In the near future, Guangdong Provincial Medical Products Administration will, based on in-depth research and repeated demonstration, take the lead in changing the medical device registrants in group companies nationwide. The registration items will be changed for the change of registrants in group companies that meet the conditions of being involved in the pilot Guangdong medical device registrant system, no change in product quality related elements, effective transfer quality management system and product technical documents and clear subjects responsible for the quality of commercially available products. This will certainly further optimize the internal resource allocation of group companies, stimulate innovation and creativity in enterprises and boost the high-quality development of the medical device industry in Guangdong, contributing to the nationwide promotion of the medical device registrant system.
Since the pilot implementation of the medical device registrant system in Guangdong, Guangdong Provincial Medical Products Administration has made remarkable achievements through aggressive reformation. As of the end of September this year, one pilot application of one company for Class III medical device and 43 pilot applications of three companies for Class II medical device have been approved, and more than 50 companies have the intention to pilot for over 110 varieties.
Since the pilot implementation of the medical device registrant system in Guangdong, Guangdong Provincial Medical Products Administration has made remarkable achievements through aggressive reformation. As of the end of September this year, one pilot application of one company for Class III medical device and 43 pilot applications of three companies for Class II medical device have been approved, and more than 50 companies have the intention to pilot for over 110 varieties.