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.
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.
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.
Navigate complex regulatory terrain even when the map keeps changing.
Our team of regulatory experts leverages artificial intelligence technology to provide.
Become Our Next Success Story
From the smallest markets to major cities, RegASK experts have the nuanced expertise you need.
Our regulatory experts have extensive experience working with domestic authorities in developing countries and understand the processes involved in each market to ensure compliance and successful market entry throughout your product lifecycle.
Our experts leverage our technology to provide answers in a cost-efficient and swift manner, guiding you in making informed decisions and developing optimal regulatory strategies.