Deepen the Evaluation and Approval Regulations’ Renovation and Encourage Medical Device Innovation

October 9^th 2017, China Council Office published ‘The Suggestion About Deepen Evaluation and Approval Regulations’ Renovation and Encourage Medical Device Innovation ’.

The main contents of the suggestions.

Renovate clinical trial management system.
Speed up the evaluation and approval process for the vital medicine and medical devices.
Encourage medicine innovation and generic drug development.
Strengthen the full life circle management of the medicine and medical devices.
Improve the technical supporting capacity
Strengthen the organization and implementation

Renovate clinical trial management system for the medical devices

Use filing management for the clinical trial institution qualification.
Support medical institutions, medical study institutions, medical colleges and etc. to conduct clinical trials.
Improve the ethics committee rules.
Increase the efficiency of the ethics evaluation.
Improve clinical trial approval process
Accept the oversea clinical trial data
Support trailblazing clinical trials for the vital diseases.
Investigate data fraud

Speed up the evaluation and approval process for the medical devices

Speed up the evaluation and approval process for the vital medicine and medical devices
Support the research and development for the Orphan Diseases medicine and medical devices.

Strengthen the full life circle management of the medicine and medical devices for the medical devices.

Implementation of the marketing authorized holder system.
The implementation of the marketing authorized holder legal responsibility
Establish marketing authorized holder report the adverse reaction and events system.
Improve the medical device reevaluation regulations.

Improve the technical supporting capacity

Improve technical evaluation regulations renovation.
Confidentiality duty of the related staff.
Strengthen the evaluation and supervision capacity.
Implement the whole inspection process responsibility.
Establish the professional inspection teams.

Strengthen the organization and implementation

Strengthen the team organization
Strengthen the cooperation
Properly publicity and explanation.

* If you have any comments or questions, please contact us at md@cirs-group.com.

We have launched a LinkedIn newsletter to keep you up to date on the latest developments across the chemical industry including food and FCMs and personal and home care.