India
- Regulatory Authority:
Central Organization for the Control of Standards for Medicines
General Directorate of Health Services
Ministry of Health and Family Welfare
- Legislations:
Rules for Medical Devices
- Certificate validity period:
5 years
- Registration period:
6–8 months
- Language of labeling and documentation:
English
- Authorized Representative:
country resident
Regulatory process for medical devices in India:
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Registration and examination process:
The regulatory authority analyzes the medical products, conducts laboratory tests and makes a decision on further registration