Medical Device Regulatory Updates in China and Japan
BY HUYEN NGUYEN, OCTOBER 9, 2006
Asia's continued economic growth makes it an attractive market for both the sale and manufacture of medical devices. Pacific Bridge Medical, a medical consulting firm focusing on business development and regulatory affairs in Asia, recently published an article on the regulatory updates in the Chinese and Japanese medical market. We have highlighted some of these advances for you below.
China
As China's economy moves into the 21st century, its medical device, implant and manufacturing sectors will experience high levels of growth. Domestic and foreign medical device companies will look to China's market for product opportunities. With 2008 Olympics on the horizon in Beijing, the country is trying to show the world that it is commited to growth by bringing medical device regulatory policies up to world standards.
In 2002, China began revising its regulatory policies and regorganizing the regulatory authority, the State Food and Drug Administration (SFDA). Since then the SFDA has cracked down on bribery and corruption while making sure devices are manufactured according to specifications required by the SFDA. This regulatory body is trying to improve the quality of medical device testing, standardize the registration of electrical medical equipment, increase the number of medical device documentation inspections, establish a new pricing policy for medical devices, stregthen the supervision of medical device manufactuers and implement new regulation on medical device quality systems management.
Japan
Like China, Japan's regulatory policy for medical devices has also undergone significant change.
The Pharmaceutical Affairs Law (PAL) was enacted on April 1, 2005 and governs all designs and approvals processes for medical devices. The PAL calls for new labeling requirements for medical devices and more comprehensive medical device registration requirments.
The Ministry of Health, Labor, and Welfare (MHLW) serves as the regulatory authority along with the Pharmaceutical and Medical Devices Agency (PMDA). Earlier this year MHLW reduced the reimbursements on medical devices and drugs (prices were cut by 0.2% on a cost basis, translating into an average price cut of 13% for hip, 7% for knee, 12% for trauma and 5% for spinal implants.)
Earlier this year, many of the domestic and foreign medical device industry representatives met with the PMDA to provide feedback on the Japanese government's medical device policies. Some of the topics included:
Establishment of unofficial discussion committees to accelerate approval prcess (similar to exisiting pharmaceutical committees) for devices approved outside Japan and increase number of approval staff
Enhanced flexibility in using foreign clinical trial results for device approvals and the promotion of global and physician-guided clinical trials
Facilitating the use of good clinical practice and quality management systems
Creating national centers to provide leadership and a standard system for trials in medical devices
The already lengthy product registration process will be further set back by potential staff cuts to the already small number of medical device reviewers (28.) Restrictions prohibit hiring individuals who have worked in the medical device industry in the past five years.
Back in April, the U.S. International Trade Commission (ITC) issued a press release announcing the launch of a fact-finding investigation into the competitive conditions affecting U.S. trade of medical devices and equipment in principal foreign markets, particularly the Japanese market.
As a follow-on to this article, Pacific Bridge Medical plans to publish an additional article on the regulatory environment in other Asian countries, including South Korea, Singapore and India.
