Worldwide Medical Device Regulatory Updates

As medical device quality assurance and regulatory affairs professionals, it can be challenging to stay on top of changes happening in our industry. Few people have the time to read lengthy articles these days and although many online newsletters exist, they are often packed with PR releases, ads or unrelated information. That\'s why we started this blog for QA/RA professionals in the medical device and IVD industry. The idea is to give you short updates on quality and regulatory topics that may be of interest to you. No fluff, just straight to the point. We hope you\'ll enjoy the content.

JFMDA Pushes for Industry-Specific Regulatory Framework

The Japan Federation of Medical Device Associations (JFMDA) has begun pushing for regulations specifically targeting the medical device industry ahead of plans next year to revise the country’s Pharmaceutical Affairs Law (PAL).

According to medtechinsider.com, JFMDA chairman Kazuo Ogino held a press conference March 25 to argue that the PAL’s current iteration has bogged down development of innovative medical technologies in Japan because the law treats devices and pharmaceutical products in the same regulatory fashion.

Although the Japanese Health, Labor and Welfare Ministry has given no indication that it plans to include new rules targeting only medical devices in the 2012 PAL revision, the JFMDA will lobby for such requirements as a fast-track approval system for upgraded products that have already gone through the device approval process once.

A formal petition will be filed at some point with the ministry, according to Ogino.

Markets: JapanCategories: Regulatory ComplianceTags: Japan, JFMDA, PAL, Pharmaceutical Affairs Law

Author: Stewart EisenhartDate: March 30, 2011

JFMDA Urges Prioritization of Power Allocation to Meddev Manufacturers

The Japanese government should prioritize power supply allocation to medical device manufacturing facilities producing life-saving and sustaining devices such as ventilators, oxygen supply products and defibrillators.

So argues Kazue Ogino, Japan Federation of Medical Device Associations (JFMDA) chairman, according to the blog medtechinsider.com. Ongoing rolling blackouts throughout the country following the massive earthquake and tsunami earlier this month have spawned production and logistical challenges for manufacturers to ensure adequate supplies of such devices.

Writing to the Japanese health and economic ministries, Ogino requested allowances for additional electricity and gasoline to enable manufacturers to both produce appropriate devices and distribute them to disaster-stricken areas.

Markets: JapanCategories: Regulatory ComplianceTags: distribution, Japan, JFMDA, tsunami

Author: Stewart EisenhartDate: March 21, 2011