Even as a fascination with new medical technologies powered by artificial intelligence (AI) increasingly takes hold in China, the country’s regulatory framework to manage this growth is still slowly evolving. Some Chinese hospitals are using robots to perform surgeries. Medical providers employ... Read More
Pushing to strengthen its supervision of drugs and medical devices across its vast market, China’s National Medical Products Administration in May launched a pilot data-sharing platform to track product information digitally across 17 provinces. If successful, the system will be fully operational across... Read More
Recently, China’s National Medical Products Administration moved to implement regulations on the development, production, and use of custom 3-D printed medical devices, as the new products rapidly grow in usefulness and popularity. The regulations – the first in China on custom medical... Read More
As medical devices increasingly flood the Malaysian market, authorities are instituting new regulations that put responsibility for ensuring the safety and efficacy of the products squarely in the hands of manufacturers. The regulations make manufacturers accountable for handling complaints, responding to incidents... Read More
China has approved stricter controls on the management of human genetic resources. The new requirements, which took effect July 1, follow the international outcry over the handling of genetic materials in China. They mandate that genetic materials are used strictly for scientific... Read More
The Thai Food and Drug Administration (FDA) in June issued a series of amendments to its Medical Devices Act, which regulates the use and sale of medical devices in the country. Among the 16 new clauses enacted in June are prohibitions on... Read More
Starting this month, medical device manufacturers will be required to use an internationally standardized electronic system to submit their products for approval in China. China’s National Medical Products Administration (NMPA) began implementing the Electronic Regulated Product Submission system (E-RPS) on June 24.... Read More
Moving forward with efforts to expand the options for testing of medical devices offered for sale in China, the government is soliciting opinions on a proposal to permit the testing of medical devices in testing centers not certified by the National Medical... Read More
Data released by China’s National Medical Products Administration (NMPA) on May 31 showed a steep decline in the registration of new medical devices in 2018. The 25 percent decline between December 2017 and December 2018 sunk the overall medical device registration numbers... Read More
South Korea’s Ministry of Food and Drug Safety is instituting new quality standards on the testing, marketing and use of medical devices that are more in line with established international norms. The new standards will go into effect in phases beginning July... Read More