By Dezan Shira & Associates

On June 20, China’s Food and Drug Administration (“CFDA”) proposed the Priority Review Designation Procedure for Medical Devices (Exposure Draft) in an effort to cut through persistent bureaucratic red tape in the medical devices registration process and fulfill China’s rising clinical demand for medical devices.

The Exposure Draft was released after the State Council’s published the “Opinions on the Reform of Review and Approval System for Drugs and Medical Devices” in 2015, which focused on the inefficiency of the medical device approval process. In response, the CFDA proposed a new approval mechanism – Priority Review Designation Procedure– and drafted the eligibility, application, and opposition procedures, as well as other requirements for joining the special treatment.

Priority Review Designation

According to the Exposure Draft, the procedure is limited to medical devices categorized as domestic Class III, imported Class II, or imported Class III. China’s classification regime is based on the risk that a device presents to patients, with Class III reserved for the riskiest, yet most sophisticated devices, such as heart valve prosthesis. Therefore, medical devices categorized as Class III usually go through more costly and time-consuming examination procedures than other classes.

Exclusive to high-end medical devices, the procedure requires these devices satisfy one of the following conditions to be eligible for the Priority Review Designation: enrollment in the National Science and Technology Major Project or National Key Research and Development Plan, or fulfillment of any of the following conditions:

  • Able to diagnose or treat rare diseases, with outstanding clinical advantages;
  • Able to diagnose or treat malignant tumors, with outstanding clinical advantages;
  • Able to diagnose or treat specific and frequently occurring diseases in the elderly, and where there is no effective way to diagnose or treat such diseases at the moment;
  • Able to diagnose or treat specific and frequently occurring diseases in children, and where there is no effective way to diagnose or treat such diseases at the moment; and
  • Able to address an urgent clinical demand while similar medical devices have not been registered in China yet.

The CFDA will seek advice from professionals and grant priority review to other medical devices if necessary.

medical-device-approval-flow-chart

Overview of China’s Medical Devices Industry

The medical device market in China witnessed tremendous growth during the past decade. Sales of medical devices exceeded RMB308 billion in 2015, up more than 50 percent from the previous year. A number of socio-economic factors will continue to drive expansion of China’s medical devices market, including:

  • Aging society: According to the National Bureau of Statistics, China’s elderly population aged 60 and over reached 222 million in 2015, accounting for 1 percent of the country’s total population. The share of Chinese senior citizens is projected to grow to 35 percent by the end of 2050, according to the World Health Organization. With this rapidly expanding aging population, the medical device industry in China is poised for a sustained period of rapid growth.
  • Rising living standards: The per capita disposable income of Chinese urban residents has substantially increased from RMB10,493 in 2005 to RMB31,195 in 2015, according to the National Bureau of Statistics. Improved purchasing power has made health investment more affordable for almost every household in China, further spurring the demand for medical devices.
  • Lopsided market structure: Compared to developed countries, where public spending on medicines and medical devices is roughly equal in size, China favors medicine treatment over medical devices; the market for medical devices is only 14 percent of that for medicine, leaving a large part of the market underserved. If this dynamic changes, as many believes it will, the medical devices market will see another up-cycle.
Long Journey to Reform

Despite myriad opportunities attracting medical device manufacturers and suppliers, the application for medicines and medical devices stacks up on regulatory agents’ desks in the CFDA. In 2015, 21,000 applications were under examination, marking the third peak since 2005, according to CFDA officials. Some medical device companies denounce the standard registration process, which can take up to eight years under the current approval system, arguing that the review process prevents them from entering the market.

China has come a long way in reducing medical devices registration processing time, aiming to make more advanced technologies and devices accessible for the interest of public health.

There are two fast-track review procedures already in effect. In 2009, the CFDA enacted an expedited review process for medical devices applicable to emergency public health incidents. For instance, in an effort to prevent further dissemination of the Zika Virus in China, earlier this year the CFDA granted an accelerated review process for the Zika Virus Test Kit, a technology developed by a domestic medical company called Tianlong. Another fast track approval process was designated for innovative medical devices which must be the first of its kind in China. The intellectual property of the medical device must be acquired in China, however.

Moreover, the CFDA revised its “Regulations on the Supervision and Administration of Medical Devices,” the highest level regulations governing the registration, manufacture, and distribution of medicines and medical devices, and supervising all types of illegal market behaviors. The Regulations stipulate that manufacturers of Class I medical devices only need to submit filings instead of registrations to the CFDA, which will potentially lead to shorter wait times for approval. Furthermore, the CFDA plans to squeeze the initial review of Class II devices to 60 days and Class III devices to 90 days, but these timeframes seem unlikely when external expert reviews or combination device-medicine reviews are involved.

Once enacted, the Priority Review Designation Procedure will be the third streamlined review program. While this can be exciting news for medical device developers and manufacturers, there still remains some uncertainties in the Exposure Draft, such as how much time the procedure can realistically reduce during the approval process. 

With the Exposure Draft already closed to public comment, the official rules from the CFDA are expected to be released soon.

 

This piece originally appeared on Asia Briefing Ltd., a subsidiary of Dezan Shira & Associates. Dezan Shira is a specialist foreign direct investment practice, providing corporate establishment, business advisory, tax advisory and compliance, accounting, payroll, due diligence and financial review services to multinationals investing in China, Hong Kong, India, Vietnam, Singapore and the rest of ASEAN. For further information, please email [email protected] or visitwww.dezshira.com.

Posted by Dezan Shira & Associates