How to Compile Medical Device Software Describing Documents for CFDA Registration (with the sample document created by CIRS)

According to the ‘CFDA Medical Device Software Registration Technical Audit Guide Principle Announcement (2015the 50^th Statutes)’issued in August 5^th 2015, all the class II and class III medical devices that include software should provide software describing documents for the initial CFDA registration. The details and clause requirements for the software describing documents depend on safety level and developing modes differences.

Three kinds of software used in the medical devices and document requirements for the CFDA regisration.

I. Self-developed medical device software: software describing documents should include basic information, realization process and core algorithm. (Click for sample document created by CIRS). (Contact CIRS at md@cirs-group.com for the English version sample document)

II. Partial ready-made medical device software
For the partial ready-made software used medical devices, based on the safety level, the documents should be provided by the medical device manufacturing companies.
Chart 1

Safety Level	A Level	B Level& C Level
Describing Document Requirements	Software Identification, structural function, risk management, verification, validation and history updating	Software Identification, structural function, requirement specifications, risk management, life-cycle, verification, validation, defect management, history updating and core algorithm

III. Completely ready-made medical device software
There are requirement differences among three kinds of read-made software.

Ready-made software (without special order): manufacturing companied should provide the copy or statement of outsourcing contract, software describing documents. If the ready-made software already accessed Chinese market, companies should provide the registration copy.
Legacy software: the manufacturing companies should provide certification of legacy software (ex: YY/T 0664 or IEC 62304), software describing documents, Post-marketing clinical evaluation information.

Ready-made software (with special order): manufacturing companied should provide the copy or statement of outsourcing contract, software describing documents.

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