Under CFDA Guideline Nos 14 and 218 issued in 2015, China targets sterile devices, implant and IVDs for overseas onsite inspection for registration and issuing manufacturing permit, including change order and renewal, and other necessary inspections. Fly inspection applies to drug and devices in the whole process of R&D, production, sales and services, and is typically triggered by situations with heightened safety risks. Foreign manufacturers are encouraged to incorporate CFDA GMP regulations and standards into their QMS system.
Email us for the report we prepared for you about CFDA’s on-site inspection policy and practice. Contact us to know more about this topic and how it may impact your device manufacturing for China market,