Originally Published MDDI June 2005
China's Regulations, Like Its Market, Becoming More Transparent
China's regulatory approval process has undergone a number of changes, many designed to make market entry simpler for industry, said U.S. and Chinese officials at a recent conference. However, it will be a while before the changes are fully implemented.
The Chinese use a standards-based system, and it is more stringent for implantables than for other kinds of devices. However, some speakers said the biggest obstacle to approval might not be the Chinese regulations themselves, but rather the lack of a communications infrastructure in China. It will be difficult for the government to communicate the new rules to industry. The Massachusetts Medical Device Industry Council sponsored the conference, which was held April 14 in Waltham, MA.
The first step for manufacturers is to declare what standard their product will perform to or exceed, said Chang Yongheng. Yongheng is director of the China State FDA (SFDA) Division of Product Registration. Manufacturers can choose a national, international, local, or product-specific standard. The last one, he said, may be easiest to prove. Manufacturers may not promote a device as being better than any others in its product class.
Then, he said, many Class II and Class III devices must be tested at an SFDA-certified lab. SFDA might consider waiving the requirement if the product already has approval elsewhere in the world, he noted.
Companies that have yet to market a product in China and want approval for an implantable device must conduct a trial in China, he said. For other cases that require data, presenting clinical results from another country is acceptable.
Before approval, Yongheng said, the Chinese government will inspect your manufacturing plant if you have a Class III device made anywhere in the world or a Class II device made in China. In some cases, an inspection cannot be arranged before the approval decision. Most of the time when that happens, SFDA will approve the product pending an inspection, allowing it to be marketed unless the firm fails the inspection. However, that option is not available if the product has not been approved elsewhere.
SFDA attempts to review an application within 90 working days and has made strides toward meeting that goal. However, four to six months is a more realistic time frame for U.S. firms to expect, said Jay Biggs of the U.S. Department of Commerce's Office of Health and Consumer Goods.
Some electronic medical devices must obtain a China Compulsory Certification, or CCC, mark. It certifies that the product is safe. Currently, seven types of devices are subject to the mark, but the list should expand in the future.
The U.S. Department of Commerce has been pushing for China to move from a laboratory testing–based system to a GMP-based system. China is beginning to institute GMPs, but it is likely to be several years before they are enforced, said Wang Lanming, deputy director general of SFDA's Department of Medical Devices.
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