How RegDesk helped a Medical Device Manufacturer Enter 4 New Markets with Ease while cutting down on time and Costs

A medical device manufacturer wanted to register their FDA and EMA-approved oncological combination device in China, India, Korea, and Taiwan. The company urgently needed to develop a regulatory strategy to preserve the classification of its product as a combination device, avoid country-specific clinical trials, and expedite the approval process.

The client hired B to help them achieve three objectives:

• Find out if the product’s drug and medical device components are viewed as inherently linked.
• Identify the departments responsible for product registration in each country.
• Determine if data from clinical trials conducted in the US and EU could be used to avoid local clinical trials.

The company enlisted RegDesk’s help to answer their pressing regulatory questions and to receive reliable information. RegDesk assembled a flash team of experts with extensive knowledge of registering pharmaceuticals, medical devices, and combination devices in the target countries.
RegDesk’s highly experienced team of consultants, with an average of 26 years of experience in India, 25 years in China, 15 years in Korea, and 11 years in Taiwan, provided the client with the following: 

• The most current intelligence on existing combination device regulations
• The similarities and differences between those devices and the client’s device, the validity of us and EU clinical data in the local registration processes
• The costs and timelines associated with these processes
• Several market-entry strategies that the client could implement

RegDesk presented a final report to the client, which:

• Laid out the classification of the combination device in each country
• Identified the departments that would oversee the registration of the product
• Included a list of the required documents for each application and its time and costs

RegDesk’s product, complete with thorough and actionable market-entry strategies, provided the client with tremendous value and clear steps to penetrate the four target markets with its innovative device. It also saved the client resources in time and costs by approaching a centralized entity with a clear plan of action and experts.