilities are located in US, UK, Germany, Japan, South Korea, Switzerland, France and Australia
For the draft guideline on Medical Device Overseas Inspection, click HERE
For the webinar on overseas inspection, click HERE
Observations were categorized by active and non-active medical devices and IVD:
7 active device manufacturers got caught with 40 observations. Agfa HealthCare (Germany) and St. Jude Medical (US) and Terumo (Japan) were included.
12 non-active device manufacturers got caught with 58 observations. Covidien (US) and Zimmer (Switzerland) were included; Biocomposites (UK) was suspended for importing.
5 IVD manufacturers got caught with 16 observations. Beckman Coulter (US) and DiaMed GmbH (Switzerland) were included; Leica Biosystems (UK) was suspended for importing.
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, premarket submission, clinical evaluation, CRO, QA and post market compliance. We are experienced in handling innovation approvals and priority reviews. 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.