Release for Public Comment – Registration Requirements for Innovative Medical Devices – China FDA
“The Requirements of Application Materials for Special Approval of Innovative Medical Devices (The Draft)”, published by National Food and Drug Supervision and Administration of Medical Evaluation Centre on May 3, 2016, is now soliciting for public comments until the deadline on May 31, 2016. Following is our analysis of The Draft
Let us have a look at the flowchart of application procedure for innovative products, which is specified by the “Special Approval Procedure for Innovative Medical Devices (Draft)”, enacted since March 1, 2014.
The original of “The Requirements of Application Materials for Special Approval of Innovative Medical Devices (Draft)”
The requirements were drawn up on the basis of “Regulation on the Supervision and Administration of Medical Devices”, “Measures for the Administration of Registration of Medical Devices”, “Circular on Printing and Issuing the Measures for the Administration of In-vitro Diagnosis Reagent” and “Special Approval Procedure for Innovative Medical Devices (Trial)”, to standardize application for special approval of innovative medical devices, improve the quality of application materials, and promote development of medical device innovation.
Requirements of the content
1.Application form for Special Approval of Innovative Medical Devices
The form should be duly completed by the applicant.
To avoid ambiguity, applicant should concisely, and as appropriate, include all important information about product’s functions structure, composition, working principle/mechanism of action and intended use.
2.Relevant materials of all past application for Special Approval of Innovative Medical Devices(if applicable)
For the re-application of innovative medical devices, the copies of the “Notices of Review of Special Approval for Innovative Medical Devices” of all the previous submissions are required, as well as any official statement of product change as well as change in materials.
3.Certificate of qualification of the applicant’s legal entity
a. For domestic applicants: Copies of the Enterprise Business License and copies of the Organisation Code Certification of the company are needed.
b. For overseas applicants: Applicant should submit Certificate of Qualification of the Legal Entity issued by authority of the country (region) where he/she registered, which should be duly signed and sealed by the original issuing authority or be notarised by the local notarisation institute.
4.Intellectual property rights and technical documentation of the product
a. Provide an illustration of the intellectual property of core technologies of the innovative medical device. If there are several patents of invention, suggest making a list which presents information such as names of patents, patentees, patent status etc.
b. Provide relevant documentation of intellectual property rights.
I. For applicants who have obtained patent rights, patent authorisation with the applicant’s signature and seal, patent claim, copies of the manual, the original and copies of patent register are required.
II. For applicants who legally obtain the transferred right to use the patent, the original “Certification of Licensing Transfer of the Patent” issued by the relevant patent department is also required, in addition to the patent authorization with applicant’s signature and seal, patent claim, copies of the manual, the original and copies of the patent register.
III. If the application of the patent has been made public by the patent administration department under the state council, but has not been authorised, copies of documentation with applicant’s signature and seal (such as notice of publishing patent application, notice of publishing patent application and entering in substantive examination, notice of substantive examination of patent application) is demanded as well as the claim of published version and copies of manual, which can prove the patent’s publicness. If the claim and the manual are modified by request of patent examination department during the examination process, modified text should be submitted; if patentee has changed, documentations issued by patent administration such as copies of Notice of Contract, should be submitted.
5.Review of research and development process of the product and its results
Review the original project of research & development and lab studies, animal experiment studies, clinical researches that have been carried out and the results of them. Submit a comprehensive report which product’s R&D information including design input, design verification and design output.
6.Product Technical Documentation
a. product’s intended use;
I. Intended treatments, diagnosis and other purposes in compliance with Regulation on The Supervision and Management of Medical Devices should be clearly specified, whose applicable medical phases (such as post-treatment monitoring, recovery, etc.) can also be described.
II. Explain whether the product is disposable or reusable;
III. Specify medical devices that are intended to use in combination with the product;
IV. Provide information about targeted group of patients (such as adults, children or newborns), patients’ standard of selection, parameters which demand monitoring and factors which should be taken into consideration during the process of operation.
b. product’s operating principles/ mechanism; account of the operating principles/ mechanism which realise product’s intended use; Information about related basic research.
c. Specify product’s main technical index and evidence of verification, main materials, index conditions of key component, procedure and flowchart of main production techniques, main technology guidelines and testing methods.
