The knowledge and compliance with regulatory requirement is a key to success in development and marketing of medical devices. High quality and well-designed medical devices are necessary to provide safe and effective clinical care for patients as well as to ensure the health and safety of professional and lay device users. For this purpose one have to review the regulations in different countries for assuring safety and efficacy of medical devices.The primary goal is to protect public health and safety. A regulatory system should ensure that valuable new technologies are made available to the clinical community and to patients and consumers expeditiously while preventing unsafe or ineffective devices from reaching the market.. Regulatory decisions must be based on strong and clear science, free of external influences and consistent with the directives of law. As the guarantor of public health, enforcement of the law must be vigorously, fairly and uniformly carried out and appropriate regulatory and legal actions taken against violators. Government-prescribed rules and procedures must be clearly articulated for those who must comply with them.
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