Eighteen months after launching a pilot system to improve the tracking of medical devices, Chinese regulators are starting to build the system out, announcing the first group of products that will be required to employ the Unique Medical Device Identification (UDI) system.... Read More
Two years after Japan began employing a cost-effectiveness evaluation system to determine the efficiency and allocation of health resources, it is preparing for the first time to adjust prices of pharmaceuticals and medical devices based on such assessments. Japan’s Central Social Insurance... Read More
Seeking to clarify requirements manufacturers must follow when grouping medical devices together for the purpose of product registration, the Malaysian Medical Device Authority (MDA) in February released a new draft guidance document describing the applicable rules and procedures. According to the draft... Read More
For the first time in twelve years, Chinese regulators are drafting updates to government regulations on therapeutic and diagnostic products that combine drugs and medical devices. The draft updates released by the National Medical Products Administration (NMPA) include eight major changes designed... Read More
With the use of 3D-printed medical devices expanding rapidly in Singapore, government health authorities have released a set of guidelines for their regulation. Released in draft form in late January by Singapore’s Health Sciences Authority (HSA), the guidelines are designed to ensure... Read More
Three years after China launched a national drug bulk-buying program to negotiate lower prices from drug manufacturers, competitive pressure continues to grow on multinational pharmaceutical companies seeking to compete in the vast country’s market. The results of the fourth round of the... Read More
With the COVID-19 pandemic making it unsafe to conduct most on-site inspections, regulatory authorities in Malaysia are permitting remote assessments of some pharmaceutical manufacturing facilities outside the country. Malaysia’s Guidance Document on Foreign GMP Inspection, 7th edition, March 2021, published by Malaysia’s... Read More
Basic health insurance plans in China will begin this year to cover the cost of most drugs used to treat rare diseases, according to a National Healthcare Security Administration statement released in December. Under the plan, rare disease drugs that are proven... Read More
Tracking the safety and efficacy of implanted medical devices will be easier for patients and patient advocates in Korea, with the inauguration of a new government-run online information service designed to track and disseminate information about the devices. Foreign device manufacturers need... Read More
A decades-long push by Japan to spur innovation in its pharmaceutical industry is expected to get new life this year, with government health agencies planning to release by this summer a new set of goals for speeding clinical trials and encouraging the... Read More