The risk of Implantable medical device is higher, and the supervision is strictest. The classified level is III, and medical device code is 6846. CFDA has issued relevant documents about quality system for manufacturing enterprise in succession, and regulate the links such as research, manufacture, distribution, usage and so on.
In order to ensure the quality of medical device, companies shall complement corresponding quality management standard according to issue time nodes of following regulation.
History of manufacturing quality system of implantable medical device
In order to ensure the quality of medical device, companies shall complement corresponding quality management standard according to issue time nodes of following regulation.
History of manufacturing quality system of implantable medical device
Issue Time | QS Name | Implementing Time | Regulation Name | Application Range |
Sep 24th,2002 | Detailed Rules of Manufacture for Surgical Implantable Medical Device | Oct 1st,2003-Sep 31th,2011 | Announcement on Detailed Rules of Manufacture for Surgical Implantable Medical Device (No.473 Announcement of 2002) | Manufacture, Supervision, Registration |
Sep 16th,2009 | Medical Device Quality Management System Detailed Rules for Implantable Medical Devices | Jan 1st,2011-Sep 30th,2015 | Announcement on Promulgation of Medical Device Quality Management System Detailed Rules and Medical Device Quality Management System Inspection Standards for Implantable Medical Devices (interim) (No.836 Announcement of 2009) | Manufacture, Supervision, Registration |
Jul 10th,2015 | Good Manufacturing Practice for Medical Devices Appendix for Implantable Medical Devices | Oct 1st, 2015 | Announcement on Promulgation of Good Manufacturing Practice for Medical Devices Appendix for Implantable Medical Devices (No.102 Announcement of 2015). | Manufacture, Supervision, Registration, Review, Manufacture review |
Good Manufacturing Practice for Medical Devices Appendix for Implantable Medical Devices will come into effect as of October 1, 2015. The requirements of Good Manufacturing Practice for Implantable Medical Devices as following:
Item | Specific Requirements |
Staff | Capability requirements, Professional knowledge in training, Cleanliness requirements of staff, Health record of staff, Clothing requirement of staff |
Plant Facility Layout | Requirements of plant environment, process arrangement, cleaning workshop layout and level. Cleanliness requirements of different product process, protective clothing, cleaning tools, tooling device. Antipollution requirements of cleaning room. |
Equipment | Cleanliness requirements of equipment and process water. |
Design & Development | Safety risk control measures of different design & development. |
Procurement | Requirements and verification of purchase product and primary package. Requirements for supplier of medical device of animal origin and allogeneic medical device. |
Manufacturing Management | Safety protection, Sanitary control for cleaning room, additives management, working position apparatus management. The requirements of the materials and parts of product which enter into cleaning room, as well as process certification, batch number, label, traceability, etc. |
Quality Control | Requirements of inspection room, process water, cleaning room environment, original polluted bacterium and particle, inspection institution, reserved sample. |
Market | Sales and distribution record. |
Adverse Event Monitoring, Analyzing, Improving | Adverse event collection and analysis. |
With the release of the new regulations, companies shall notice the Requirement of Good Manufacturing Practice for Implantable Medical Devices while implementing the Good Manufacturing Practice for Medical Devices.