As the demand for quality healthcare in East Asian countries skyrockets, so does the potential for astronomical growth for the pharmaceutical and medical device industries. While jumping into markets in that region can be tempting, it is important to note that registering an innovative product can be a convoluted process in new, and oftentimes under-regulated, healthcare markets. Predicate devices can be hard to come by, which makes for uncertainty regarding the specific approval process for many products. Additionally, new and evolving regulations can make relevant protocols and requirements hard to identify. RegDesk product allows you to see and always be updated with today’s combination device regulations.
It is in this context that RegDesk’s value proposition is most clear. Using a single data point to gain the most current information on the regulations and registration processes of developing markets puts time, money, and product approval at risk. Crowdsourcing the regulatory knowledge of on-demand, in-country experts eliminates these risks by delivering reliable information to RegDesk’s clients.
A large medical device manufacturer sought registration for their FDA and EMA approved oncological combination device in China, India, Korea, and Taiwan. To reach its ultimate goal of multinational approval, the company needed to develop a regulatory strategy by which the classification of its product as a combination device could be preserved, country-specific clinical trials could be avoided, and the approval process could be expedited. The company enlisted the help of RegDesk to receive reliable answers to the pressing questions that created holes in their strategy.
Combination devices regulations, especially those intended for cancer treatment, are not particularly common in the Chinese, Indian, Korean, and Taiwanese markets. Because there is a very limited number of these types of devices in these countries, the typical approval pathway for combination devices is generally unknown. In the U.S., our client’s device was classified as two separate entities by the FDA: as a drug and as a device. For the newly targeted region, finding out whether or not each country’s regulator had the mechanisms in place to view the product as a single combination device was crucial to the product’s registration. Once the confusion over the classification issue was resolved, a regulatory strategy that minimized complexity, time, and costs needed to be established.
Here are the main questions RegDesk needed to answer:
Would the drug and medical device components of the product be seen as intrinsically intertwined?
What departments would oversee the registration of the product?
Could data from the U.S. and the E.U. clinical trials be used to avoid local clinical trials?
RegDesk assembled a flash team of experts with extensive knowledge on the registration of a range of pharmaceuticals, medical devices, and combination devices. The average number of years of experience of the team of consultants was:
26 years in India
25 years in China
15 years in Korea
11 years in Taiwan
The team provided the most current intelligence on the nature of existing combination device regulations in the target markets, the similarities and differences between those devices and the client’s device, the validity of U.S. and E.U. clinical data in the local registration processes, the costs and timelines associated with these processes, and several market-entry strategies that our client could implement.
“There is the potential to save quite a bit of time by having one centralized source to go to. As a result, there is a convenience, a simplicity factor involved [when working with RegDesk].”
-Vice President of Global Regulatory Affairs
The final, comprehensive report RegDesk presented to the client clearly laid out the classification the combination device would be afforded by each country’s regulatory agency and identified the departments that would oversee the registration of the product. A list of the required documents for each application and the time and costs associated with it was also included in the report.
RegDesk’s product, complete with thorough and actionable market-entry strategies, provided the client with tremendous value and clear steps for how to penetrate the four target markets with its innovative device.