What is Penalty for non-compliance with medical device rules?
Nexa Consultancy | Startup & Finance Glossary
The Medical Device Rules, 2017, govern the manufacturing, import, and sale of medical devices in India. Non-compliance with aspects like labeling, quality control, and post-market surveillance can lead to suspension of license, fines, and imprisonment.
Startup Example: A medical device startup fails to report an adverse event associated with its product to the authorities. This can lead to the cancellation of their manufacturing license.
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