India’s Central Drugs Standard Control Organization (CDSCO) is currently organizing efforts to transition from a paper to an electronic document management system. The CDSCO is responsible for the approval and issuance of licenses for various medical products, such as vaccines, IV fluids,... Read More
The Drug Controller General of India (DCGI) and the US FDA have recently held talks on regulating medical devices, monitoring adverse events, and increasing cooperation between the two nations. Though drug regulations have been in place in India for over 50 years,... Read More
India’s Department of Biotechnology recently drafted the National Biotechnology Regulatory Bill, with a corresponding regulatory authority. The NBRA will be an autonomous, independent body providing biosafety clearance of genetically modified products and processes. The draft proposes NBRA being responsible for regulation of... Read More
On June 24, 2008, Vietnam and the United States signed a memorandum of understanding (MOU) to enhance the safety of medical devices, drugs, food, and feed traded between the two nations. This MOU is a result of discussions between senior Vietnamese officials... Read More
The Asian Harmonization Working Party (AHWP) met in March 2008 in Malaysia. In addition to discussing updates of the AHWP Technical Committee (TC), members also discussed updates on the Global Harmonization Task Force (GHTF) during the 4th APEC funded seminar. The six... Read More
Medical devices in India are largely unregulated at this point. To address this issue, the Department of Science and Technology (DST) had proposed a Medical Devices Regulations Bill, while the Health Ministry had proposed a similar bill to establish a Central Drugs... Read More
ASEAN industry members assembled in the Philippines in January 2008 to announce committee members of the new ASEAN Medical Device Industry Association (AMDIA). AMDIA is focused on representing the common regulatory interest of the medical device industry in ASEAN. It will also... Read More
The Asian Harmonization Working Party (AHWP) has finalized two documents on the Safety Alert Dissemination System (SADS) on January 23, 2008. The main goals of SADS are the following: To define a structure for disseminating medical device safety alerts among AHWP members;... Read More
The Health Sciences Authority (HSA) of Singapore has recently issued various Guidance Document drafts on their website. As described in Volume 7, Issue No. 10, Singapore passed its Health Products Act in February 2007 to regulate all medical products, including medical devices.... Read More
Asia's growth over the last five years has been phenomenal. China saw at least 10% annual growth in GDP between 2003 and 2006, and India's GDP figures progressed from 7% to 9% over the same period. These countries' medical device markets are... Read More