China’s National Medical Products Administration (NMPA) in December began publicly soliciting opinions on proposed revisions to 94 medical device industry standards. The revisions, part of a broad reworking of medical device industry standards in China over the past two years, are expected... Read More
In November 2018, Malaysia’s Medical Device Authority released the Third Edition of its Guidance Documents on Requirements for Medical Device Labeling. Major changes include: Medical devices for home use must be labeled in Bahasa Malaysia. Other types of medical devices shall be... Read More
Legal protections for pharmaceutical patents registered in South Korea made significant advances in 2018, with rulings by the courts and moves by the legislature to bolster intellectual property rights for foreign firms doing business in the country. In the most significant step... Read More
Seeking to stem widespread tobacco dependency in a country that is the largest producer and consumer in the world, Chinese cities are increasingly implementing strict new restrictions on smoking in public. This November, Xi’an, the capital of Shaanxi province in northwest China... Read More
South Korea’s primary regulatory body, the Ministry of Food and Drug Safety (MFDS) is drafting plans to better sync its quality control requirements for medical devices with international standards. In proposing to align Korea Good Manufacturing Practice (KGMP) quality system regulations to... Read More
Social media platforms including Facebook and Japanese competitor Line would be prohibited from airing advertisements for medical devices in Taiwan, under legislation introduced in October. As written, the legislation would require that medical devices be approved by Taiwanese government authorities before they... Read More
Moving to implement a program to speed the review and approval of dozens of drugs sold abroad but not yet approved in China, the China Food and Drug Administration (CFDA) has established special channels to approve clinically urgently listed new drugs. The... Read More
Moving to modernize its process for evaluating the safety of medical devices, Indonesia’s Ministry of Health is launching a digital signature system for medical device marketing authorization licenses. The implementation of the digital signature system is designed to expand privacy protection and... Read More
The Philippines Department of Health is now requiring that most medical devices imported, marketed or manufactured in the archipelago nation be registered with its Food and Drug Administration. The new rules, first telegraphed back in January, are expected to increase costs for... Read More
China’s health insurance regulator in October added 17 anti-cancer drugs to the list of those already covered by its national medical insurance system. The approval of the therapies is part of a series of moves by the government to make cancer treatment... Read More