Medical devices and pharmaceuticals continue to gain momentum, entering new markets around the world and providing technological advances in disease management in a variety of conditions. However, such interventions can also carry predictable and unpredictable risks and, under certain circumstances, can have immediate, life-threatening consequences. Regulators assessing market approval for new products should weigh the potential benefits and risks of the proposed treatment options.
Since the revision of medical devices to the Federal Food, Drug, and Cosmetic Act (FDCA) in 1976, the Food and Drug Administration (FDA) has been obliged to ensure the “reasonable safety and effectiveness” of new products. FDA-Approved as the only mechanism by which manufacturers bring medical devices to the United States for use in patient care 9. Subsequent legislation added manufacturer user fees and performance targets for government evaluation periods. 10,112012 The FDA’s Safety and Innovation Act (FDASIA) maintains a general device rating structure and extends usage and performance targets until 2017
Medical devices and pharmaceuticals are regulated in the EU in the same way as other consumer products. There are no medical devices that comply with the European Medicines Agency. After being certified by the Notified Body (NB), a private commercial organization based in member countries specializing in the European Medicines Agency (Conformité Européenne), it can be legally sold in the EU. CE) Mark rating of medical devices or other consumer products. The 14,15,16CE marks indicate that the device is “compliant” with relevant directives regarding manufacturing, labeling, and expected performance and safety profiles. Approval from one of the EU’s over 70 NBs enables marketing in all Member States. Each country also has a state competent authority (CA) that oversees the notification body and is primarily responsible for post-approval monitoring. The structure, staffing, financing and function of competent authorities varies widely from country to country. Individual certification bodies and notifying bodies have the flexibility to establish procedures that they consider sufficient to meet the requirements of the guidelines
Japan’s equipment regulations are centrally managed by the Medical devices and pharmaceuticals agency and the Ministry of Health, Labor and Welfare (MHLW) 22. Under the Japanese Pharmaceutical Affairs Law, MHLW approves the approval of new devices and oversees post-approval monitoring activities. 23 MHLW decisions are based on PMDA analysis and include on-site inspections and premarket reviews of new technologies, including non-clinical and clinical evaluations. PMDA also establishes policies related to medical device testing, approval, marketing, distribution, and monitoring
Municipalities play a supporting role in administrative work, coordination of routine inspections, and assessment of compliance with established standards for manufacturers (called “medical license holders [MAH]”) and facilities. An important premise of an organization is that MAH has the primary responsibility for ensuring safety and effectiveness24. Regulations on the identification of safety signals generated in the international market and on quality systems and post-registration investigation
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