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ISO 13485

Medical Device Regulatory Quality Standards - Importance of ISO13485

ISO13458 is becoming widely accepted as the quality management systems standard for Medical Device manufacturers throughout the world. This international standard specifies requirements for regulatory purposes for medical device manufacturers. The main goal of ISO13458 is to provide a unified model for quality management system requirements in the international market since different countries might have different standards.

The standard is based on the ISO9001 process model (plan-do-check-act) and provides a good base model for compliance with global regulatory requirements. In addition to that ISO13458 contains the requirement applied for medical devices. The additional requirements are: 4.2.1 Technical File (DMR), 4.4 Clinical Data, 4.4.1 Risk Analysis, 4.4.4 Safety Requirements.

Medical device is used for human especially for patient, and it has direct effect to human life and health. With these characteristics, regulation for medical device requires higher level of safety standard than general devices. Therefore attention is focused on how such companies will manage risk related to their products and services.

Under the revised Pharmaceutical Affairs Law, manufacturers and distributors of controlled medical devices and in vitro diagnostics (ClassⅡ) specified by the Ministry of Health, Labor and Welfare will be required throughout Japan to establish a system that companies with ISO13485 based on third party certification, which will apply as of April 2005. A company will no longer be able to trade in the domestic market without third party certification of a corporate quality management system which gives priority to risk management in the provision of its products rather than the its own assessment. For manufacturers and distributors of medical devices and in vitro diagnostics, risk management, which essentially means the introduction of ISO13485, will be watershed in deciding whether those companies will continue to exist in the future.


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