Learn · Regulatory requirements for medical devices including in vitro diagnostics in India (Version 2.0)
Lecture 1 of 15Week 1
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Prof. Aseem Sahu, Prof. Malay Mitra and Prof. Arun B. Ramteke · CDSCO Ministry of Health & Family Welfare Former DDC(I) CDSCO CDSA THSTI DBT
Credits and licence
- From
- Regulatory requirements for medical devices including in vitro diagnostics in India (Version 2.0), CDSCO Ministry of Health & Family Welfare Former DDC(I) CDSCO CDSA THSTI DBT (at NPTEL)
- Licence
- CC BY-NC-SA, as NPTEL states it. Non-commercial use only.
- 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
- Teens profiles and older. How courses are placed
All the lectures
- Courses Overview
- Medical device and in vitro diagnostics: Introduction & types of devices including combination devices
- Medical Device Rules, 2017: Implications on medical devices
- Classification of medical devices
- Labelling of medical devices and in vitro diagnostics
- Standards of medical device, quality assurance & testing
- Regulatory requirements of biocompatibility of medical devices and ISO 10993
- Clinical investigation of medical devices, regulation of investigational medical devices
- Quality assurance and quality management system
- How to obtain a licence to manufacture a medical device?
- ISO 14971 (Medical devices: Application of risk management to medical devices)
- Inspection of medical device and IVD establishments
- Import & export of medical devices and IVDs
- Medical device regulation: International practices
- Live Session 17-03-2020