Decree 83 Innovation Approval Procedure

Appendix
Article 1
This procedure is stipulated to guarantee the safety and effectiveness of medical devices, encourage the research and innovation of medical devices and promote the distribution and
application of new technologies of medical devices, in accordance with Regulations for the
Supervision and Management of Medical Devices, Provisions for Medical Device Registration
and Provisions for In-vitro Diagnostic Reagent Registration. Article 2
For Class II and III medical devices applicable for all the following situations are reviewed and
approved according to this procedure by the Drug Administrations:
(1) As the leading person of the technical innovation, the applicant has the patent for invention
of the core technology of the declared products, or obtains the invention patent or right of use
in China legitimately through transfer and acceptance, and the application date (or the priority
date if available), and the patent being within 5 years after the application of Innovative
Medical Devices Special Approval Procedure; or the application for the patent of the core
technology has been made known to the public by the Patent Administration Department
under the State Council, and corresponding search report which presents the novelty and
creativity of the core technology protocol has been provided by the Patent Search and
Consultation Center of the State Intellectual Patent Office. (2) The product stands out for: its main working/action principle has never been created before
in China; its performance or safety undergoes radical improvement in comparison with its
similar products; the product is technically leading the world and clinically applicable and
significant. (3) The applicant has completed the preliminary research and products fundamentally finalized
are available. The researching process is real and controlled. The research data is complete and
traceable. Article 3
The innovative medical devices are granted the priority to be reviewed and approved and the
by the Drug Supervision and Administration Department and related technical agencies
according to their respective duties and this procedure based on the principle of early
intervention, customized service by designated personnel and scientific approval without
shrinking relative standards and the procedures. Enhance the communication with the
applicant. Article 4
Innovative Medical Device Special Approval Procedure
For the application of special approval of the innovative medical devices, the applicant shall fill
out the Application Form for Special Approval of Innovative Medical Devices (see Appendix 1), and submit materials demonstrating the declared product subject to requirement of Article 2 of
this Procedure prior to the first registration application for Class II and III medical devices. The
materials shall include:
(1) Qualification documents of applicant as the legal person of the enterprise. (2) Status of the intellectual property of the product and related supporting documents. (3) Process of product development and summary of the results. (4) Technical documents of the products shall at least include:
i) Indication/intended use of the product;
ii) Working/action principle of the product;
iii) Main technical indicators and of the product and its evidential basis, requirement for the
indicators of main raw material and key elements, main manufacture process and flow chart, as
well as examination method of main technical indicators. (5) Supporting documents of product innovation, at least including:
i) Academic papers, monographs and document summaries published in core journals fully
demonstrating the product is clinically significant.
ii) Analysis and comparison of similar products marketed at home and abroad for their
application conditions.
iii) Innovation of the product and its significant clinical application. (6) Risk analysis materials of the product. (7) Instruction for use (draft). (8) Other materials demonstrating the product subject to the materials of Article 2 of this
procedure. (9) Overseas applicant shall entrust a domestic legal person of body of enterprise as their
agent, or perform the application through their office in China, and the following documents
shall be submitted:
i) Letter of authorization that the overseas applicant entrusted to their domestic agent or
administrative office in China to perform the application for the special approval of innovative
medical devices;
ii) Letter of commitment of the domestic agent or the administrative office of the overseas
applicant;
iii) A copy of business license of the agent or the registered certificate of the domestic office of
the overseas applicant. (10) Self-assurance statement of the authenticity of the submitted materials. The application materials shall be in Chinese. If the original materials are in foreign language, a
Chinese translation version is required. Article 5
Domestic applicant shall submit their applicant to the provincial drug supervision and
administration department for the special approval of the innovative medical device. The
provincial drug supervision and administration department will conduct the preliminary
examination to decide whether the declared product conform to the requirement of Article 2 of
this procedure, and the result is given within 20 working days. If the result turns out be non- conformity, the department will inform the applicant; if the result is the otherwise, the
provincial drug supervision and administration department will submit the application materials
and their preliminary examination opinion together to the State Drug Administration
(hereinafter referred to as SDA) Administrative Service Center. Overseas applicant shall submit their application directly to the SDA for special approval of
innovative medical devices. The SDA Administrative Service Center will conduct a formal
examination on the submitted materials, of which meet the requirement of Article 4 of this
procedure are accepted for review. For such application that is accepted, the applicant can withdraw their application and related
materials, and give the reason for that withdrawal before the decision of the review is made. Article 6
The application for special approval accepted by the SDA Administrative Service Center is
further assigned an acceptance number for special approval. The numbering method of
acceptance numbers is: CQTS××××1×××2, where ××××1 is the application year; and ×××2 is the
product serial number. Article 7
Center for Medical Devices Evaluation of State Drug Administration (hereinafter referred as
CMDE) set up an Innovative Medical Device Examination office, which will conduct the review
of the special approval application of innovative medical devices. Article 8
With the acceptance of special approval by the Administration Service Center of the State Drug
Administration, the Innovative Medical Device Examination office will gather a panel of
specialties for the review who will conduct the review within 40 working days and provide their
review opinion within 20 working days with the completion of the review. Article 9
With the examination of the office, the names of the applicant and the product of the special
approval shall be published in CMDA website and maintained for at least 10 working days. If
there are objections to the published information, a research of relative opinions prior to the
final review decision is recommended. Article 10
After decision of the review is made by the Innovative Medical Device Examination office, the
applicant is notified through the CMDE website.
In 5 years after the publication of the review result, for the corresponding medical devices not
applied for registration, this procedure is not applied to the performance of the review and
approval for it. 5 years after the result is published, the applicant conduct the reapplication of
the special approval for the innovative medical devices according to this procedure. Article 11
Innovative Medical Device Examination office can conduct the review of the special approval
for the innovative medical devices together with the definition of the medical device
management categories. For the application of domestic enterprise, if their product are defined
as Class II medical devices, they can be reviewed and approved by corresponding provincial
Drug Administration department according to this procedure. Article 12
For innovative medical devices with the approval to be reviewed according to this procedure, the local drug supervision and administration department where the applicant locates shall
designate certain person at the request of the applicant for communication and consultation. In
the examination of the quality management system of the applicant, the priority is given to the
applicant as required. Article 13
For the examination of innovative medical devices, medical device inspection agency shall
conduct the pre-evaluation on the product technical requirement provided by the
manufacturer in time and a timely feedback to the applicant is desirable. Article 14
The medical device inspection agency shall give the priority to the examination after
acceptance of the samples and provide examination report. The technical requirement with
pre-evaluation and the pre-evaluation opinion shall be sealed the same with that on the
examination report and be provided together with it. Article 15
The clinical trial of innovative medical devices shall be conducted in accordance with related
specification. The Drug Supervision and Administration department shall conduct
corresponding duties according to the progress of the clinical trial. Article 16
The applicant shall conduct an evaluation of influence of the alternation on the safety, effectiveness and quality controllability of the medical devices for clinical research of innovative
medical devices necessitating significant alternations, such as revision of clinical trial protocol, usage, models and specifications, intended use, indication or adjudgment of subjected
population. If the innovative medical devices are changed in the terms of main working or
action principle, the product shall be reapplied according to this procedure.