The key stakeholders who are involved in drug approvals in China are: Drug manufacturers Distributors Central government: various agencies Provincial government: various agencies Hospitals: various classes and levels KOLs and physicians For more information about the regulatory framework in China, please see Pharmaceutical and... Read More
For Class B, C, and D medical devices (see Classification of General Medical Devices in Singapore), there are two submission routes in Singapore: the abridged submission route and the full evaluation route. The abridged submission route is only for medical devices that... Read More
For more information about Singapore’s regulatory framework, please see Singapore 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 (www.pacificbridgemedical.com) and, if possible, a... Read More
In August 2014, the Association of Southeast Asian Nations (ASEAN) -- which includes Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, the Philippines, Singapore, Thailand and Vietnam -- signed the ASEAN Medical Device Directive (AMDD). The AMDD creates a harmonized regulatory model for ASEAN... Read More
There are many new changes in the Japanese medical device regulations. Read More
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
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
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
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