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
On December 17, 2013, the China Food and Drug Administration (CFDA) announced a streamlined device registration renewal process that took effect on January 1. The updated process will reduce the burden of paperwork on manufacturers, result in faster renewal certification approvals and... Read More
Foreign manufacturers with no local presence in Japan must appoint a Marketing Authorization Holder (MAH) or a designated MAH (dMAH) to manage their device registrations and liaise with the Pharmaceuticals and Medical Devices Agency (PMDA). Both MAH and dMAH must be based... Read More
Healthcare corruption in China was a big news item in 2013, with investigations conducted into milk powder firms as well as both domestic and international drug companies, such as GlaxoSmithKline (GSK). Chinese authorities have vowed to increase food product safety checks and... 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
As China's Food and Drug Administration (CFDA) undergoes reorganization, it is placing more emphasis on post-market compliance for medical devices. This includes changes to processes such as Adverse Events (AE) reporting and the re-registration of medical devices. Both of these processes will... 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