China’s Center for Medical Device Evaluation (CMDE) has issued a new draft guidance for obtaining approval of 3D-printed medical devices, as the nation’s regulatory authorities focus new attention on the fast-developing field of 3D printing technology. The guidance, proposed by the agency... Read More
Under Japan’s Pharmaceuticals and Medical Devices Act (PMD Act), foreign companies that intend to manufacture drugs, quasi-drugs, active pharmaceutical ingredients (APIs) or medical devices overseas and import them into Japan must be registered with the Ministry of Health, Labor and Welfare (MHLW).... Read More
Starting from April 1, 2018, Japan increased its registration fees for medical devices. Japan’s Pharmaceutical and Medical Device Agency (PMDA) announced fee increases of 8 to 15 percent for Class II, III, and IV devices. Under the new structure, a new Class... Read More
New bills aimed at promoting the use of medical devices have been introduced in Korea’s National Assembly. The government is aiming to boost the devices industry as it pursues broader reforms to expand national healthcare coverage to include all previously non-reimbursed services... Read More
China’s Center for Drug Evaluation (CDE) completed 9,680 drug filings in 2017, slashing the backlog of filings to 4,000 from a high of 22,000 in September 2015. A total of 394 market approvals were issued during the year, made up of 278... Read More
This article was originally published on MedTech Intelligence. Last year, Research and Markets released a report projecting that China’s in vitro diagnostics (IVD) market is likely to triple in size before 2022. This growth is driven by an aging population, a growing... Read More
In March 2018, China’s National People’s Congress approved plans for the China Food and Drug Administration (CFDA) to be merged into a newly formed National Market Supervision Administration, part of an overhaul of ministries. A new State Drug Administration under the merged... Read More
Japan is emerging as a world leader in the development of regenerative medicine, which refers to therapy products that replace or restore cells and tissues lost to disease or aging. A series of reforms have helped sparked a “regen” boom in the... Read More
On February 6, 2018, China’s Food and Drug Administration (CFDA) and the Center for Medical Device Evaluation (CMDE) issued a new draft guidance for the approval of medical devices intended to treat rare diseases. The guidelines set out requirements for applicants to... Read More
Over the last few years, the number of clinical trials in India has dropped by 90%. In March 2018, India’s Health Ministry released a comprehensive set of rules for clinical trials that will apply to all new drugs. The rules, covering everything... Read More