Seeking to stem confusion among drug and medical device manufacturers, China’s regulatory authorities in July released a draft set of rules clarifying how to register products combining both medical devices and pharmaceuticals in the country. The draft Guidelines for the Registration Review... Read More
For the first time, regulators in Japan are carrying out surprise inspections at facilities where pharmaceutical and medical device products are manufactured. The inspections, which began in August, are designed to improve Japan’s system for ensuring the products are consistently produced according... Read More
Signs are emerging that China will tighten its policies governing clinical trials of drugs produced in the country, part of a series of moves to bolster the study of the safety and effectiveness of pharmaceuticals and to bring them fully in line... Read More
Two months after Korea announced a new system that puts private review boards in charge of ensuring that advertisements for medical devices adhere to government standards, the scope of the reviews and details of the application process is beginning to become clear.... Read More
Government-run hospitals in Indonesia are required to buy locally-produced medical devices covering a broad range of product categories as part of a new government regulation that went into effect on June 18. The new mandate, designed to promote domestic products, is... Read More
With the use of standalone software as a medical device (SaMD) rising rapidly in Singapore, the country’s health authorities in July unveiled a draft roadmap of regulatory guidelines on software or mobile apps which have a medical purpose and invited public consultation... Read More
Seeking to topple long-standing obstacles to drug innovation in Japan, pharmaceutical industry leaders in the country have outlined a slate of steps they propose the government take to foster research and development of new products, trim regulations and approval times, and speed... Read More
Philippines authorities are considering setting price caps on a broad array of innovative drug products marketed in the country for the treatment of cancer, diabetes, and cardiovascular disease. Prices of the pharmaceuticals, sold mainly by foreign manufacturers, have been rising rapidly over... Read More
Background information The original Japanese Device MF system was established in December 2000. This system is called the “Old MF system”. At that time, the applicable raw materials were limited to Polyvinylchloride, Polyethylene, and Polypropylene. The current Device MF system was established... Read More
Eight months after Singapore first announced its plans to establish a Unique Device Identification (UDI) system for medical devices, the country’s health regulatory authority has released draft guidance on how the system will work. According to the guidance, when the system is... Read More