Moving to make pricing and technical information of medical devices more accessible, the Philippines in June announced it is creating a database of such devices considered necessary for use in all health facilities maintained by the government. The move by government authorities... Read More
Almost a year after Korea’s highest court ruled it unconstitutional for the government to require preliminary approval of advertisements for medical devices, the Ministry of Food and Drug Safety (MFDS) has announced that private review boards will review ads going forward and... Read More
Continuing to strengthen China’s oversight of the manufacture, import, and distribution of pharmaceuticals, the country’s health regulators in May published a series of measures medical institutions will be required to follow in prescribing and utilizing drugs to treat cancer. The measures released... Read More
In the latest move by India to ensure the quality and safety of medical devices produced in the country, government regulators are joining forces with leading medical device manufacturers associations to integrate industry quality management systems with regulatory requirements. The new framework... Read More
Even as it pushes to more tightly regulate its growing medical device market, Indonesia is making it easier to register some non-sterile risk medical devices that do not require special skills and are considered low-risk. Among the 34 devices that will be... Read More
With an estimated medical device market size of over 50 billion USD and growth rate of 10% per year, China has become an attractive market, full of opportunities, for foreign medical device companies. Foreign manufacturers of medical device components and raw materials... Read More
Currently the third largest medical device market in the world, Japan presents many opportunities for foreign medical device companies. However, only local companies with a Marketing Authorization Holder or Designated Marketing Authorization Holder (MAH/DMAH) license are legally allowed to import and market... Read More
Moving to rapidly put in place its new Unique Medical Device Identification (UDI) system to track medical devices, Chinese regulators have announced the second group of devices that will be required to employ the system. All Class 3 medical devices will be... Read More
A regulatory pathway that for the past six years has allowed Japan to accelerate the approval of innovative drugs and medical devices deemed to address urgent, unmet needs may be expanded to address the software as a medical device (SaMD) market. In... Read More
The new edition of the Japanese Pharmacopoeia, the official compendium of medicines approved by the government for use in the country, will include 33 new pharmaceuticals, among them antibiotics, excipients, and biologics, as well as many unrefined drugs. Inclusion in the Pharmacopoeia... Read More