ISO 13485 Consulting and Implementation for Medical Device Manufacturers
ISO 13485:2003 is a quality system standard designed specifically for medical device companies, and is the most commonly chosen path for companies to meet the QMS requirements in Europe, Canada, Japan, Australia and other countries.The ISO 13485 standard has many of the same requirements as ISO 9001:2008. However, there are additional requirements for process control, design control, retention of records, accountability, traceability, customer feedback and more.
Although implementing ISO 13485 is voluntary for manufacturers selling in Europe, most companies opt to apply this standard to demonstrate compliance with the Directives. In Canada, ISO 13485:2003 is mandatory for Class II, III and IV medical device manufacturers, with additional requirements imposed under Canadian law. Compliance with Japan’s Ministerial Ordinance #169 is quite similar to ISO 13485 with additional requirements imposed under Japan law.
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Medical Device Vigilance Reporting in Taiwan
The Taiwan Food and Drug Administration (TFDA) requires medical device manufacturers to comply with a vigilance system for post-market monitoring and adverse event reporting.
Taiwan’s Pharmaceutical Affairs Act and the Regulation of Reporting Serious Adverse Reactions offer valuable information on terminology, timelines and other vigilance reporting requirements in Taiwan.
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修正前後比較
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《醫療器械註冊管理辦法》（國家食品藥監督總局令第 4號）
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《醫療器械監督管理條例》
（國務院令第 650號）
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目錄
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TABLE OF CONTENTS
1. Introductions 1
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GUIDELINES FOR TAKING ACTION ON SAMPLES OF DRUGS DECLARED SPURIOUS OR NOT OF STANDARD QUALITY IN THE LIGHT OF ENHANCED PENALTIES UNDER THE DRUGS AND COSMETICS (AMENDMENT) ACT, 2008
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