Dec 17, 2014
In conjunction with the recent implementation of the Pharmaceutical and Medical Device Act (PMD Act), Japanese regulators have launched a new pre-consultation program to assist registrants as they begin their device certification application processes.
The Taimenjogen program, launched in late November 2014 concurrent with the PMD Act’s implementation, includes six different pre-certification PMDA consultation options at various price points, and is intended to further clarify Japanese registration requirements for manufacturers.
The PMDA’s pre-consultation options include:
Although not as straightforward as the US Food and Drug Administration’s Pre-Submission consultation system for registrants, the PMDA’s pre-consultation program nonetheless allows manufacturers unfamiliar with Japanese pre-market certification and approval requirements to get a better idea of the steps necessary for obtaining market authorization.
Revised medical device registration and approval requirements in Japan will become law November 25, 2014, and will impact several compliance areas for foreign manufactures active in the market, According to Emergo’s Tokyo office.