Following the implementation of the New Pharmaceutical Affairs Law (PAL) in Japan on April 1, 2005, foreign companies registering and marketing their products in Japan should be aware of the new regulatory changes that have taken place. These changes include the new... Read More
The Thai Food and Drug Administration (FDA), under the Ministry of Public Health (MOPH), is responsible for protecting the health of consumers by ensuring the safety, quality and efficacy of health products, including food, pharmaceuticals, medical devices and cosmetics, in Thailand. The... Read More
To expand their sales in the Asian medical markets, medical companies need to stay abreast of the new and changing regulatory environments for drugs, devices and In Vitro Diagnostics (IVDs). New or improved regulations are implemented frequently in Asia, including changes in... Read More
Despite the country's small size, Singapore boasts a highly-developed economy and serves as an Asian hub for numerous medical companies. In total, Singapore's medical device and pharmaceutical markets are estimated at over $800 million. Leading pharmaceutical companies, such as GlaxoSmithKline, Pfizer, Eli... Read More
Taiwan's medical device market is one of the most advanced in Asia and it continues to be increasingly sophisticated. The market is worth nearly $900 million, making it Asia's 4th largest. Taiwan's domestic industry is growing, but it remains largely fragmented and... Read More
In April 2004, Taiwan’s Department of Health (DOH) published a new draft that will alter the classification and registration system for medical devices in Taiwan. The regulation will be formally announced in late 2004, once the DOH receives feedback from the medical... Read More
A Ministry of Health, Labor and Welfare (MHLW) panel has recommended reclassifying 350 drugs and allowing them to be sold as over the counter (OTC) medications at convenience stores. Types of drugs include intestinal remedies, gargles, antiseptics, vitamin-based remedies and cough rubs.... Read More
In July 2003, Hong Kong’s Department of Health (DH) and the Electrical and Mechanical Services Department (EMSD) together released a consultation document entitled “Regulation of Medical Devices in Hong Kong.” Currently, Hong Kong does not have any specific legislation that regulates the... Read More
The Asian medical market is facing rapid changes as modernization greatly enhances the development of new and improved medical devices. Japan's recently revised Pharmaceutical Affairs Law (PAL) has maintained its basic purpose since 1948: to guarantee safety, efficiency and quality of medical... Read More
One of the main revisions of the Japanese Pharmaceutical Affairs Law (PAL) that was passed in 2002 will be the re-categorization of medical devices. The Japanese medical devices classification system will be revised in the PAL to take into account the risks... Read More