The Central Drugs Standard Control Organization (CDSCO) on September 12, 2024, issued the Draft Guidelines on Good Clinical Practices.
The following has been stated namely: -
• It states updated regulations for the import, manufacture, and sale of medical devices in India, emphasizing compliance with new standards and quality control measures.
• It specifies detailed registration requirements for medical devices, including documentation and approval processes to ensure safety and efficacy before market entry.
• Stakeholders shall submit comments and suggestions within 30 days i.e., on or before October 12, 2024, by email at: [email protected].
Kindly refer to the attached document for draft guidelines.
[Notification no. - GCT-11/14/2024-eoffice]
