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Medical Devices in China: Regulatory Overview

Medical devices were not required to be formally registered for sale in China until late 1994. Since then, however, several regulations with regard to the import and sale of medical devices have been implemented. The State Drug Administration (SDA) is the central... Read More

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Asia: Medical Device Regulatory Issues

Regulations for medical devices vary by country in Asia and are always changing. India and Malaysia, which previously did not have regulations for product registration, have recently adopted stricter and more comprehensive guidelines. In Taiwan, where registration rules were different for domestic... Read More

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Entering China’s Medical Marketplace

Once severely restrictive in practice and economically limited, markets in China are beginning to hold brighter prospects for successful entry by foreign manufacturers and suppliers. Medical product companies looking for product import, distribution and manufacturing opportunities in China will find promise in... Read More

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Importing Drugs Into China: An Update

China's pharmaceutical market is the second largest in Asia, worth $22.5 billion, and will likely increase upon China's entrance into the WTO. In March 1998, the Chinese government created the State Drug Administration (SDA) to oversee drug importation, improving the enforcement and... Read More

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China Medical Device Market 2000

China's medical device market is one of the largest in the world, and with China's accession to the WTO, foreign medical companies have an even greater opportunity to enter this fast-expanding market. As people in China continue to demand better healthcare, the... Read More

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China Pharmaceutical Update

China's pharmaceutical market is booming, and with the formation of the State Drug Administration (SDA) in 1998, enforcement of pharmaceutical regulations has greatly improved. An increase in drug supervision, through stricter punishments for drug research, declaration and registration violations, was implemented by... Read More