CFDA Medical Device Certification China
For the CFDA Medical Device Certification the China Food and Drug Administration (CFDA) recently released the 2016 Annual Report for National Medical Device Adverse Event Monitoring, which includes the general situation of medical device adverse event reporting, the statistical analysis of medical device adverse events, the intensive monitoring of medical device adverse event，the quality assessment of medical device adverse event reporting, and the release of medical device vigilance newsletter in 2016. The report reflects comprehensively the performance of China’s medical device adverse event monitoring in 2016.
CFDA issues Provisions for Medical Device Standards
To implement the newly revised Regulations for the Supervision and Administration of Medical Devices, China Food and Drug Administration (CFDA) organized the revision of the Measures for Medical Device Standards (interim), and formulated the Provisions for Medical Device Standards. The Provisions for Medical Device Standards was adopted at the executive meeting of China Food and Drug Administration on February 21, 2017, and shall be effective as of July 1, 2017.
The promulgation of the Provisions for Medical Device Standards will play a positive role in guiding China’s standardized management of medical devices, regulating the formulation and revision of standards, promoting the implementation and improvement of standards, and improving the quality of medical devices
CFDA issues Amendment to the Provisions for In-vitro Diagnostic Reagent Registration
China Food and Drug Administration (CFDA) issued the Amendment to the Provisions for In-vitro Diagnostic Reagent Registration (CFDA Order No. 30) on January 25, 2017, which shall come into effect as of the date of promulgation.
YY/T0287-2017 “Medical devices–Quality management systems–Requirements for regulatory purposes” officially released
On January 19, 2017, China Food and Drug Administration issued YY/T0287-2017/ISO13485:2016 “Medical devices–Quality management systems–Requirements for regulatory purposes”, which will come into force as of May 1, 2017.
YY/T0287-2017 idt ISO13485:2016 further stresses regulation, emphasizes the importance and necessity of implementing regulatory requirements, improves the compatibility of regulations and the standard; defines that the quality management system standard is applicable to medical device organizations at all stages of the full life cycle industrial chain, further guarantees the safety and effectiveness of medical devices at all stages of the full life cycle; intensifies the new requirements based on risk analysis and risk management; advances new requirements to medical device supply chain and procurement; and adds new requirements on the post-market surveillance and improvement of medical devices.
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