Go to Client Portal
NAMSA

Update: PMDA Review Timelines for Medical Device and IVD Products

The Pharmaceutical and Medical Devices Agency (PMDA) is an independent administrative institution responsible for ensuring the safety, efficacy and quality of pharmaceuticals and medical devices in Japan. One of the major functions of this agency is to review marketing applications of medical devices and in vitro diagnostic (IVD) products. In recent years, the PMDA has provided sponsors an annual report on review performance to assist in understanding the predictability and associated timelines for regulatory approval.

Japan Issues Amended Pharmaceuticals and Medical Devices (PMD) Act

TOLEDO, OHIO (BUSINESSWIRE) — January 7, 2019 — NAMSA®, the world’s only Medical Research Organization (MRO) that accelerates medical device development through integrated laboratory testing, clinical research …