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Focus on Japan Series: Part III – Registering Facilities under Foreign Manufacturer Accreditation (FMA)

Medical device organizations that manufacture products outside of Japan, but plan to market within this geography, are required to obtain accreditation by the Minister of Health, Labour and Welfare (MHLW), or what is referred to as Foreign Manufacturer Accreditation (FMA). A critical step in receiving an FMA includes undergoing proper inspection of manufacturing buildings and … Continued

Why Regional Reimbursement Strategies Could Be Right For Medtech

Originally published in Medical Device & Outsourcing, a MassDevice Resource The medtech space is facing increasing challenges, particularly in the reimbursement space. Although the process is difficult, device makers may find that regional reimbursement strategies better suit their immediate needs to get products to market, according to experts at NAMSA. Let’s start with the challenges. … Continued

Focus on Japan Series: Part II – Understanding the Designated Marketing Authorization (D-MAH) Status for Foreign Device Manufacturers

Over the last few weeks, NAMSA’s Japanese medical device development experts have been discussing a variety of regulatory topics related to Japan’s unique product development and manufacturing landscape. This series is intended to provide helpful information and best practices that lead to successful device operations in this quickly growing device marketplace. Introduction to D-MAH When … Continued

Focus on Japan Series: Part I – Important Factors for Medical Device Development in Japan

Throughout the coming weeks, NAMSA’s Japanese medical device development experts will discuss a variety of regulatory topics related to Japan’s unique product development and manufacturing landscape. This series is intended to provide helpful information and best practices that lead to successful device operations in this quickly growing device marketplace. In Japan, a medical device manufacturer … Continued

NAMSA Expands Service Offering in China with Opening of Shanghai Laboratory

World’s only Medical Research Organization to open preclinical medical device laboratory operations in mid-November. Toledo, OH and Shanghai, Peoples Republic of China – November 2, 2016 – NAMSA, the world’s only Medical Research Organization (MRO), is pleased to announce the opening of its state-of-the-art preclinical medical device research laboratory in Shanghai, China. This opening represents … Continued

FDA Clarifies Policy for Color Additives in Medical Devices

On February 12, 2016, the U.S. Food and Drug Administration (FDA) held a webinar to clarify their current policy in relation to the use of color additives in medical devices. Under Chapter VII, section 721 of the Federal Food, Drug, and Cosmetic, color additives are subject to FDA approval before they may be used in … Continued