Medical Regulatory Affairs PDF

Unit wise Material Unit Unit Outcomes (UOs) Topics and Sub-topic 1.a. Describe the Role and functions of regulatory agencies 1.1 Role of Regulatory Affairs in the 1.b. D...

Unit wise Material Unit Unit Outcomes (UOs) Topics and Sub-topic 1.a. Describe the Role and functions of regulatory agencies 1.1 Role of Regulatory Affairs in the 1.b. Define FDA Biomedical Industry 1.c. Define EMA 1.d. Define CDSCO 1.2 Regulatory Agencies and their 1.e. Describe role and functions of CDSCO Functions : FDA (U.S. Food and 1.f. Give classification of medical device Drug Administration), EMA based upon medical regulations (European Medicines Agency), 1.g. Enumerate Regulatory requirements for The Central Drugs Standard Control different device classes Organization(CDSCO), IPC, NPPA Unit – I and Other global regulatory Introduction to medical authorities Regulatory Affairs 1.3 Classification of Medical device a per FDA 1.4 Classification of Medical device a per CDSCO 1.5 Regulatory requirements for different device classes Medical Device definition as per Global Harmonization Task Force(GHTF): Medical device” means any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purposes of: Diagnosis, prevention, monitoring, treatment or alleviation of disease Diagnosis, monitoring, treatment, alleviation of or compensation for an injury Investigation, replacement, modification, or support of the anatomy or of a physiological process supporting or sustaining life Control of conception 1 M.H.DAVE-G.P.GANDHINAGAR  Disinfection of medical devices providing information for medical purposes by means of in vitro examination of specimens derived from the human body and which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means. 1.1 Role of Regulatory Affairs in the Biomedical Industry 1. Describe the Role and functions of regulatory agencies of medical device Medical device regulatory agencies are specialized regulatory bodies responsible for overseeing the safety, efficacy, and quality of medical devices. These agencies play a crucial role in ensuring that medical devices meet the necessary standards and regulations to protect public health and safety. Here are the key roles and functions of medical device regulatory agencies: 1. Regulatory Framework Development: These agencies develop and establish regulations, guidelines, and standards for the design, manufacturing, labelling, and distribution of medical devices. They ensure that these regulations align with international standards and best practices. 2. Pre-Market Approval: Regulatory agencies review and evaluate medical devices before they are allowed to be marketed and sold. They assess the safety, performance, and effectiveness of the devices through rigorous testing, clinical trials, and documentation review. This process helps to ensure that only safe and effective devices reach the market. 3. Post-Market Surveillance: Regulatory agencies monitor medical devices that are already on the market to identify any potential safety issues or adverse events. They collect and analyse data from various sources, such as healthcare providers, patients, and manufacturers, to detect and investigate any reported problems. This surveillance helps to ensure ongoing device safety and effectiveness. 4. Quality System Regulation: Regulatory agencies establish and enforce quality system regulations that medical device manufacturers must adhere to. These regulations cover areas such as design controls, manufacturing processes, labelling, packaging, and post-market surveillance. Compliance with these regulations ensures that devices are consistently produced and controlled to meet quality standards. 5. Inspections and Audits: Regulatory agencies conduct inspections and audits of medical 2 M.H.DAVE-G.P.GANDHINAGAR device manufacturers to assess their compliance with regulations and quality standards. These inspections may include facility inspections, documentation reviews, and product testing. Non-compliance can result in enforcement actions, such as warning letters, fines, or product recalls. 6. International Collaboration: Medical device regulatory agencies often collaborate with other regulatory bodies at the national and international levels to harmonize regulations, share information, and promote global regulatory consistency. This collaboration helps to streamline the regulatory process and facilitate the international trade of medical devices. By fulfilling these roles and functions, medical device regulatory agencies ensure that medical devices meet the necessary safety and performance standards, providing confidence to healthcare professionals and patients alike. 