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

- 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](https://nptel.ac.in/courses/127106136)
- Licence: [CC BY-NC-SA](https://nptel.ac.in/faq) (Non-commercial use only.)
- Syllabus: [at the source](https://nptel.ac.in/courses/127106136)
- Who can watch: Teens profiles and older (sources give no ratings; placed by Invisible Network from the source's own words)

## Lectures

1. [Courses Overview](https://invisiblenetwork.ai/learn/nptel/127106136/9d5e3172f71f) (Video)
2. [Medical device and in vitro diagnostics: Introduction & types of devices including combination devices](https://invisiblenetwork.ai/learn/nptel/127106136/1196c74907b8) (Video)
3. [Medical Device Rules, 2017: Implications on medical devices](https://invisiblenetwork.ai/learn/nptel/127106136/773a5d80bd45) (Video)
4. [Classification of medical devices](https://invisiblenetwork.ai/learn/nptel/127106136/2acb8677aa33) (Video)
5. [Labelling of medical devices and in vitro diagnostics](https://invisiblenetwork.ai/learn/nptel/127106136/09257228ea37) (Video)
6. [Standards of medical device, quality assurance & testing](https://invisiblenetwork.ai/learn/nptel/127106136/d61d6f1f04d2) (Video)
7. [Regulatory requirements of biocompatibility of medical devices and ISO 10993](https://invisiblenetwork.ai/learn/nptel/127106136/308cc3167ad1) (Video)
8. [Clinical investigation of medical devices, regulation of investigational medical devices](https://invisiblenetwork.ai/learn/nptel/127106136/0e9ff32df02c) (Video)
9. [Quality assurance and quality management system](https://invisiblenetwork.ai/learn/nptel/127106136/8ccc824e5b5c) (Video)
10. [How to obtain a licence to manufacture a medical device?](https://invisiblenetwork.ai/learn/nptel/127106136/3db6ef3fd24c) (Video)
11. [ISO 14971 (Medical devices: Application of risk management to medical devices)](https://invisiblenetwork.ai/learn/nptel/127106136/f185d00466ce) (Video)
12. [Inspection of medical device and IVD establishments](https://invisiblenetwork.ai/learn/nptel/127106136/622cc7b947a1) (Video)
13. [Import & export of medical devices and IVDs](https://invisiblenetwork.ai/learn/nptel/127106136/c2385b466f07) (Video)
14. [Medical device regulation: International practices](https://invisiblenetwork.ai/learn/nptel/127106136/72fac602596e) (Video)
15. [Live Session 17-03-2020](https://invisiblenetwork.ai/learn/nptel/127106136/9d5e3172f71f-2) (Video)