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
China’s National Medical Products Administration (NMPA) in May published adjustments to its guidelines for clinical trials of medical devices. The changes affect the process of gaining approval for clinical trials of new devices under new requirements, instituted early this year, which mandate... Read More
A growing number of Chinese cities are joining its successful bulk drug purchasing program, which has put pressure on pharmaceutical firms to cut prices since it first went into effect last year. That is likely to decrease market share for individual firms,... Read More
Continuing its efforts to encourage innovation in the medical device market while raising standards, China is considering revoking its requirement that medical devices be tested only in testing centers certified by the National Medical Products Administration (NMPA). But it is uncertain whether... Read More