1.2 Regulatory Agencies and their Functions : FDA (U.S. Food and Drug Administration), EMA (European Medicines Agency), The Central Drugs Standard Control Organization(CDSCO), IPC, NPPA and Other global regulatory authorities 2. Define FDA The FDA, or the U.S. Food and Drug Administration, is a regulatory agency within the United States Department of Health and Human Services. Its primary role is to protect and promote public health by regulating various products, including food, drugs, medical devices, vaccines, biologics, cosmetics, and tobacco products. Functions: Product Approval, Food Safety, Medical Device Regulation, Drug Safety Monitoring, Tobacco Regulation, Compliance and Enforcement, Public Education and Outreach 3. Define EMA EMA stands for the European Medicines Agency. It is a regulatory agency responsible for the evaluation, supervision, and monitoring of medicines in the European Union (EU). The EMA plays a crucial role in ensuring the safety, efficacy, and quality of medicinal products available in the EU market. Functions: 3 M.H.DAVE-G.P.GANDHINAGAR  Evaluation of Medicines, Regulatory Guidance, Pharmacovigilance, Scientific Committees, Collaboration and Harmonization, Public Information Overall, the EMA plays a crucial role in safeguarding public health by ensuring the quality, safety, and efficacy of medicines available in the European Union. 4. Define CDSCO CDSCO stands for the Central Drugs Standard Control Organization. It is the regulatory agency responsible for the regulation and control of pharmaceuticals and medical devices in India. CDSCO operates under the purview of the Ministry of Health and Family Welfare. The role and functions of CDSCO include: 1. Drug Approval: CDSCO is responsible for the approval of new drugs, clinical trials, and import/export of drugs in India. It evaluates the safety, efficacy, and quality of pharmaceutical products before granting marketing authorization. 2. Regulation and Licensing: CDSCO issues licenses to pharmaceutical manufacturers, importers, and distributors to ensure compliance with quality standards and good manufacturing practices. It also regulates the import and export of drugs and medical devices. 3. Quality Control: CDSCO conducts inspections and quality control tests to ensure that drugs and medical devices meet the required standards. It monitors the manufacturing, distribution, and sale of pharmaceutical products to prevent the circulation of substandard or counterfeit drugs. 4. Pharmacovigilance: CDSCO monitors and evaluates the safety of drugs and medical devices in the market. It collects and analyses adverse drug reactions and takes appropriate regulatory actions to protect public health. 5. Regulatory Guidelines: CDSCO formulates and updates regulatory guidelines and standards for the pharmaceutical industry. It provides guidance to manufacturers, importers, and other stakeholders on compliance with regulatory requirements. 6. Collaboration and International Harmonization: CDSCO collaborates with international regulatory agencies and participates in initiatives for harmonizing regulatory standards. It works towards aligning Indian regulations with global practices to facilitate international trade and ensure patient safety. 4 M.H.DAVE-G.P.GANDHINAGAR  Overall, CDSCO plays a crucial role in ensuring the safety, efficacy, and quality of pharmaceuticals and medical devices in India. It works towards protecting public health and promoting the development of a robust and regulated healthcare industry. 5 M.H.DAVE-G.P.GANDHINAGAR 5. Other global regulatory agencies: Sr.No Country Authority 1 USA USFDA 2 UK MHRA 3 Australia TGA 4 India CDSCO 5 CANADA HEALTH CANADA 6 South Africa MCC 7 Brazil ANVISA 8 European Union EMEA 9 China SFDA 10 Nigeria NAFDAC 11 New Zealand MEDSAFE 12 Japan MHLW 13 Zimbabwe MCAZ 14 Switzerland SWISSMEDIC 15 Korea KFDA 16 Sri Lanka MoH The International Medical Device Regulators Forum (IMDRF) is a group of medical device regulators from around the world that have voluntarily come together to harmonize the regulatory requirements for medical products that vary from country to country. The current IMDRF members represent medical device regulatory authorities in:  Australia - Therapeutic Goods Administration  Brazil - National Health Surveillance Agency (ANVISA)  Canada - Health Canada  China - China Food and Drug Administration  Europe - European Commission Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs  Japan - Pharmaceuticals and Medical Devices Agency and the Ministry of Health, Labour and Welfare  Russia - Russian Ministry of Health  Singapore - Health Sciences Authority  South Korea - Ministry of Food and Drug Safety  United States - U.S. Food and Drug Administration 6 M.H.DAVE-G.P.GANDHINAGAR The World Health Organization (WHO) is an Official Observer. 