New Japanese Regulations Go Into Effect on November 25, 2014
There are many new changes in the Japanese medical device regulations. Read More
Archives
China May Soon Issue a Revised Drug Administration Law
The China Food and Drug Administration (CFDA) has been working on a revision to the countrys Drug Administration Law. A draft version could be submitted to Chinas State Council by the end of 2014. Read More
Indonesia Healthcare Updates
Joko Widodo was inaugurated as the new President of Indonesia on October 20, 2014. One of the tough challenges Widodo’s administration will face is reforming the healthcare system. Indonesia has a complicated, decentralized healthcare system that spreads responsibility from the national level... Read More
2014 India Medical Device Updates Presentation
India is one of the fastest growing medical device markets in the world. This presentation offers an overview of important issues such as distributor search in India, medical device regulations, registration requirements, intellectual property, and more. To view these presentation slides,... Read More
Major Health Authorities in Hong Kong Infographic
For more information about the regulatory system in Hong Kong, please see Hong Kong Medical Device Regulations. You are welcome to use or share this infographic online or in your presentations and papers, as long as you include credits to Pacific Bridge Medical... Read More
Medical Device Classification in India Infographic
For more information about the regulation of medical devices in India, please see India Medical Device Regulations. You are welcome to use or share this infographic online or in your presentations and papers, as long as you include credits to Pacific Bridge Medical... Read More
India’s Central Drug Standards Control Organization (CDSCO) Infographic
For more information about the Indian medical device regulatory system, please see Medical Device Registration in India. You are welcome to use or share this infographic online or in your presentations and papers, as long as you include credits to Pacific Bridge Medical... Read More
China Medical Device Registration Renewal Infographic
For more information about the registration and regulation of medical devices in China, please see Medical Device Registration in China. You are welcome to use or share this infographic online or in your presentations and papers, as long as you include credits to... Read More
U.S. Food and Drug Administration: Medical Device Pilot Programs and the New Purple Book of Biosimilars
The U.S. Food and Drug Administration (FDA) has several pilot programs underway that should make many medical device applications simpler and faster. For premarket notifications, the 510(k) eSubmissions Program will guide companies in putting together and submitting a 510(k) application -- resulting... Read More