Telegraphing a desire to smooth the regulatory process for the growing ranks of software as a medical device (SaMD) product, a top Japanese regulatory agency official said the products will be evaluated as medical devices if they are designed to be used... Read More
Advertisements for medical devices are about to come under increased scrutiny in Singapore, with regulators of the wealthy island nation tightening restrictions to ensure the truthfulness of claims made in marketing the healthcare products. New guidance released in September by the city-state’s... Read More
With software-driven therapeutic interventions for patient treatments known as digital therapeutics (DTx) beginning to make a mark in the world of patient care, the government of South Korea is beginning to lay the groundwork for the entrance of the technologies into its... Read More
Regulations governing the use of Advanced Therapy Products (ATPs) went into force in Hong Kong in August, codifying an ordinance passed last year by the legislative council of the special administrative region of China that subjects the products to tighter regulation. The... Read More
Alarmed by increasing blockages in the supply chain of prescription drugs, the Japanese government is considering requiring manufacturers to alert the government to anticipated shortages of their products. Such a mandate, floated in recent interviews by health officials, would require passing legislation.... Read More
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 in Korea adhere to government standards, the scope of the reviews and details of the application process is beginning to... 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