1.3. Classification of Medical device a per FDA The FDA categorizes medical devices into one of three classes – Class I, II, or III – based on their risks and the regulatory controls necessary to provide a reasonable assurance of safety and effectiveness. Class I devices generally pose the lowest risk to the patient and/or user and Class III devices pose the highest risk. Class I devices, and a handful of exempt Class II devices, are exempt from premarket notification and approval processes, while Class III and the majority of Class II devices require active dialog with an investigation by the FDA. Another type of device may be exempt from some regulatory controls, depending on its intended use. The FDA defines Class I devices as: "not intended for use in supporting or sustaining life or of substantial importance in preventing impairment to human health, and they may not present a potential unreasonable risk of illness or injury." These devices are the most common class of devices regulated by the FDA, constituting 47% of approved devices on the market. Class I devices have minimal contact with patients and low impact on a patient's overall health. In general, Class I devices do not come into contact with a patient's internal organs, central nervous system or cardiovascular system. These devices are subject to the fewest regulatory requirements. Class I medical device examples  Electric toothbrush  Tongue depressor  Oxygen mask  Reusable surgical scalpel 7 M.H.DAVE-G.P.GANDHINAGAR   Bandages  Hospital beds  Non-electric wheelchair Bringing Class I medical devices to market As you might expect, Class I devices are the fastest and easiest to bring to market since they present the lowest amount of risk to the patient and are rarely critical to life-sustaining care. The majority of Class I devices are exempt from FDA requirements for Premarket Notification (510(k)) and Premarket Approval (PMA). Class I devices are not exempt from FDA General Controls, a series of commands which applies to Class I, II and III medical devices. The provisions of General Controls address adulteration, misbranding, device registration, records and good manufacturing practices. Medical device manufacturers who fall into Class I are still required to implement a quality management system and follow standards to ensure a quality product. FDA Class II medical device Class II medical devices are more complicated than Class I devices and present a higher category of risk because they are more likely to come into sustained contact with a patient. This can include devices which come into contact with a patient's cardiovascular system or internal organs, and diagnostic tools. The FDA defines Class II devices as: “Devices for which general controls are insufficient to provide reasonable assurance of the safety and effectiveness of the device.” Class II medical device examples  Catheters  Blood pressure cuffs  Pregnancy test kits  Syringes 8 M.H.DAVE-G.P.GANDHINAGAR   Blood transfusion kits  Contact lenses  Surgical gloves  Absorbable sutures Bringing Class II medical devices to market Controls vary depending on the device, but according to the FDA, can include:  Device performance  Post-market surveillance  Patient registries  Special labelling requirements  Premarket data requirements  Guidelines Class II devices are subject to the same General Controls mentioned above, as well as Special Controls. These regulations depend on the device and may include special labeling requirements, patient registries and performance standards. FDA Class III medical device: The FDA defines Class III devices as products which: “Usually sustain or support life, are implanted or present a potential unreasonable risk of illness or injury." Just 10% of the devices regulated by the US FDA fall into Class III. This classification is generally extended to permanent implants, smart medical devices and life support systems. Class III medical device examples  Breast implants  Pacemakers  Defibrillators  High-frequency ventilators  Cochlear implants  Fetal blood sampling monitors  Implanted prosthetics 9 M.H.DAVE-G.P.GANDHINAGAR Bringing Class III medical devices to market Class III devices are subject to all General Controls and the FDA's Premarket Approval (PMA) process. The FDA writes that 'general and special controls alone are insufficient to assure the safety and effectiveness of Class III devices'. 1.4 Classification of Medical device a per CDSCO Medical Device is classified as: 1. Notified device: notified medical devices are medical devices that are regulated under medical devices rules 2017, CDSCO 2. Non notified device: Non notified medical devices are medical devices that have not been mentioned under notifies devices in the office gazette released by government of India CDSCO Classification for Medical Devices Risk-based Classifications: Medical devices are classified into four classes (A, B, C, and D) based on the risk of their intended usage as shown in figure 1. Medical Devices are generally based on risks; the actual risk-based classification of the medical device depends upon its intended use and purpose. CDSCO classification for medical devices has a larger group of devices, such as cannulas and stents in more specific subgroups. 