The Medical Device Control Office (MDCO), part of Hong Kong’s Department of Health, recently made official the Conformity Assessment Framework. This is a framework for new conformity assessment requirements for medical devices and information on Conformity Assessment Bodies (CABs). Hong Kong currently... Read More
Almost all medical device purchasing in Japan is closely linked to the levels the national health insurance system will reimburse the devices at. In an effort to reduce healthcare spending, the government recently reduced the reimbursement prices of a majority of functional... Read More
In October 2005, the Indian Ministry of Health and Family Welfare issued notifications that essentially constitute the regulation of medical devices. The notifications amended the Drugs and Cosmetics Act of 1940 by reclassifying certain medical devices as drugs in order to bring... Read More
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