How RegDesk helped a Large Medical Device Manufacturer Secure Approval for their Medical Device in Japan with an Optimal Plan of Action

A large medical device manufacturer was seeking approval for antimicrobial central venous catheters and antimicrobial dressings in Japan. However, there seemed to be an inconsistency in the Pharmaceuticals and Medical Devices Agency’s (PMDA) clinical data requirements. The agency found some of our client’s competitors’ products’ clinical evaluations sufficient but required clinical data for others.

The company needed a clear understanding of which regulatory pathway to take for their products and whether clinical data would be required for approval.

RegDesk tapped into its vast international network of regulatory affairs consultants to provide thorough clarification on the blurred line between the Ninsho and Shonin routes. RegDesk gathered information from three vetted, Japan-based consultants in a single report for the client. It was revealed that the “inconsistency” in the PMDA’s regulatory framework is actually an intentional feature of its approval process. It allows the PMDA to exercise discretion when deciding which higher-risk medical devices require clinical evaluations and which require clinical data.

RegDesk’s report allowed the client to construct an optimal plan of action that secured approval for their medical device. In addition, the report revealed that the inconsistency in the PMDA’s regulatory framework was intentional, allowing the agency to exercise its discretion when deciding which higher-risk medical devices required clinical evaluations and which ones required clinical data. As a result, the client could schedule a consultation with Japan’s PMDA, determine the device’s classification, and receive precise guidance on the clinical requirements for the device.