Jan 9, 2017

Gebührensenkung bei Qualitätssystembewertungen in Japan

ZUSAMMENFASSUNG DER WESENTLICHEN PUNKTE DURCH EMERGO: Für Medizinprodukte der Klasse II werden die Gebühren für...
Jan 23, 2013

Japanische Behörden erleichtern die Anforderungen bei Haltbarkeitsprüfungen von Medizinprodukten

Das japanische Ministerium für Gesundheit, Arbeit und Soziales hat manche Medizinprodukte, für die ein Zulassungsantrag...
Jan 22, 2013

Japanese Regulators Relax Medical Device Stability Testing Requirements

Japan’s Ministry of Health, Labour and Welfare has exempted stability test report requirements for some...
Jun 25, 2012

Japanese Government Open to Medical Device Regulation Revisions

The Japanese government is reportedly considering changes to its Pharmaceutical Affairs Law (PAL) that would...
Jan 26, 2012

Mexico Expands Equivalency to Devices Registered in Japan

Mexican medical device regulator COFEPRIS has extended its Equivalency Agreement granting expedited reviews for some medical device
Aug 4, 2011

JFMDA Pushing for More Flexible Accreditation System in Japan

The Japan Federation of Medical Device Associations (JFMDA) has filed a petition with the country’s...
Jun 13, 2011

Japanese Trade Groups Urge Creation of Pan-Asian MedTech Community

The Japan Federation of Medical Device Associations (JFMDA) and the Medical Engineering Technology Industrial Strategy consortium (METIS), Japan’s two largest medical device and technology tr
Jun 3, 2011

FDA Issues Advisory on Medical Device Components Imported from Japan

The US FDA’s Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation...
Mar 30, 2011

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 Pharma
Mar 21, 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 an

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