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Article 1

To encourage research and support innovation for the development of medical devices, this Procedure was formulated in pursuance to the Regulations on Supervision and Management of Medical Devices, the Measures for the Administration of Medical Device Registration, the Measures for the Administration of In Vitro Diagnostic Medical Device Registration and other laws and regulations.

To encourage research and innovation of medical devices and promote the growth of innovative medical devices, this Procedure is formulated pursuant to Regulations on Supervision and Management of Medical Devices, the Measures for the Administration of Medical Device Registration and other laws and regulations.

Addition of “In vitro” medical devices to the current scope.

Article 2

The Food and Drug Administration department examines and approves Class II and Class III medical devices that comply with the following conditions according to this Procedure:

(1) The applicant, through independent technical innovation, acquires the ownership of invention patents of core technology of products in China according to the law; or acquires the ownership of or the right to use invention patents in China according to law, the patent applying date ( the priority date) shall be within 5 years from applying for the innovative medical device approval procedure; or the applicant applies for the invention patents of core technology of products in China which have been promulgated by the competent patent administrative department under the State Council. Moreover, the search report shall be issued by the Patent Search and Consultation Center of the State Intellectual Property Office. The core technology of the products in the search report are novel and creative.

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The Food and Drug Administration department examines and approves medical devices that comply with the following conditions according to this Procedure:

(1) The applicant, through independent technical innovation, acquires the ownership of invention patents of core technology of products in China according to the law; or acquires the ownership of or the right to use invention patents in China according to the law; or the applicant applies for the invention patents of core technology of products in China which have been promulgated by the competent patent administrative department under the State Council.

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The CFDA limits its scope of approval to Class II and III medical devices, provided that it complies with the conditions set forth in Article II, with an additional premise in Condition 1 where it specifically states that the special approval application shall be done within 5 years from the after obtaining the Patent

Moreover, a search report shall be issued, which contain the core technology of the newly-developed product.

Article 4

The applicant applying for special approval for innovative medical devices before applying for the first application of class II or III medical device, and shall fill out the Application Form of Special Approval for Innovative Medical Devices (see Appendix 1) and submit the data supporting the applied products complying with Article 2 of this Procedure.

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(4) Technical documents for products, at least including:

1. The application environment/ Intended use;

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(5)

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Remove ”The novelty assessment report issued by the information or patent searching authorities”;

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The applicant applying for special approval for innovative medical devices shall fill out the Application Form of Special Approval for Innovative Medical Devices (see Appendix 1) and submit the data supporting the applied products complying with Article 2 of this Procedure.

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(4) Technical documents for products, at least including:

1. Intended use;

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(5) Credentials for product innovation, at least including:

1. The novelty assessment report issued by the information or patent searching authorities;

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The application for special approval of innovative medical devices are limited to Classes II or III only.

Technical documents  shall include all those enumerated in Article 4, with the addition of:

1. Application environment along with the device’s intended use.

And removal of:

1. The novelty assessment report issued by the information or patent searching authorities

Article 5

If the application for special approval of innovative medical devices has been submitted to CNDA, the applicant can apply for withdrawing the application before CNDA makes the review decision, at the same time, the applicant needs to explain the withdraw reason.

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Addition of the following clause:

If the application for special approval of innovative medical devices has been submitted to CNDA, the applicant may apply for withdrawal of the application prior to issuance of review decision. Further, the applicant should provide justifications as to why the registration application should be withdrawn.

Article 6

The Acceptance Center will designate the application serial numbers to the applications for special approval. The application serial numbers will be sequenced as CQTS××××1×××2, of where, xxxx1 pertains to the year when the application is lodged and xxx2 refers to the serial number of the registered product.

The Acceptance Center will designate the application serial numbers to the applications for special approval. The application serial numbers will be sequenced as Device SAP (Special Approval Process) xxxx1-xxx2, of which, xxxx1 is the year when the application is lodged and xxx2 is the serial number of the product when it’s accepted.

The application serial numbers will change its sequence, from:

SAP (Special Approval Process) xxxx1-xxx2 to CQTS××××1×××2, where xxxx1 pertains to the year when the application is lodged and xxx2 refers to the serial number of the registered product.

Article 8

After Acceptance Center accepts the application for special approval for innovative medical devices, the Office will review the application within FORTY working days, and issue the review comment within TWENTY workdays after review the application.

After CFDA accepts the application for special approval for innovative medical devices, the Office will examine the application and issue the review comment within FORTY workdays. If the Office holds that further examination is needed, an Expert Review Committee composed of experts selected from the expert database will be created to reexamine the application and issue the review comment.

Timelines for review and issuance of comments have been included.

Article 10

The CFDA shall notify the application result on the CMDE website. Within the 3 years of the result of special approval application released, the product cannot apply for the special approval application if the product hasn’t been submitted to the registration. The applicant can apply for the special approval application again after 3 years.

The CFDA shall notify the application result in writing and copy it to the local provincial Food and Drug Administration if the applicant is a domestic enterprise (see Appendix 2 for the format).

As opposed to the previous procedure where the application result is notified via written letter, the CFDA, now, shall course through the application result online – via the CMDE website.

Moreover, a separate clause related to rules on reapplication was added, wherein the same isn’t allowed if the product hasn’t yet been submitted for registration. Reapplication for special approval can be done at least three (3) years after the initial application.

Article 13

In testing the innovative medical devices, the medical device testing organization shall timely pre-assess the standards of product registration submitted by the applicants and give suggestions for modifications of any problem.

In testing the registration-type test of innovative medical devices, the medical device testing organization shall timely pre-assess the standards of product registration submitted by the manufacturing enterprises and give suggestions for modifications of any problem.

The scope of the article included all types of testing (registration-type or entrust-type).

Moreover, the term “manufacturing enterprises” was replaced with “applicants” which implies that all importers/authorized representatives/ or any natural person representing the manufacturer’s behalf, are authorized for device testing application.

Article 14

The medical device testing organization shall deal with the type-testing of medical devices with priorities after accepting the sample and issue the testing report.

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The medical device testing organization shall deal with the registration-type test of medical devices with priorities after accepting the sample and issue the testing report.

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The medical device testing organization shall deal with all forms of type-testing, either registration-type or entrust-type.

Article 22

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(4) The application for the invention patent of the core technology was rejected or deemed to be withdrawn.

(5) Losing the invention patent right or the usage right of the core technology of the product.

(6) The application product is no longer managed as a medical device.

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(4) The application is not suitable for management according to this Procedure after discussion of the Expert Review Committee.

CNDA add some situations that not applicable to apply the special approval process.