A large medical device manufacturer, faced one frustrating challenge while seeking approval for antimicrobial central venous catheters and antimicrobial dressings in Japan. There seemed to be an inconsistency in the Pharmaceuticals and Medical Devices Agency’s (PMDA) clinical data requirements; clinical evaluations for the products of some of our client’s competitors were deemed sufficient by the agency while clinical data was demanded for the products of others. The company needed a better understanding of which category their products would fall into, so they enlisted RegDesk’s expert help.
The PMDA’s regulatory framework consists of three general routes to approval: “todokede”‚”ninsho”‚ and “shonin.” Todokede is the pathway used to evaluate low-risk medical devices; products that fall in this category typically require only a marketing notification. Most medium-risk and some high-risk medical devices are approved via the ninsho process; third-party certification is required of devices in this category. Lastly, the shonin route is used for some medium-risk devices and most high-risk devices; these products must be reviewed by PMDA itself.
While Japan”s regulatory agency does have three distinct approval processes for medical devices, the boundaries between them are not so clear. A gray area is especially present between the ninsho and shonin pathways. RegDesk”s challenge was to demystify this gray area for the client.
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 its discretion when deciding which higher-risk medical devices require clinical evaluations and which ones require clinical data.
After receiving RegDesk’s report, the client was able to construct the optimal plan of action that would secure approval for their medical device. The company scheduled a consultation with Japan’s PMDA, worked with the agency to determine the classification of the device, and received precise guidance on the clinical requirements for the device.
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