Global medical device regulations
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Global medical device regulations
Medical devices make a huge market with a steady growth rate. It is predicted that the medical devices market will touch $400 billion in 2017, from its volume in the roundabouts of $320 billion in 2012. This means that the industry is growing at a healthy rate. Regulation in this industry, which has always been necessary and very stringent, will continue to be a driving force for the industry in the years to come, with the high numbers of medical devices entering the market year after year and with their use likely to be directed at the geriatric population. www.netzealous.com
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The expansion and growth of the medical devices market have made regulation both important and challenging. The sheer variety and number of medical devices is a major reason for this, because anything from a tongue depressor to devices that use sophisticated software technology to measure vital parameters or carry out surgeries are part of medical devices.
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No getting away from regulation Yet, regulation is extremely important, for the core reason that it should bring about safety among the users of medical devices. Any medical device should primarily aid in bringing about an improvement in the quality of healthcare and the quality of life of the patient and a reduction of the use of products that do not guaranteed these. Global regulation for medical devices seeks to bring about an improvement in the development and use of diagnostics, as well, as a tool for ensuring good health globally. Global medical device regulations aim to reduce adverse events associated with the use of medical devices, although the definition of the event itself could vary and at improving the effectiveness of the device. www.netzealous.com
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Regulation should aim to bring about harmonization Regulations are important to also bring about harmonization and standardization in a number of processes and parameters in the industry. For this reason, the world health organization and other bodies have been at the forefront of making regulations that are of a global nature. No matter how benign this intention, the WHO itself admits that no regulation can bring in an absolutely safe product. Yet, there have been consistent efforts to bring about regulation at some level, so that there is an element of conformity with a few standards at the global level. The WHO carries out meeting at different locations and at different times to discuss with member states the ways of strengthening the regulatory framework and working ways of implementing these globally in a uniform manner. www.netzealous.com
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Regulations from the WHO are not just global in their application; they are also comprehensive in that they are for all types of devices, such as Class I, Class II and Class III medical devices, and cover all stages of the manufacture of the medical device, such as:
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• Conceptualization and development • Manufacture • Packaging and labeling • Advertising • Sale • Use of the product • Ways in which the medical device is to be disposed after use The WHO also sets out the role to be played by the various players in the chain, such as the manufacturer, the vendor, the user, the general public, the government and so on. www.netzealous.com
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The GHTF –now replaced by the IMDRF Although a number of regulations are present in various countries of the world and in blocs such as the EU and the medical device regulatory bodies in these markets are free to formulate their own regulations; there is the existence of a global instrument, the Global Harmonization Task Force (GHTF), now known as the International Medical Device Regulators Forum (IMDRF).
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The IMDRF is a takeoff from the GHTF. It is a mechanism for exchanging information about medical devices that helps the countries of the world bring in a level of harmonization and standardization in the medical device regulations around the world. Being a voluntary program; the IMDRF consists of officials who represent the regulatory bodies of their respective countries, and members of the regulated industries
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Core purposes of the IMDRF A task force that is tasked with the formulation and implementation of regulatory guidelines; the IMDRF has the following purposes: • Encouraging synchronization of the regulatory practices of different countries • Promoting the wellbeing of patients by boosting the quality, efficiency and performance of medical devices by harmonizing regulations • Bringing about greater innovation in medical devices through the use of technology • Fostering international trade www.netzealous.com
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Quality Systems regulations for medical devices In addition to the GHTF; there are also the Quality Systems regulations for medical devices that need to be complied with. The Quality Systems regulation for medical devices is the ISO 13485 standard. Considered the benchmark for ensuring quality through standards and processes; the ISO 13485 standards concern the regulations by which the manufacturer designs, manufactures, packages, labels, stores, installs, services and handles post market operations of medical devices. These regulations cover the controls, facilities and methods the manufacturer uses for medical devices. For this reason, the ISO 13485 covers the entire lifespan of the medical device, and usually works in tandem with the regulatory frameworks and systems of individual countries.
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Being the current standard for medical devices; the ISO 13485 offers a set of standards for implementation by medical devices manufacturers. Although enacted as an independent standard; the ISO 13485 is synced with ISO 9001, alongside with which it is implemented. This is because of reasons of complementarity: The ISO 13485 only prescribes steps for implementing Quality Management Systems guidelines as they exist and is not concerned with ways by which these processes can undergo improvement over time. To overcome this, the ISO 13485 standard is to be unified with other guidelines and standards in future in phases. www.netzealous.com
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• The major objective of the ISO 13485 standard is to help medical device manufacturers know how to put a medical device risk management process in place. The aim of this process is to help medical device manufacturers: • Recognize underlying and existing hazards present in the medical device • Evaluate the inborn risks associated with the manufacture of medical devices, and • Develop steps to contain risk and implement and follow up on the extent to which these measures have been effective.
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Risk management and ISO 13485 One of the main characteristics of the ISO 13485 standard is the guidelines it has on ways by which a manufacturer of medical device needs to put a risk management process in place and implement it. The ISO 13485 standard requires these risk management processes which medical device manufacturers have to implement: • Establishing a process that helps it to identify, manage and control the risks relating to a medical device • Entrusting the management with the responsibility of ensuring that the company’s medical devices are subjected to this process • Taking steps to properly and systematically document all the steps that go into this process • Implementing a risk management process is mandatory for all medical device a medical devices company manufactures, which is to be embedded throughout the lifecycle of the medical device • Adherence to the risk management process, which is to be scrutinized and documented at various stages of the device’s lifecycle www.netzealous.com
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