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ME Consulting Co.,Ltd |
| New Introduction of a Third Party Certification System for Controlled Medical Devices (Class II) in Japan |
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| Under the newly introduced Pharmaceutical Affairs Law ( Revised PAL) in April,2005, the product approval system features a four classification of medical devices according to risk, and the revised PAL introduced a third party certification system for pre-market approval of "designated controlled medical devices", which correspond to Class II medical devices, with certification criteria defined by the Minister of the Ministry of Health, Labor and Welfare (MHLW). Marketing Authorization Holders (MAH) (or nominated MAHs on behalf of foreign manufacturers) must obtain conformity certification for each medical device from an accredited third party certification body registered by the MHLW.
The accredited third party certification bodies, registered by the MHLW in April, 2005, assess conformity to the certification criteria and conformity to the essential principle, which corresponds to the essential principle proposed by the Global Harmonization Task Force (GHTF). At the same time, third party certification bodies perform GMP site inspection (or document assessment) to assess conformity of each product to the new GMP standards, which are based on ISO13485:2003 in principle, but not exactly the same.
Under the revised PAL, medical devices are separated into four classes according to risk : Classes I, II, III and IV. Among the Class II medical devices ( 1,785 products), the MHLW specified about 820 products as "designated controlled medical devices", which will require the conformity certification from the accredited third party certification bodies prior to the market introduction.
Application documents required for certification assessment include;
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A set of an application form ( as specified by each certification assessment body) |
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Certification application form ( Form 64) and necessary attachment documents including;
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(a) Evidence documents to demonstrate conformity to the certification criteria (JIS standards) and
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(b) Evidence documents to demonstrate conformity to the essential principle
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GMP conformity inspection/investigation application form ( Form67) and other necessary documents ( e.g. quality manual etc)
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A typical example of procedures for the submission of an application for certification assessment by a third party certification body is indicated in the attached diagram.(PDF)
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 Copyright(c) 2004 ME Consulting Co., Ltd. All rights reserved.
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