How to implement the quality systems for implantable medical device company

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

Issue Time	QS Name	Implementing Time	Regulation Name	Application Range
Sep 24^th,2002	Detailed Rules of Manufacture for Surgical Implantable Medical Device	Oct 1^st,2003-Sep 31^th,2011	Announcement on Detailed Rules of Manufacture for Surgical Implantable Medical Device (No.473 Announcement of 2002)	Manufacture, Supervision, Registration
Sep 16^th,2009	Medical Device Quality Management System Detailed Rules for Implantable Medical Devices	Jan 1^st,2011-Sep 30^th,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 10^th,2015	Good Manufacturing Practice for Medical Devices Appendix for Implantable Medical Devices	Oct 1^st, 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.

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