The National Medical Products Administration of China issued special review procedures for innovative medical devices in November 2018, effective December 1, 2018. The procedures enable expedited regulatory approval of innovative medical devices when the applicant owns or licenses Chinese invention patent applications directed to the medical devices seeking approval.

Requests for participation in the special review program will be issued within 60 working days and have an opposition period of 10 working days. Once requests are approved, applicants can request expedited regulatory device approval within five years of the approval.

Official data for 2019 has not been released yet. But by the end of 2018, 197 products were successfully entered the special review process, with 54 approved.

Expedited reviews have shortened the process by an average of 83 days compared to conventional regulatory approval. In some regions, the effect of the expedited review can be even more significant. For example, in Beijing there is a green channel for this process, and the average time period for the review procedure has been shortened from 170 days to 22 days.

Requirements

The requirements to apply for special review include:

Patent

The applicant must be a patentee of a Chinese patent, be assigned the patent, or be licensed to use the patent in China. The valid patent must have been granted less than five years. Alternatively, a published patent application can also be used if it is accompanied by a search report from the Consultation Center of the China National Intellectual Property Administration indicating that the claims are both novel and inventive. The procedure will be terminated if patents are invalidated, the applicant loses a license to the patents, or all patent applications have been abandoned or rejected.

Completeness

The applicant has completed preliminary research of the product and the basic product is essentially determined. All data (not necessarily clinical data) is complete and traceable.

Technical Advantage

The medical device must be new to China (but can be available outside of China), performance or safety must be fundamentally improved compared to similar products, it must be a world-leading technology, and it must have significant clinical value.

Patent Strategies

As having a Chinese invention patent or published Chinese invention application with a positive search report is a major requirement, applicants should consider strategies to expedite grant of their Chinese invention patent.

For example, to minimize patent prosecution, that is, to grant without the back and forth of office actions and responses with the China National Intellectual Property Administration that can take years, applicants should file an application with extremely narrow patent claims and optionally divisional application(s) seeking broader claim coverage. Only one patent is needed and so family members can take longer to prosecute for broader coverage without harming the request to participate in the expedited regulatory approval. Note that generally divisionals of divisionals are not allowed (e.g., except for unity rejections) so one should make sure to file any divisionals needed before grant of the base application.

Another option is to participate in prioritized examination in China. Prioritized examination provides for a first office action within 45 days of approval to participate and to conclude examination within one year of approval. Accordingly, using narrow claims in conjunction with prioritized examination can potentially lead to a grant within just a few months. Patent applications eligible for prioritized examination include:

Industries considered priorities for national development, such as energy conservation and environmental protection, new-generation information technology, biology, high-end equipment manufacturing, new energy, new materials, new energy vehicles and intelligent manufacturing;

• Industries encouraged by governments at provincial and municipal levels;

• Internet, big data, cloud computing and related fields where the technology is changing rapidly;

• A patent applicant or reexamination petitioner has prepared for implementation, has begun to implement or has evidence to prove that a third party is implementing its invention and creation;

• A patent has been filed in China for the first time and further filed in other countries or regions for the same subject matter; and

• Other circumstances with great significance to national or public interest.

Finally, a third option is participation in the Patent Prosecution Highway. China will expedite examination of an invention patent application in a manner similar to prioritized examination based on allowance in another jurisdiction that has an agreement with China.

For example, once the U.S. Patent and Trademark Office allows a U.S. application, an applicant can then participate in expedited examination via the PPH in China. To get a quick allowance in the U.S., applicants can file a U.S. application and file a request for prioritized examination (or petition to make special base age, health, etc.). Current USPTO statistics indicate only 5.3 months from petition grant to allowance for U.S. prioritized examination. While the China patent office will not give deference to the U.S. examination results, if the U.S. and Chinese claims are narrow, the China patent office may quickly grant the corresponding Chinese application with a minimum of prosecution.

Application Requirements

Applications for the special review should include:

1. Applicant’s enterprise certificate of incorporation.

2. A list of intellectual property of the medical device and supporting documents.

3. Overview of the medical device development process and results.

4. Medical device technical documents including:

• The applicability or intended use of the medical device;

• The working principle or action mechanism of the medical device; and

• The main technical specification of the medical device and the basis thereof, the specification of the main raw materials and key components, the main production process and flowchart of same, and the assays for the main technical specification.

5. Supporting documents for the innovative nature of product, including:

• A summary of academic papers, monographs and documents published by core journals that effectively support the clinical value of the product;

• Analysis and comparison of similar medical devices available in China and abroad (if any); and

• The innovative point of the product and the significant clinical value.

6. Medical device risk analysis data.

7. Medical device manual (draft).

8. Other materials certifying that the medical device complies with the requirements mentioned above.

9. A declaration on the authenticity of the materials submitted.

Application Process

Chinese applicants should submit their applications to the provincial drug regulatory department in their locality, which will issue a preliminary review opinion within 20 working days and forward same to the National Medical Products Administration. Foreign applicants should submit their applications directly to the National Medical Products Administration. The Innovation Medical Device Review Office of the National Medical Products Administration will then issue an initial decision within 60 working days of receiving the application (either directly from a foreign applicant or forwarded by a provincial drug regulatory department).

The National Medical Products Administration will then publish the initial decision online for a 10-day opposition period. If there any objections, the National Medical Products Administration will make a final review decision after reviewing any objections although no timeline is provided for issuing a final review decision if there are objections.

The National Medical Products Administration will then publish the final review decision on its website. Applicants will then have five years from publication to apply for expedited regulatory review. After five years, applicants will need to reapply to participate in the special review procedures.

The National Medical Products Administration can terminate the procedure if:

• The applicant has voluntarily requested termination;

• The applicant fails to perform the corresponding obligations in accordance with the prescribed time and requirements;

• The applicant provides forged or false information;

• All the invention patent applications on the key technology are rejected or deemed to be withdrawn;

• Loss of patent right (e.g., invalidation or assignment to third party) or loss of license of all the invention patents on the key technology of the product;

• The medical device is no longer regulated as a medical device; or

• The National Medical Products Administration determines the procedure is inappropriate.

Conclusion

The most popular medical devices approved generally fall into categories of implantable medical devices (e.g., stents, valves) and in-vitro diagnostics (e.g., cancer diagnostic kit, disease-related gene mutation detection kit, etc.). Specific examples of approved devices include EGFR mutation detection kit, PET imaging device, and gene sequencer.

Note that while the special review procedures supersede the 2014 special approval procedures for innovative medical devices, other avenues for expedited regulatory approval are available such as the medical equipment emergency approval procedures for public health emergencies, prioritized review procedure for medical devices for treatment of orphan and other diseases, and urgent review process of medical devices (e.g., for Influenza A H1N1 detection kit).

Bin Zheng also contributed to this article