CBM357 Medical Device Regulations Syllabus:
CBM357 Medical Device Regulations Syllabus – Anna University Regulation 2021
COURSE OBJECTIVES:
The objective of this course is to enable the student to
To study the regulation of medical devices, process of development, ethical and quality considerations.
To learn the various ISO standards of quality and risk management for regulatory purposes
To explore the process of approval and marketing of medical devices.
To comprehend the regulatory process for medical devices in India, US, and EU.
To familiarize with clinical evaluation and investigation of medical devices.
UNIT I MEDICAL DEVICE REGULATIONS
History of medical device regulation, regulatory affairs professional’s roles, required competencies, medical device classification: scope, definitions, main classifications, Risk based classification, practical examples, labeling of medical devices: definition, elements, risk management, clinical evaluation and labeling, language level and intended users. differentiating medical devices IVDs and combination products from that of pharmaceuticals.
UNIT II ISO STANDARDS
ISO 13485:2016: Requirements for regulatory purposes: Quality Management Systems, certification process. ISO 14971: Application of Risk management to medical Devices.
UNIT III IEC, REGULATORY SYSTEMS IN USA & EU
IEC international standards and conformity assessment for medical devices, Good submission process, medical device regulatory system in the USA and European Union.
UNIT IV INDIAN REGULATORY SYSTEM
India: Medical device regulatory system: market environment, functions undertaken by DGGI, central government, FDA and state governments, guidance documents, details of key regulators, IMDRF and CDSCO, regulatory overview in India, product registration on conformity assessment, quality system regulation, technical material and labeling requirements, commercial aspects, upcoming regulation changes.
UNIT V CLINICAL TRIALS AND DIGITAL REGULATIONS
Regulatory strategy and competitive advantage, Preclinical and Clinical Trial Design for Medical Devices in India; FDA approved devices, post-market surveillance/vigilance, Digital health regulations: Connected care, intelligent design control, reducing design time and cost with in-silico clinical trials
COURSE OUTCOMES:
On completion of the course, the student should be able to:
CO1: Define and explain the basic concepts of medical device regulations.
CO2: Decipher the meaning of ISO standards from a regulatory perspective.
CO3: Explain US-FDA, IEC and European regulations.
CO4: Discuss regulations in India
CO5: Explain the regulatory aspects of clinical trials and digital alternatives
TOTAL:45 PERIODS
TEXTBOOKS:
1. Medical Regulatory Affairs: An International Handbook for Medical Devices and Healthcare Products, 3rd Edition, Taylor & Francis Group, 2021
REFERENCES:
1. Reliable Design of Medical Devices, Second Edition by Richard Fries, CRC Press, 2006
2. Medical Device Quality Assurance and Regulatory Compliance by Richard C Fries, CRC Press, 1998.
3. Product Safety in the European Union by GaborCzitan, Attila Gutassy, Ralf Wilde, TUVRheinlandAkademia, 2008.