India Medical Device and IVD Regulatory Update: September 2018
Regulatory Updates | Medical Devices
EMERGO SUMMARY OF KEY POINTS:
- India’s Central Drugs Standard Control Organization (CDSCO) plans to rename itself.
- CDSCO has also published new guidance documents on Medical Device Regulations, 2017 compliance and performance evaluations for IVDs.
Indian regulators have recently announced several updates regarding their medical device and IVD oversight programs.
First, CDSCO plans to rename itself to more accurately convey its mission. No new name has yet been announced, but potential names under consideration include the National Drug Authority (NDA) and Central Drug Authority (CDA).
New medical device guidance
Second, the Indian Pharmacopoeia Commission (IPC) has published new draft guidance on medical device registration and regulatory compliance to the country’s Medical Device Rules, 2017. The guidance is intended to serve as a reference manual for issues including device classification, quality management, registration and post-market vigilance.
New IVD guidance
Third, Indian regulators have issued new guidance on performance evaluation of IVD devices after changing performance evaluation report (PER) requirements. The guidance identifies types of IVDs that require reports from approved device testing laboratories, and provides a list of such laboratories accredited to conduct IVD performance evaluations.
Related Indian medical device regulatory resources from Emergo:
- India CDSCO medical device registration and approval consulting
- India medical device regulatory strategy report
- Whitepaper: India’s Medical Device Rules, 2017