Medical watchdog seeks ways to control new market

PUBLISHED : Sunday, 04 June, 2006, 12:00am
UPDATED : Sunday, 04 June, 2006, 12:00am

The mainland's medical watchdog held two days of confidential meetings last week to find ways to tighten its grip on the rapidly expanding, scandal-plagued medical devices market.

More than 40 officials from branches of the State Food and Drug Administration met in Beijing on Thursday and Friday to discuss plans for a radical revision to existing legislation covering the agency's responsibilities.

Representatives from big international medical-device manufacturers, including Siemens, Johnson & Johnson and Shenzhen Mindray, took part in the meetings.

Before the administration was set up in 1998, responsibility for overseeing drugs and medical devices was shared between several government departments.

The State Council defined the administration's role in law in 2000 but, as China has grown as a consumer and manufacturer of medical products, gaping holes have emerged in how the watchdog should monitor and remedy problems in production, distribution and licensing of medical devices.

The watchdog plans to draft new rules redefining its role and the meaning of 'medical device'. It also plans to streamline registration of manufacturers and their products, and consult industry and the government on the proposed changes.

At the meetings, officials proposed simplifying procedures for approving licences, focusing on safety rather than market development, cutting red tape to reduce opportunities for official corruption, and specifying criteria for quality reviews and tests.

The meetings come after the administration issued a public notice on April 30 calling for an immediate halt to the production, sale and use of hydrophilic polyacrylamide gel - more commonly known as PAAG - which had been used in cosmetic procedures on more than 300,000 mainland women.

In mid-April, it was reported that at least six Hong Kong women lost one or both breasts after having them injected with PAAG. Dozens more sought medical help following severe bruising, swelling and pain after the treatment, mostly in unlicensed clinics or beauty centres on the mainland.

Last month, a drug used for liver, gall bladder and gastric ailments - armillarisin A - was found to have been produced using a fake ingredient, diglycol, by Qiqihar No 2 Pharmaceutical company. At least 10 people have died so far.

Shenzhen Food and Drug Administration official Yuan Binhua said: 'Currently, each province's food and drug administration branch has the right to authorise licences for new medical devices. The different standards and tedious procedures have raised licensing costs and generated complaints from business.'

Liu Pei , deputy director of the watchdog's Department of Policy and Regulation, said State Council approval for an overhaul of the administration's rules would take two years, but action could be taken in the shorter term.