Four Important Measures to Promote the Reform of Medical Device Registration Management in 2017

Recent years, CFDA has implemented so many medical device regulations to manage the medical device registration. In 2017, CFDA implement four important measures to promote the reform of medical device registration managements.

Comprehensively Improve the Medical Device Registration Management

Implemented the “Priority Approval Procedure for Medical Device”
Implemented the “Special Approval Procedure for Innovative Medical Device” and encouraged the R&D activities of innovative medical devices.
Improved medical device classification management reform and established a medical device classification technology committee
Issued the “Catalogue of Medical Device Classification” and the related provisions
Implemented the “Provisions for Medical Device Standards Management” and kept the China standards with the international standards
Supervision and administration of medical device clinical trials
Enhanced the capacity of technical evaluation institution
Enhanced the capacity of provincial technical evaluation institution
Reified and optimized the medical device registration technical review and administrative approval

Strengthen the Data Authenticity Inspection

CFDA will strengthen the medical device clinical trial supervision and administration
Drafted the clinical trial inspection points and rules under medical device GCP
Enhanced the supervision and inspection of the clinical trial process
Draft the “Supervision and Administration Measures on Medical Device Clinical Trials”
Established the medical device clinical trial institution filing management system
Increased the number and scope of clinical trial institution
Established the team of GCP inspector

Release the New 'Catalogue of Medical Device Classification'

Drafted the revised “Catalogue of Medical Device Classification”, submit it to WTO/TBT and release it for comments
The CFDA Medical Device Classification Committee has reviewed the new catalogue and it will be issued soon
CFDA will establish the Classification Database and the dynamic mechanism on medical device category modification

Implement the 100 Standards Plan

April 17^th 2017, CFDA released the “Administrative Measures of Medical Device Standards”
CFDA will explain the standards regulations exactly and give more training for medical device companies
Enhanced the management of the medical device standard compilation and modification process.
CFDA will release the medical device standards for public. The medical device regulations will be modified frequently. It may affect the medical device registration process. The medical device companies shall follow up the regulatory updates and adjust the registration strategy in time.

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