Medical Product Registration in Asia
Product registration in Asia can be a daunting task. Each Asian country has its own unique product registration requirements. How the medical product is classified can sometimes differ in each country. For example, a Class II medical device in the U.S./Europe may be a Class III medical device in Japan and require local clinical trials to get product approval.
Pharmaceutical/drug registration is also getting more regulated throughout Asia. Local drug clinical trials are becoming more prevalent in Korea and Taiwan to get product registration.
Another important question is who will hold your product registration in Asia. Should you register your medical products in your own name via your own local Asian office, an independent third party, or in the name of your local distributor?
Click on the countries below for more information on product registration in each Asian country and/or contact us to discuss your specific needs.