New Requirements For Medical Device And IVD Registration Application Dossiers
2021-11-03
More and more new guidelines are published according to the Regulations on Supervision and Administration of Medical devices (Order 739), the Administrative Measures for Registration and Filing of Medical Devices (Order 47) and the Administrative Measures for Registration and Filing of IVD (Order 48). Since Jan 1, 2022, new requirements for medical device/IVD registration application dossiers will be effective.
Key notes for new requirements
For innovative medical devices, it is acceptable to have no home country approval when applying China registration.
Legal agent on the certificate for overseas manufacturers shall be the enterprise with legal person based in China.
If the product structure features, intended use, use method etc. are not consistent with the applicable scope of mandatory standards, the applicant shall submit the statement to indicate such mandatory standards are not applicable, and provide the proof after validating.
More detailed requirements for software description documents and cybersecurity documents.
More detailed requirement for clinical trial dossiers, such as raw data base for clinical trial
Adding requirement on QMS dossiers
Etc.
To understand more requirements for China medical device and IVD registration, please attend our upcoming webinar: Revisiting Order 739 – Significant Updates for Medical Device Registration in China: Dossier Prep, Self-Testing, CER, and PMS. Or email us: info@inspirativemed.com
