On February 12, 2007, the Singapore Parliament passed the Health Products Act 2007 into law. This represents a major change to Singapore’s regulatory system, bringing a number of medical products under mandatory regulation, starting with medical devices. Previously, medical devices were registered... Read More
The Taiwanese legislature passed the “Biotech and New Pharmaceutical Development Act” in June 2007. The Act is designed to offer incentives to companies in the pharmaceutical and biotech industry. In one major change, the Act allows publicly-funded researchers to help private companies... Read More
Japan's long recession is over. After a frustrating period of starts, stops, and even reverses in economic growth (1990-2002), Japan's GDP growth has stayed near or above 2% since 2003. With its affluent and aging population, Japan is the second-largest medical market... Read More
Malaysia’s Ministry of Health (MOH) has been working for several years on gradually establishing a medical device registration system. In February 2005, they announced the Medical Device Voluntary Establishment Registration program, abbreviated MeDVER. Implemented in January 2006, this is a system where... Read More
China’s State Food and Drug Administration (SFDA) has recently issued various laws to regulate more stringently quality control in the medical market. The US Department of Health and Human Services (HHS) is also helping China improve its medical market. The HHS and... Read More
The Central Government in India has recently drafted legislation to ensure quality control of vital life-saving medical devices such as endoscopes and pacemakers. Drafted by the Sree Chitra Tirunal Institute for Medical Sciences and Technology, the draft has been forwarded to the... Read More
The Medical Device Product Working Group of the ASEAN Consultative Committee for Standards and Quality held a meeting from July 30 to August 2, 2007 to discus various topics and strategies to increase harmonization of medical device regulations across the ASEAN countries.... Read More
The U.S.-Japan Regulatory Reform and Competition Policy Initiative issued its sixth report this June. The report outlined various recommendations to facilitate economic growth and increased trade between the two countries, including plans for the medical device and pharmaceutical market. Most of the... Read More
Taiwan’s Department of Health (DOH) plans to introduce a Health Technology Assessment (HTA) system to control rising healthcare costs. This HTA system would require all medical devices, new drugs and innovative surgical procedures to demonstrate effectiveness in improving patients’ health and cutting... Read More
The Philippines’ Department of Health (DOH) has recently issued Administrative Order No. 2007-003 which transfers some medical device regulation responsibilities from the Bureau of Food and Drugs (BFAD) to the Bureau of Health Devices and Technology (BHDT). Joint Bureau Memorandum No. 2007-1... Read More