HONG KONG – Chinese med-tech regulators said in December that conditional approvals are now available to medical devices after the government created speedy review channels for devices that the country needs.

Med-tech firms that are granted the conditional approval will still have to complete their clinical trials within a time frame, the National Medical Products Administration (NMPA) of China said.

The goal of the new guidelines is to address the need for treatment of life-threatening diseases and speed up the review and approval of clinical devices. The basic principles of the guidelines make it clear that they will offer more flexibility on the requirements of clinical trials and data collection, while keeping comprehensive safety evaluations strict.

China is constantly updating its fast-track system for medical devices, Grace Fu Palma, CEO of China Med Device LLC, a Boston-based medical device & IVD consulting firm, told BioWorld MedTech that the update serves to address two main issues:

“The first one is to shorten the premarket time for clinical trials,” she said. “Painstaking clinical trials usually takes 12 to 18 months to obtain the clinical data. By utilizing conditional approval, devices and IVDs can be approved without enough clinical data, if manufacturers are committed to do further clinical research. NMPA is paying more attention to post-market evidence.”

“The second one is prioritizing innovative products,” she continued, adding that the reviewing process is slow due to a shortage of reviewing staff and a backlog of applications. According to the 2018 NMPA Registration Annual Report, the NMPA received 6,608 applications.

“If one of the three fast-track designations is granted, an application will be allocated ‘front-of-queue’ priority throughout the registration process, thus shortenening the time for market introduction to address unmet medical needs,” Palma added.

The three fast-track channels that Palma mentioned are innovation approval, priority review, and emergency approval, and have been in place since 2014. The procedure has reduced the product registration period by 83 days.

The first channel for innovative medical devices covers class II and class III devices with significant clinical application value. Applicant must own a valid invention patent and China Patent & Trade Office coverage, complete the preliminary study of the prototype with traceable data and be an authorized in-country legal entity.

Meanwhile, applicants that aim for a priority review must ensure their devices can treat rare diseases, malignant tumors or geriatric diseases that lack effective diagnosis or treatment. In other cases, the devices must be intended for pediatric diseases with significant clinical application value.

And the third channel, known as an emergency approval, requires applicants to have medical devices intended for public health crises when there is currently no effective product and they must also be intended for unmet medical needs.

From 2014 to June 2019, 222 products have been given priority review. Among those products, 65 have been approved, of which 64 were developed by Chinese med-tech companies.

These products include the Castor Branched Aortic Stent-Graft System developed by Shnaghai-based Endovastec Medtech Co. Ltd., and the J-Valve transcatheter aortic valve implantation system developed by Jc Medical Inc.

However, med-tech companies will have to remain cautious when tapping into the China market as the country will maintain strict standards for qualification. Overseas manufacturers who are keen to make a foray into the Chinese market will have to bear in mind a few things, Palma advised.

“First of all, having been granted ‘status’ does not mean ‘approval’. With ‘front-of-queue’ priority, they still must go through the normal review process. Also, the NMPA gives overseas manufacturers equal opportunity to access the fast-track channels. There is no difference as to the qualifications for domestic manufacturers vs. the overseas ones,” she said.

She noted that 37 products have been granted Innovation Device Status as of the beginning of December this year. Eight of them are imported devices.

“In addition, foreign manufacturers can initiate an innovation approval application at the same time as when applying for China Patent & Trade Office coverage. An application does not have to be made after getting the patent,” Palma added.

Similarly, she said that conditional approval does not only apply to the three fast-track channels.

For example, 3D-printed medical devices are also included. When there is no previous device to us as a comparison, no readily available referenced devices and only limited patient volume, the NMPA only asks for 10 to 20 pairs of an observatory study.

“It can be used in conjunction with historical data to do the general analysis. A three-month observational study follows to determine the clinical benefits. It relies on post-market follow up evidence due to it having such a short endpoint and small sample size,” she added.

In conclusion: China has radically reformed its medical device registration process, and greatly sped up the time taken for a device to reach market from when a first application is lodged. This is highly encouraging for med-tech device companies, as it considerably reduces what can be a very time-consuming and expensive period in the cycle of medical device development.

No Comments