At the 12th AHWP Meeting in Chengdu, PR China, Member Economies were requested to give comments and feedback on the proposed work item for AHWP TC WG01
At the 12th AHWP Meeting in Chengdu, PR China, AHWP TC WG01 presented the review of the CSDT for possible alignment with GHTF's STED. The Meeting decided while the CSDT is being finalized, Member Economies are encouraged to adopt CSDT into their regulatory systems.
The WG01 also presented a work item entitled "Adopting the Principles and Elements of Conformity Assessment for Medical Devices" and implementetaion phases and timelines for WG01's work items. WG01 requested Member Economies to:
(i) reach consensus on adopting the principles of conformity as a fundamental;
(ii) adopt the proposed elements of conformity assessment for medical devices;
(iii) have the commitment to share experienceregulating medical devices; and
(iv) approve the proposed work item for WG01.
The Meeting requested Member Economies to provide comments and feedback on the proposal made by WG01.
Please download the attachment below for the proposal made by WG01 and send your comments and feedback to;
The AHWP Secretariat, c/o Medical Devices Bureau, Ministry of Health Malaysia, Level 4, Block e6, Precinct 1, Federal Government Administrative Center, 62590 Putrajaya, MALAYSIA
Phone: +603-88832301, Fax: +603-88836184, email: email@example.com