CHINA: Innovative Development Plan of Introducing Drug and Medical devices in Guangdong, Hong Kong, Macao and the Greater Bay Area
- 2021-01-19 02:48:31
The Medical Device Division (MDD) Hongkong will continue the trial scheme to simplified application and approval process of Class II/III/IV general medical device listing applications with established support on proven safety and performance.
MoreThe Medical Device Division will continue the trial to study the feasibility for Local Responsible Persons (LRP) to prove their medical device conform the “Essential Principles of Safety and Performance of Medical Devices” .
MoreThe Medical Device Division will continue the trial to study the feasibility for Local Responsible Persons (LRP),the trial will last until 31 December 2020 for a limited number of listing applications of Class II/III/IV general medical devices.
MoreMDCO has created and developed a Web-based In Vitro Diagnostic Medical Device Classification Program, where previously only the classification program for General Medical Device was available. This is to facilitate the classification of the In Vitro Diagnostic Medical Device according to its risk level under the Medical Device Administrative Control System.
MoreMDCO has revised guidance document related to Importer Listing in Hong Kong, that are GN-07 Guidance Notes for Listing of Importers of Medical Devices, COP-04 Code of Practice for Listed Importers of Medical Devices, and Application for Inclusion on the List of Importers/ Distributors (Form MD-IP+D). This new guidance will be fully implemented start from June 1st 2018.
MoreChina National Drug Administration (CNDA) (formerly known as CFDA) has issued a new policy for Hong Kong medical device manufacturers to enter Mainland China market. CNDA can now accept Certificate of Listing and Certificate to CNDA as marketing approval and Quality Management System certificates which are the necessary documents for medical device registration in China.
MoreMDCO will conduct a trial to study the feasibility for Local Responsible Persons (LRP) to demonstrate that their medical devices conforms with Hong Kong requirement by using marketing approvals obtained from the China Food and Drug Administration.
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