India Risk Classification for Dermatology and Plastic Surgery as a Medical Device
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Introduction – Dermatology and Plastic Surgery Equipment Classification in India
This article discusses the latest rules for Dermatology and Plastic Surgery equipment classification in India as per the Medical Device Rules 2017 in India. Indian healthcare regulators at the Central Drugs Standard Control Organization (CDSCO) have issued significant risk-based classification lists for all Dermatology and Plastic Surgery products. This is the latest updated CDSCO medical device rules in India (effective September 30, 2021), as per notification 29/Misc./03/2020-DC (147).
India is Updating Existing Risk-Based Classifications for Medical Devices
On January 6th, 2025, India’s CDSCO published a draft annexure revisiting the existing classification lists under notification number MED-16014(12)/1/2022-eoffice. There are no changes in the Dermatology and Plastic Surgery equipment classification as outlined in previous notifications.
Conclusion: Medical Device Compliance in India for Dermatology and Plastic Surgery Equipment
The above article is based on notifications MED-16014(12)/1/2022-eoffice and 29/Misc./03/2020-DC (147), which outlines the classification of all medical devices. The CDSCO medical device classification in India is provided as Appendix A, considering intended use, associated risks, and other device-specific parameters. The table above lists the general intended uses of each device; however, specific intended uses must be provided by manufacturers. The classification list is dynamic and subject to updates, and manufacturers must ensure that their devices are compliant? with the latest Updated CDSCO medical device rules in India.
To obtain Medical device registration in India, contact Morulaa. We at Morulaa can assist you in understanding the latest rules for Dermatology and Plastic Surgery as a Medical Device in India. To meet the compliance deadline and stay updated on medical device compliance in India contact us at [email protected].
Morulaa HealthTech Pvt. Ltd. , It's awesome to see such important updates on medical device classification! Understanding these regulations is key for everyone involved in healthcare. Thanks for sharing this info—it's super helpful! How do you think these changes will impact manufacturers and healthcare providers in India? ???? #MedicalDevices #HealthcareCompliance