In an effort to expedite the device registration process, the Thai FDA has ended the pre-submission stage of the Thai application process. Previously, applicants for Thai medical device approval had to provide basic information about the product and wait for the TFDA’s... Read More
Malaysia’s MDA regulatory body, founded a decade ago, has concluded the public comments period for parties interested in submitting feedback on its new medical device guidance, MDA/GD/0009. Offering numerous examples, MDA/GD/0009 provides classifications of medical devices known as active, invasive and noninvasive,... Read More
A Chinese government program to buy pharmaceuticals and medical devices in bulk has been expanded to include a larger selection of devices, putting fierce competitive pressure on foreign medical device companies seeking to tap into the vast country’s market. First launched in 2018... Read More
Japan is way behind the US and EU for approving medical devices with AI. In September 2020, Japan introduced the IDATEN system (improvement design with approval for timely evaluation and notice) which was designed to quickly allow partial modifications of approvals for... Read More
Multinational pharmaceutical firms are taking advantage of fledgling low-cost commercial insurance initiatives in China to more readily access the country’s vast and rapidly growing market for their products—and to price them more competitively. Under strict eligibility rules on pharmaceuticals and medical... Read More
As part of Singapore’s ongoing efforts to guarantee the safety of medical devices that enter its markets, the country’s health regulatory authority has released draft guidance on labeling requirements for key categories of devices. The guidance builds on labeling regulations already in... Read More
Under draft rules released in January by the Philippines Food and Drug Administration (FDA), all in-vitro medical devices (IVDs) imported, marketed, or manufactured in the archipelago nation will soon for the first time be required to be registered with health authorities in... Read More
As part of an ongoing crackdown by China on business practices, it says lead to unfair competition, the central government is strengthening law enforcement of monopoly practices in the pharmaceutical industry. The announcement by the ministry of industry and information technology... Read More
In a much-awaited update, Malaysia’s Medical Device Authority (MDA) has launched a streamlined online registration system designed to make it simpler and more efficient for foreign manufacturers to register their medical device products to access the country’s market. The updates to... Read More
The government of South Korea is beginning to offer insurance reimbursement for the use of several ultra high-priced drugs, a development that could be both lucrative for pharmaceutical companies and provide relief to Korean consumers. Pharmaceutical treatments, under review by Korea’s Health... Read More