A Japanese manufacturer of support braces wanted to export its products to the E.U. market. They had a significant presence in Asia with a portfolio of over 30 SKUs but no presence in Europe.
They had some lingering concerns about the complexity of determining whether their products would be considered as Medical Devices or not by the European product classification. Although the European Commission regularly updates its manual on borderline medical devices with new products to assist MDMs in deciding whether theirs fall under the scope of a medical device (per Council Directive 93/42/EEC), they chose to get help from RegASK. They did this to be more confident in their portfolio’s compliance before market entry.
What’s The Problem?
The client needed to get an overview of relevant product classification and legislation governing their products
- To become familiar with the regulatory environment in other markets
- To avoid errors in interpreting existing regulation
- To determine the proper classification for their products
- To know if there were any registration requirements
- To review the compliance of their labels and on-pack marketing claims
- And to enter into the E.U. market to sell their products
What We Did…
RegASK proposed a fast-response solution by leveraging its augmented A.I., and
- Paired regulatory experts across the E.U. to identify the proper product classification for its entire portfolio
- Assessed the appropriate registration requirements to outline a path forward for successful market entry
- Included a review of label compliance and validity of on-pack marketing claims
- Provided a detailed report to help facilitate product registration and market entry
How Did It Do?
RegASK delivered a comprehensive regulatory overview in less than four weeks
The client could action all the necessary steps to complete product compliance and achieved a successful entry in the European market for its entire product portfolio of over 30 SKUs.
Conclusion
Our client needed to be supported in smart regulatory decision-making for its next commercial success. From Japan to Europe, it took us less than four weeks to give them all the product classification insight they required to identify what they needed to adapt – or not – in their products to enter the European market, which they successfully did.
RegASK is here to help you quickly find the proper regulatory insight for your products’ entry into any market around the world.
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