జర్నల్ ఆఫ్ మెటీరియల్ సైన్సెస్ & ఇంజనీరింగ్

Development of New Medical Technologies: from Biomaterials to Medical Device â?? The Regulatory Considerations and Compliance

Abstract

Gabriel O Adusei

The new medical technologies are transforming the delivery and management of health care.  The investment and interest in research, design and development of new medical technologies are growing and making their way into the healthcare systems at a faster rate than ever. Whilst the scientists, engineers and clinicians collaborate in the bringing of new medical technologies to the commercial stage, there are three main factors to ensure their approval, namely quality, efficacy (performance) and safety.  These aspects of the technology are subjected to regulatory scrutiny and approval process by Regulatory Agencies or Authorities. 

Typical responsibilities of a Regulatory Agency or Authority (e.g. US FDA, UK MHRA, Germany ZLG, Netherlands IGZ, and Ireland HPRA) are protecting the public health by ensuring the quality, safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and the scope may be extended to cover ensuring the safety of food supply, cosmetics, and products. Some agencies are responsible for advancing the public health by helping to speed innovations that make medical products more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medical products and foods to maintain and improve their health.

The regulatory approval processes are based on scientific, technical and clinical evidence that the appropriate tests, verifications and validations have been conducted to support the clinical claims as per the approved indication(s) for use with adequate information to ensure the medical device can be used as intended. No biomaterial progresses to be considered as medical device for use without being subjected to some regulatory scrutiny.IMDRF has been working on the harmonisation of regulations at the global level to help facilitate the process of meeting the regulatory requirements and bringing new technologies to the end-users. This promotes Mutual Recognition Agreement (MRA) to allow inspectors to rely upon information from inspections conducted within each other’s borders.