Medical devices manufacturer and distributor must establish and follow the medical device quality management system, the quality management system are known as Good Manufacturing Practices (GMP) for manufacturer and Good Supplier Practices (GSP) for distributor.
China has implemented the GMP on sterile and implantable medical devices from Jan, 1st 2011 and it will be expanded to all medical devices manufacturing until Jan. 1st 2018 according to NMPA notice No.15-2014. The more information about the GMP implementation in China can be found here.
On Dec, 12th 2014, NMPA released the 58th Announcement on the implementation of GSP. It indicated that all distributors were required to establish the quality management system corresponding to the GSP to ensure the quality safety in the process of procurement, inspection, storage, transportation, sale, after-sale service.
How to comply with the quality management regulations in China?
Quality management shall involve in the full product life cycle. Companies need to know what obligations or regulations to fulfill firstly, then to establish your own appropriate quality management system and follow it.
If you would like to have a local QM responsible person to deal with the regulatory compliance and quality management, please feel free to contact us.