7.Documentation of Product Innovation
a. novelty assessment report issued by information / patent retrieval organisation. It refers to technological novelty assessment report issued by information retrieval organisation in China, or novelty report issued by patent retrieval organisation, which can prove the innovative point, level and reason of the product. The novelty assessment report is valid for 1 year.
b. academic research papers, monographs and document reviews published by core journals which clearly prove the value of clinical application. Literature and documents about the product can be provided, along with that of an equivalent product overseas.
c. analysis and comparison of applying condition among similar products on the market at home and abroad.
I. Description of the retrieval of similar products on the market should be provided, normally including retrieval database, retrieve date, keywords and results of each key word. Analysis of differences of operating principles/ mechanism between applicant innovative medical device and other similar products on the market is also needed.
II. Description the similar products in the overseas market, analysis of similarities and differences between them and the product should be provided, in addition to analysis and comparison that can prove that the product technology is in the leading edge of the industry.
d. product’s innovation and notable values of clinical application
I. innovative review of applicant medical device
II. Explain the innovation of applicant medical device. Address notable values of clinical application and the fundamental improvement on the safety, efficiency and energy saving through innovation compared to existing products and treatment methods.
III. supporting documents
8.Risk management report of the product
a. findings of previous risk management process based on the product
b. writing referring to “Application of Medical Device Risk Management on Medical Device” YY/T0316
9.Product manuals(sample sheets)
It should comply with relevant requirements of “Regulations of Manuals and Tags of Medical Devices” (General Official’s Order No.6)
10.Other relevant supporting evidence which adheres to the 2nd requirement of“Special Approval Program for Innovative Medical Devices (Draft)”
If the product or its core technology have won any national or provincial award, please specify and submit copies of related documentation.
11.Application request from overseas applicants who entrust their legal entity in China or from office in China
a. proxy in which overseas applicant which had entrusted his/her agent or office in China to apply for special approval of medical devices;
b. undertaking of the agent or the applicant’s office in China;
c. agent’s business licence or registration certificate of applicant’s office in China
12.Self-declaration of the authenticity of the submitted materials
For domestic product application, it should be provided by applicant. For imported product application, it should be provided respectively by applicant and his/her agent.
a. The declared documents should be arranged in order according to the requirements and afterwards be bound into a book form.
b. There should be catalog for submitted documents, including the first- and second-level headings. Documents corresponding to each second-level heading should have separate pages.
c. Unless otherwise noted, declared documents for special approval of domestic innovative medical devices should be original with applicant’s signature and seal. Signature and seal means: company seal, or company seal with signature of his/her legal representative/manager.
d. Unless otherwise noted, original text of declared documents for special approval of imported innovative medical devices should be signed and sealed by applicant, and the Chinese version signed and sealed by his/her agent. Signing and sealing of the original means: signature of applicant’s legal representative/manager, or signature with seal of organisation, meanwhile submit notarisation provided by notary authority in the applicant’s residence; signing and sealing of the Chinese version means: agent sealing with company chop, or applicant’s legal representative/manager signing and sealing with company seal.
e. Files made by applicant should be printed in A4 paper with legible font.
f. If needed, copies of declared documents should be clear and conform with the original. Coloured pictures and graphs should be provided with coloured duplicate.
g. Declared documents are in Chinese. If the original text is in a foreign language, Chinese version should also be provided.
h. If the original documentation declared have been submitted in the previous application for special approval of innovative medical devices, applicant can provide copies of these declared documents with the applicant’s signature and seal, along with documentation which states the numbers of acceptance of the original’s application documents.
The applicant shall submit electronic format of the documents below (not editable, such as pdf):
a. application form of special approval for innovative medical device
b. review of innovation of the applicant medical device
c. technical documentation of the product