Archives
CDx Registration in Korea, Taiwan, Singapore, Australia, and the Other Asian Markets
PBM can help you develop the best regulatory and reimbursement strategies in Asia. Please contact us to learn more. Many drug companies doing clinical studies and product registration in Asia are now looking to add Western CDx’s to make the use of... Read More
Japan CDx Registration
Pacific Bridge Medical has worked with a number of Western CDx companies to address the above issues and register CDx products in Japan. Please contact us to learn more. As medical care becomes more personalized, more drug companies are looking to utilize... Read More
China CDx Registration
Please contact us to learn about how we can help you register your CDx product in China. Using Western CDx products, drug companies and their specific drug products can more easily target the right patients with specific diseases. Unfortunately, CDx registration in... Read More
China Drug Master Files for API, Excipient, and Drug Packaging Material Manufacturers
Contact us to learn how we can help you with DMF registration in China. API, excipient, and drug packaging manufacturers that want to protect their intellectual property and manufacturing processes will want to do a China DMF. Manufacturers with EU CEP, US... Read More
Japan Takes Additional Steps to Expedite SaMD and AI Products
The Japanese government is considering a new program to shorten the approval review for software as a medical device (SaMD) and AI products. Currently, approval of these types of products can take several years in Japan. With the new regulations, approvals could... Read More
Singapore Updates Special Access Routes (SAR) for Unregistered Class D Devices
In January, Singapore’s MOH updated GN-26 and GN-27 SAR for non-registered medical devices. Doctors, medical institutions, and labs can now more easily import non-registered Class D devices that are new or have new indications, or are new implants. Certain categories of non-registered... Read More
Vietnam Extends Pharmaceutical Licenses
In early January, the Vietnamese government extended the validity of certain drug licenses. First, drugs and drug substances with market authorizations that expire this calendar year will be automatically extended until December 31, 2024. Second, drugs and drug substances with market authorizations... Read More
India Government Now Requires QR Codes for APIs
Starting January 1, 2023, the Indian government requires all Active Pharmaceutical Ingredients (APIs) manufactured in India to have QR codes. The reason for this government initiative is to help guarantee the quality and safety of APIs. Historically, about 20% of APIs made... Read More
China Lowers Import Tariffs on Device Imports
At the end of 2022, the Chinese government lowered import tariffs for several types of products including medical devices. This tariff reduction took place on January 1, 2023. Tariffs were reduced for about 14 different types of medical devices. Starting on July... Read More