Foreign device manufacturers are encouraged to move production site into China
On March 5th, NMPA issued an asking for comment version of Transfer Manufacturing of Approved Imported Device to be in China. This draft proposes that the registrant of imported medical devices, through its foreign-controlled investment enterprise established in China, can also apply for domestic medical devices certificate. Once approve, they can produce locally the same products approved as imported ones.
Management measures on the sampling inspection of medical devices
NMPA revised the measures on sampling inspection to strengthen the medical devices post market management and surveillance. It includes 7 chapters from general provisions, plans, inspection sampling, inspection management and report, re-inspection, supervision management and supplementary provisions. The manufacturer and the sampled producer shall recall, investigate the causes and take risk control measures in time after being informed of sample inconformity. the Inspection institution shall immediately notify the authority to investigate in case of serious quality and safety risks identified and publicize the results.
NMPA published 2019 China Medical Device Registration White book
An overview and official guidance to look back to year 2019 on device registration work. This report details the key regulation work progress and regulation updates, registration application and approval with statistics, and innovative devices summary.
Essential Principles of Safety and Performances for Medical Devices and IVDs
Chines 2014 version of Essential Principles of Safety and Performances is based on GHTF 2012 version. This new version fully converts IMDRF 2018 revision. Some major changes are the focus on products safety and performance through the whole life cycle, the ongoing update of risk management and extended applied scope, new requirements for clinical evaluation and innovative technology. It is also a signal that China will be further integrate and follow up with international standards and practices.
Continuous efforts to approve the IVD test kits for coronavirus
In addition to Registration Technical Review Key Points for Novel Coronavirus (Covid-19) Antigen/Antibody Detection Reagent, and Registration Guidance on Coronavirus Nucleic Acid Detection Reagent, NMPA continuously encourage the fast track approval to launch new Covid-19 test kits. Up to March. 19 in total Coronavirus diagnostics kits have been approved under Emergency Approvals, including 11 employing the nucleic acid method and 8 utilizing antibodies method.
Regulations on the Management of Experimental Clinical Trials of medical devices (Trial)
This applies to the situation that patients with life-threatening diseases without effective treatment. Medical devices that have not been approved for sale in China may be used in clinical trials in the 3A gradings health institutions. The conditions are the patients, not qualified to be enrolled in normal pre-market clinical trial, may benefit from the extended use treatment, and risks from using unapproved device outweigh their own diseases. The trial shall also be free to the subjects and follow up Chinese GCP.
Should you have more questions regarding China regulations, please feel free to contact Qserve at firstname.lastname@example.org.