Based on Ministerial Announcement No. 34 B.E. 2549 (2006), certain medical device importers in Thailand must submit, in addition to the required Certificate of Free Sale, proof of manufacturing quality of an imported product. Importers can submit either a GMP certificate or... Read More
This report helps medical device manufacturers and distributors better understand how to source from Asia. Topics covered include: how to identify manufacturers, how to perform due diligence, what to look for during factory visits, contract negotiations, regulatory requirements, logistics, quality control, 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 Chinese State Food and Drug Administration (SFDA) has recently issued a draft regulation “Measures on Managing Registration of Drugs,” which is currently soliciting public opinions on it. These measures outline new guidelines for evaluating drugs before marketing them in China. The... Read More
The Philippine Bureau of Food and Drugs has ordered all drug manufacturers, repackers and traders to submit a list of all the products they currently handle, including those still in the registration process. The Bureau is currently revising its documentation procedures and... Read More
Recently, Thailand has been focusing on upgrading its standards and promoting increased investment in its pharmaceutical industry. By 2008, the government has mandated that all manufacturing companies must update their quality systems to meet Good Manufacturing Practice standards based on the international... Read More
The Medical Device Control Office of Hong Kong (MDCO) has proposed listing local manufacturers of medical devices under the Medical Device Administrative Control System (MDACS). The main requirement to be listed will be for manufacturers to implement and maintain a quality management... Read More
The Government of India’s Union Cabinet has approved the establishment of the Central Drugs Authority of India. This Authority would be an autonomous organization under the Ministry of Health & Family Welfare. Currently, the Central Drug Standards Control Organization works with the... Read More
China's economy is growing rapidly, and so are standards of production. As its manufacturers continue to develop more sophisticated processes and products, quality standards are increasing dramatically. Medical devices are no exception. China's medical device market has grown to $6 billion, the... Read More
The Asian economy has experienced tremendous GDP growth over the past decade, and is expected to continue at a healthy pace for the next several years. In particular, the medical device market has been growing quite rapidly. More and more companies are... Read More