China Register Category

 

Top Articles

  • The procedure for Import Drug SFDA Registration
  • CFDA Releases Plan to Improve Medical Device Adverse Event Monitoring
  • Our Services for IDL(Import Drug Licence) of SFDA
  • China Supervision and Inspection of Drugs
  • Application and approval procedure for drugs(2)
  • China Launches Review of Medical Device Industry
  • The drugs which can be exempted from clinical trials in China
  • CFDA Reduces Application Requirements for Medical Device License Amendment and Renewal Processes
  • CFDA Issues Guide for Routine Inspections of Medical Device Manufacturers
  • CFDA Issues Proposed Regulations on Medical Devices
  • China Hygiene Supervision and Inspection of Food
  • Application and approval procedure for clinical trials
  • Our Services for IPEL (Import pharmaceutical excipient Licence)
  • China Import Control on GM Agricultural Bioproducts
  • Requisite documents of Drugs SFDA Registration
  •  

    Latest Articles

  • China Hygiene Supervision and Inspection of Food
  • China Supervision and Inspection of Drugs
  • China Supervision and Inspection of Mechanical and Electrical Products Regulations.
  • China Import Control on GM Agricultural Bioproducts
  • China Customs Clearance for Goods Subject to Entry-exit Inspection and Quarantine
  • What is AQSIQ of China?
  • China Issues Special Procedures for Innovative Medical Devices
  • CFDA Issues Guide for Routine Inspections of Medical Device Manufacturers
  • CFDA Releases Draft Good Supply Practices for Medical Devices
  • CFDA Reduces Application Requirements for Medical Device License Amendment and Renewal Processes
  • CFDA Releases Plan to Improve Medical Device Adverse Event Monitoring
  • China Launches Review of Medical Device Industry
  • China Reorganizes the State Food and Drug Administration and Appoints a New Commissioner
  • China FDA Seeks to Improve Medical Device Evaluation at the Provincial and Municipal Government Levels
  • CFDA Publishes Draft Rule on Administrative Procedure for Public Comment
  •  

     

     

     

     
         Home >> China Regulations News
     

      CFDA Issues Proposed Regulations on Medical Devices

    ADD DATE:2014-4-13 HITS:8

    On March 20, 2013, the China Food and Drug Administration (CFDA) released for public comment two proposed regulations on medical devices. The comment period for the proposed regulations ended on March 31, 2013. The first proposed regulation ! titled Special Review and Approval Process for Innovative Medical Devices (Interim) (draft) ! provides for special review and approval for qualified devices for which the applicant holds intellectual property rights. The regulation is aimed at increasing innovation in the Chinese medical device industry. To qualify for the special process, an applicant must be a Chinese legal entity and have either (i) led the technological innovation to develop the device and been granted an innovation patent, or (ii) lawfully obtained the rights to use the invention patent in China. The applicant must also agree to manufacture the device in China. See our full client alert for a list of additional requirements and a description of the special review and approval process. The second proposed regulation! titled Regulation for Simplification of Application Materials Required for Medical Device License Re-registration (Interim) (draft) ! simplifies the application materials required in the license re-registration process. If there have been no material changes in safety or efficacy, the applicant no longer needs to provide the operation manual, product standards, and test reports. If there have been any changes to the model specification, manufacturing site address, product standards, functional structure or components, or indications for use, the applicant needs only provide documents related to that change.
     
    Similar topics:


     

       >> Contact a RJS expert for more information >>

     
     
       
     

    | +86-400-657-8191 | Guangdong:+86-755-25831330 | Beijing:+86-10-51663836 | Shanghai:+86-21-31255165  |

    RJS MedTech Inc.  ©  Copyright 2000-2015 All Rights Reserved