Globally, there has been a trend toward using more real-world data in the development of drugs and devices. Japan’s MHLW is also taking note and has drafted 2 new guidelines – 1. A basic policy on using registry data in registration submissions... Read More
Five years after Taiwan first urged medical device manufacturers to include unique identification (UDI) codes on the labels of their products, regulators are seeking public consultation on making the voluntary labeling protocols mandatory. The draft requirements would mandate UDI labels include a... Read More
Following the lead of the United States, the European Union, China and other countries, Singapore is establishing a Unique Device Identification system for medical devices. The system is scheduled to be required first on high-risk implantable devices beginning in 2022, and on... Read More
Medical devices may not be promoted or advertised to healthcare professionals or institutions in Thailand without permission from appropriate regulatory authorities, according to a directive issued in November by the country’s Food and Drug Authority. The guidelines on direct advertising were among... Read More
In response to growing concern that pharmaceuticals imported to China do not always adhere to the same safety guidelines they follow when marketed abroad, Chinese health authorities in October put forward a proposal to update domestic regulations governing drug recalls. The proposed... Read More
Moving to better ensure the safety and efficacy of medical devices offered for sale in Thailand, the country’s Food and Drug Administration (FDA) in October issued a list of technical specifications for devices that must be presented to authorities on request. Under... Read More
Introduction to China’s Drug Market Everyone has been talking about opportunities in China’s drug market the last 5 years. While the size of the drug market in China varies, we estimate it at about $140 billion dollars now and growing about 10%... Read More
Medical device manufacturers seeking to market their products in China will be required to adhere to new guidelines in the risk assessments they submit to authorities, the National Medical Products Administration (NMPA) announced in August. The periodic risk assessment reports, which outline... Read More
Moving to further strengthen the safety management of medical devices that are implanted into the human body, the Ministry of Food and Drug Safety is instituting a new tracking system called – “Implanted Medical Device Safety Information Check System” – which will go into... Read More
Medical device manufacturers marketing their products in Malaysia will be required to report to government authorities any events related to their use that could negatively impact patient’s health, under a Medical Device Authority regulation that went into effect on July 1. The... Read More