Firms Marketing In Japan Should Plan For License Renewals Under New Law
This article was originally published in The Gray Sheet
Executive Summary
Device manufacturers that obtained a Japanese marketing license ("kyoka") in Japan before the revised Pharmaceutical Affairs Law (PAL) went into effect last April should allow time to come into compliance before the license expires, according to Steve McRoberts, global principal engineer at Underwriters Laboratories
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Japanese quality system measures
Device firms selling in Japan should be aware that transitional quality system measures under Japanese Good Manufacturing Practice regulations will come into effect in April, according to Amanda Pack, senior project engineer and lead auditor for Underwriters Laboratories. Manufacturers pursuing certification of Class I and some Class II devices by a third party in Japan will have to adhere to the new manufacturing standards to receive a five-year certificate for their devices, but those firms that already have certifications will only have to adhere to the new standards when they apply for recertification, Pack said. Speaking during a Feb. 15 Regulatory Affairs Professionals Society webcast update on Japan regulatory practices, she noted that the transitional measures include review protocol, risk management, design and development protocol and others. Enacted under the Pharmaceutical Affairs Law in April 2005, the JGMP is similar to ISO 134859, the international quality systems standard (1"The Gray Sheet" Jan. 16, 2006, p. 8)...
Japanese quality system measures
Device firms selling in Japan should be aware that transitional quality system measures under Japanese Good Manufacturing Practice regulations will come into effect in April, according to Amanda Pack, senior project engineer and lead auditor for Underwriters Laboratories. Manufacturers pursuing certification of Class I and some Class II devices by a third party in Japan will have to adhere to the new manufacturing standards to receive a five-year certificate for their devices, but those firms that already have certifications will only have to adhere to the new standards when they apply for recertification, Pack said. Speaking during a Feb. 15 Regulatory Affairs Professionals Society webcast update on Japan regulatory practices, she noted that the transitional measures include review protocol, risk management, design and development protocol and others. Enacted under the Pharmaceutical Affairs Law in April 2005, the JGMP is similar to ISO 134859, the international quality systems standard (1"The Gray Sheet" Jan. 16, 2006, p. 8)...
Japanese Quality System Measures
Device firms selling in Japan should be aware that transitional quality system measures under Japanese Good Manufacturing Practice regulations will come into effect in April, according to Amanda Pack, senior project engineer and lead auditor for Underwriters Laboratories