A third-party certification system for low-risk medical equipment will be introduced through Japan’s Pharmaceutical Affairs Law (PAL) revisions within the next two years. Products designated by the Ministry of Health, Labor and Welfare (MHLW) as medical equipment requiring controls, or Designated Medical... Read More
In a move to raise competitiveness in the pharmaceutical industry in China, the State Food and Drug Administration (SFDA), the government body which has replaced the State Drug Administration for some pharmaceutical regulatory functions in China, has lifted price controls on over... Read More
The Pharmaceutical Affairs Law (PAL) that passed legislation in Japan last year included four major revisions that are noteworthy to foreign medical device manufacturers: Revision of the measures for safety related to medical devices, Enhancement of the measures for safety after marketing,... Read More
In response to the recent price fluctuations of medical products in China due to the SARS (Severe Acute Respiratory Syndrome) outbreak, the Chinese government released a circular in April 2003 announcing that measures will be taken to prevent price gouging on medical... Read More
The Ministry of Public Health in Thailand announced in late 2002 that it is drafting a new Medical Device Act. The new act will include revised registration requirements as well as regulations on product liability. The act will also outline the licensing... Read More
This article covers some of the changing dynamics of the regulatory scene in Asia for pharmaceuticals and medical devices, with information and updates from China, Korea, Japan and Taiwan. Drug prices and reimbursement rates have been cut as governments take steps to... Read More
In January 2003, the Shanghai Drug Administration Bureau announced its resolve to tighten controls over pharmaceuticals and drug distribution as well as create more efficient systems for reporting adverse reactions to medication. According to recent reports by the bureau, of 14,980 drugs... Read More
SPRING Singapore (Standards, Productivity and Innovation Board) and the Economic Development board launched Singapore’s first efforts to standardize the country’s medical devices industry on January 17, 2003. The standard proposed by the governing authorities is called the Technical Reference for Medical Device... Read More
The Japanese Ministry of Health, Labor and Welfare (MHLW) recently announced the establishment of a new Good Laboratory Practice (GLP) regulation for medical device testing in Japan. The new GLP will take effect on October 1, 2003 and will regulate pre-clinical trial... Read More
Certification is often required in many countries for designated products such as electronics and medical devices. Regulated products cannot be sold without certification marks if they have been designated as “compulsory certification products.” Product certification marks are used to inform consumers of... Read More