In mid-May, the Chinese NMPA issued a new IVD Reagent Classification Catalogue. The new catalogue has over 25 primary product varieties and over 1,800 secondary varieties. A number of specific reagent sub-categories are further defined including staining solutions, cell culture media, etc. IVD reagent... Read More
At several recent government meetings in China, there have been discussions on how to price innovative drugs. As of now, the NMPA defines an innovative chemical drug as a drug that has a new compound, increased clinical value, etc. This definition is... Read More
In late March, the Philippines FDA (PFDA) has extended the registration date for Class B,C and D medical device registration for devices that were not already on the registrable medical device list. Now, these medical devices do not need to be registered until... Read More
With over 1.4 billion people, India is currently the 3rd largest market in Asia after China and Japan. With geo-political tensions mounting between the US and China, more Western drug companies are thinking about manufacturing and sourcing drugs and drug components from... Read More
Japan has always been a good market for orphan drugs. The Japanese organizations that are involved in the process include the MHLW, PMDA and the National Institute of Biomedical Innovation (NIBIO). Orphan drugs must meet the following requirements – 1. less than... Read More
Malaysia, with close to 34 million people, is a good market for Western medical device exporters. The Malay Medical Device Authority (MDA), which falls under the Ministry of Health (MoH), registers devices. Malaysia, like the other ASEAN countries, has 4 classifications for... Read More
Korea Drug Reimbursement Update 2024 Korea is taking significant steps to improve the accessibility and affordability of innovative medications, with a particular focus on treatments for cancer and rare diseases. The government has recently implemented a series of reforms designed to streamline... Read More
In recent months, India has made significant strides in reshaping the regulatory framework of its medical device industry. These initiatives are designed to improve the Indian medical device market and contain healthcare costs. Updates to Medical Device Licensing Requirements The Medical Device... Read More
Recently, South Korea has been making significant progress in transforming its approach to healthcare, specifically through the integration of AI and digital technologies in medical devices. The Ministry of Food and Drug Safety (MFDS) is at the forefront of these efforts and... Read More