10 M.H.DAVE-G.P.GANDHINAGAR  Fig: 1 classification of medical device as per CDSCO Medical Devices and IVD are classified into four categories, depending upon the indications for use and risk level of the device (New Medical Device Rules 2018) Four classes (Class A, B, C, and D) have been set up under the new system, where Class A and B present the least risk and Class C and D devices present higher risks to patients. For example, 1. An elastic bandage or a mechanical barrier used for pressure or for ingestion of exudates for wounds that have not ruptured the dermis and can be healed by essential expectation would be classified as a Class A device. 2. A case of a Class B medical device is contact lens points though a blood sack that doesn’t consolidate a medicinal product would be viewed as a Class C device. 3. Lastly, a transient-utilize surgically obtrusive medical device expected to be utilized explicitly in direct contact with the central nervous system or for the diagnosis, checking, or adjustment of a heart defect or central circulatory framework condition through direct contact with body parts would be a case of a Class D device. 11 M.H.DAVE-G.P.GANDHINAGAR  1.5 Regulatory requirements for different device classes 1. Device Classification When it comes to medical devices, classification is almost always a requirement, no matter the regulatory authority. Medical devices are usually classified depending on their risk level, which is important in establishing the level of regulatory control and the type of premarket submission necessary. 2. Safety and effectiveness data Safety and effectiveness or performance is really one of the key requirements of any medical device. Extensive clinical research and testing are also carried out to ensure the device's dependability and functionality. Regulatory authorities may ensure that medical devices are safe and effective and meet the highest quality and reliability standards. 3. Quality System Regulations A good Quality Management System (QMS) will undoubtedly be a part of the regulatory criteria. When it comes to medical devices, QMS covers the complete lifespan of the medical device, from design and development to manufacturing and distribution, even after it is in the market. The QMS guarantees that all processes and activities linked to the medical device are managed, recorded, and constantly improved to assure product safety, efficacy, and compliance with applicable requirements. 4. Medical device listing and registration Most regulatory authorities call for medical device listing and registration of some form these days. In the EU, you have to register your device and assign it a Unique Device Identifier (UDI). The UDI is a string of numbers or letters that is unique to each medical equipment. This requirement is significant since it aids in the identification and tracking of medical equipment on the market. Hence, when and if adverse events occur, the tracked device can be pulled and the cause analysed. 5. Surveillance and Vigilance A strong surveillance and vigilance system is equally important as proving safety and performance. The system ensures that necessary actions are made to protect patients by quickly detecting and addressing any potential concerns or adverse events. It entails a comprehensive approach that includes detailed data analysis, proactive risk management, and timely contact with regulatory authorities and healthcare specialists. In India – CDSCO has certain regulatory requirements like:  Regulatory Body  Device Classification  Device Registration and Licensing  Clinical Trials  Import License 12 M.H.DAVE-G.P.GANDHINAGAR References: 1. https://www.fda.gov/medical-devices/cdrh-international- affairs/international-medical-device-regulators-forum-imdrf 2. https://www.researchgate.net/publication/301637817_DRUG_REG ULATORY_AGENCIES_IN_INDIA_USA_EUROPE_AND_JAPAN- A_REVIEW 3. https://www.fda.gov/medical-devices/overview-device- regulation/classify-your-medical- device#:~:text=Class%20I%20includes%20devices%20with,I%2C%2 0II%2C%20and%20III 4. https://operonstrategist.com/cdsco-classification-for-medical- devices/ 5. https://operonstrategist.com/rehabilitation-medical-devices/ 6. https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2022/ m_device/Medical%20Devices%20Rules,%202017.pdf 7. https://www.asphalion.com/overview-of-medical-device- regulations/ 8. MEDICAL DEVICE REGULATIONS- Global overview and guiding principles- WHO GENEVA 9. https://www.fda.gov/training-and-continuing-education/fda- learning-portal-students-academia-and-industry 13 M.H.DAVE-G.P.GANDHINAGAR