The ten nations that make up the Association of Southeast Asian Nations (ASEAN) -- Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, the Philippines, Singapore, Thailand and Vietnam -- together have a population of over 610 million, almost twice the population of the U.S.... Read More
Over the course of 2013, India's healthcare sector took several steps to strengthen drug and clinical trial regulations, re-established the elected Medical Council of India, and made progress in the Health Ministry's work to develop alternative and cheaper technologies like an indigenous... Read More
Japan is the second largest medical device market in the world. Getting through the registration process and selling your product on the market is not an easy task. This webcast will focus on key steps including PMDA consultation sessions, how to maximize... Read More
Indonesia, a country of more than 6,000 inhabited islands, has a population of over 250 million people -- the fourth most populous country in the world. Indonesia's GDP grew slightly less than 6% in 2013, and is forecast to grow between 5-6%... Read More
The Philippines, a Southeast Asian country made up of more than 7,000 islands, has a population of over 100 million people -- making it the 12th most populous country. 2013 Philippine GDP growth was among the fastest in Asia, at almost 7%.... Read More
Indonesia has introduced updates to its electronic registration platform for medical devices, in preparation for its integration with the regulatory system of the Association of Southeast Asian Nations (ASEAN) in January 2015. It has also clarified rules for customs integration and declaring... Read More
印度尼西亚引入医疗器械电子注册系统，此举是为其于2015年1月融入东南亚国家联盟（ASEAN）法规体系做准备。同时对于医疗器械及相关附件的海关申报也出台了明确规定。 Read More
By July 2014, almost all medical devices sold in Malaysia will require registration. In addition, all legal representatives of foreign medical device companies must have establishment licenses and certificates for Good Distribution Practices (GDPMD). Under the Medical Device Act 2012, those who... Read More
Japanese legislators will soon make major changes to Japan’s Pharmaceutical Affairs Law (PAL), which has governed all drugs and medical devices sold in Japan since 1960. Under two separate bills being considered by the diet, cellular and gene therapy products will have... Read More
On August 30, 2013, India’s Ministry of Health proposed legislation that would — for the first time in the country’s history — require the comprehensive regulation of all medical devices manufactured in or sold in India. The Drugs and Cosmetics (Amendment) Bill... Read More