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Course12710613615 lectures

Regulatory requirements for medical devices including in vitro diagnostics in India (Version 2.0)

Prof. Aseem Sahu, Prof. Malay Mitra and Prof. Arun B. Ramteke · CDSCO Ministry of Health & Family Welfare Former DDC(I) CDSCO CDSA THSTI DBT

Start with lecture 1 At NPTEL

Lectures

Week 1

  1. Courses Overview Video
  2. Medical device and in vitro diagnostics: Introduction & types of devices including combination devices Video
  3. Medical Device Rules, 2017: Implications on medical devices Video
  4. Classification of medical devices Video
  5. Labelling of medical devices and in vitro diagnostics Video

Week 2

  1. Standards of medical device, quality assurance & testing Video
  2. Regulatory requirements of biocompatibility of medical devices and ISO 10993 Video
  3. Clinical investigation of medical devices, regulation of investigational medical devices Video

Week 3

  1. Quality assurance and quality management system Video
  2. How to obtain a licence to manufacture a medical device? Video
  3. ISO 14971 (Medical devices: Application of risk management to medical devices) Video

Week 4

  1. Inspection of medical device and IVD establishments Video
  2. Import & export of medical devices and IVDs Video
  3. Medical device regulation: International practices Video

Live Session

  1. Live Session 17-03-2020 Video

Syllabus and materials

At NPTEL, as the course publishes them.

Credits and licence

Institution
CDSCO Ministry of Health & Family Welfare Former DDC(I) CDSCO CDSA THSTI DBT
Department
Multidisciplinary
Taught by
Prof. Aseem Sahu, Prof. Malay Mitra, Prof. Arun B. Ramteke
Level
Undergraduate
Language
English
Subjects
Medicine and health
Source
NPTEL
Licence
CC BY-NC-SA, as NPTEL states it. Non-commercial use only. NPTEL's terms
Attribution
NPTEL states: "Distributed under Creative Commons Attribution-ShareAlike / CC BY - NC - SA", beside a BY-NC-SA badge. Coordinated by IIT Madras.
Who can watch
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