In 1992, medical device government competent department and industry representatives from America, European Union, Japan, Canada and Australia held the first GHTF meeting. After that the meeting was held annually.
The meeting is aimed at exchanging medical device supervision and management situation with other countries and discussing related regulation and technology standa*** so as to achieve the basic agreement of other countries and eliminate unnecessary barriers in the medical device trade center.
There are four teams in GHTF regulation which is resp***ible for discussing and drafting documents:
The first research team is resp***ible for coordinate works of medical device management regulation system.
The second research team is resp***ible for coordinate works of supervision and warning system after entering the market.
The third research team is resp***ible for medical device quality system.
The fourth research team is resp***ible for coordinate works of medical device quality system verification.
O***unda medical device c***ulting organization (Guangzhou, Beijing, Shanghai, Suzhou, Shenzhen and Jinan), investing in China from Canada, is professionally engaged in medical device regulation c***ulting, medical device registered agent, medical device management system certification and product certification, focusing on providing medical device enterprises international medical device registration（CE、FDA、CMDCAS、TGA、JPAL、SFDA、PPE）、medical device system certification（ISO13485、YY/T 0287、GMP、QSR820、GSP）,doing second and third party audit for medical device suppliers, providing detail information of c***ulting the medical production manufacturing license.