The Food and Administration of the Philippines (PFDA) is undergoing radical restructuring to improve its services starting in 2013. As a result, the PFDA stopped receiving applications for the procedures listed below on December 1, 2012, and it is expected to resume... Read More
Starting next year, Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) will increase its capacity to provide medical companies with face-to-face regulatory strategy consulting. As of September 2012, the PMDA has handled about 50 face-to-face pre-consultation sessions per year, and it intends to... Read More
ASEAN (Association of Southeast Asian Nations) recently released a draft of the ASEAN Medical Device Directive (AMDD) for comments in August 2012. This draft aims to enhance and harmonize medical device regulations among member countries. ASEAN plans to implement the Directive by... Read More
The Association of Southeast Asian Nations (ASEAN) is set to introduce the ASEAN Medical Devices Directive (AMDD), a uniform set of regulations that will cover all 10 of its member states. The AMDD will be written based on the Global Harmonization Task... Read More
India’s Ministry of Health (MOH) has renewed its effort to bring a long-pending bill on medical devices to Parliament. The Ministry recently met with the Federation of Indian Chambers of Commerce and Industry (FICCI), the Association of Indian Manufacturers of Medical Devices... Read More
Korea’s Food and Drug Administration (KFDA) and Indonesia’s National Agency of Drug and Food Control (NADFC) recently signed a memorandum of understanding (MOU) on safety and quality standards. This is the first inter-country MOU signed by the Indonesian NADFC. Prior to this... Read More
On May 1, 2012, the Taiwan FDA (TFDA) announced its plan to move towards Summary Technical Documentation (STED). This move is to align with GHTF SG1-N11:2008, Summary of Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of... Read More
Recently, the Malaysian government has been trying to implement stricter regulatory control of imported pharmaceutical products. Beginning July 2012, all drugs imported into Malaysia will be required to undergo a strict licensing scheme before entering the country. Companies who wish to import... Read More
Singapore’s Health Sciences Authority (HSA) and Malaysia’s National Pharmaceutical Control Bureau (NPCB), the pharmaceutical regulatory body within the Malay Ministry of Health (MOH) recently signed a memorandum of understanding (MOU) on pharmaceutical regulatory matters. This is the first health sector MOU signed... Read More
Like many other Asian countries, Hong Kong is developing a more regulated, harmonized system for medical device manufacturers and importers. Though registration is currently voluntary, manufacturers will soon be required to register their products. Get a head start by viewing our webcast... Read More