China regulations for medical registration could be easing soon. On October 8, 2017, new regulations from the State Council were issued. The proposed changes are not yet law. For both drugs and devices, the proposed changes will include: Acceleration of the CFDA... Read More
The Indian government is increasing its efforts to target the overpricing of medical devices in the country. On August 1st, the Indian government informed parliament that medical devices must have the maximum retail price (MRP) labelled on their packaging by 2018. Minister... Read More
The Malaysian Medical Device Authority (MDA) has updated the requirements for medical devices that are exempt from registration. The devices are the following: Demonstration models for marketing or education Models built for clinical research or performance evaluations Custom-made or special access devices... Read More
The Taiwan Food and Drug Administration (TFDA) has completed a draft of the new Medical Devices Act. The new act will effectively separate the management of medical devices from the existing Pharmaceutical Affairs Act. The draft proposal of the Medical Devices Act... Read More
This article was originally published on MedTech Intelligence. Approximately the third largest in the world, China’s medical device market is currently worth about $21 billion. However, given the country’s large geographic area, fragmented markets and thousands of medical device distributors, the search... Read More
Following the example of the U.S. FDA's Orphan Drug Act established in 1983, some Asian countries have developed orphan drug legislation, such as Singapore's Orphan Drug Exemption to the Medicines Act and Japan's Orphan Drug Amendment to the Pharmaceutical Affairs Law. While... Read More
Malaysia’s Medical Device Authority issued new mandatory medical device adverse event reporting criteria. If a medical device fails, is found to be not as effective as it claims, or has inadequate labelling or instructions, a report must be submitted within 30 days... Read More
Introduction Laos was a French colony until 1953 and then underwent a civil war. Laos achieved political stability in 1975 when the war ended. Then, beginning in the late 1980s, Laos’ communist government started market reforms and opening up to the world.... Read More
Taiwan is a developed island economy on the East China Sea with a population of 23.4 million. According to the IMF, Taiwan’s economy grew at 2.2% in 2016, and its PPP adjusted GDP per capita is $48,000, compared to $41,300 in Japan... Read More
Introduction Japan has some of the highest healthcare standards in the world, with the Japanese government providing health insurance for approximately 99% of its citizens. After the United States, Japan was the second country to establish regulations for the development of orphan... Read More