EC Registration Support
As per the new regulations under rule 122 DD, CDSCO has made it mandatory for all Ethics committee to get registered with CDSCO so as to get authority to review and accord its approval to clinical trial protocol. CliniExperts can assist in registration process of various institutional and independent Ethics Committee all across India. Our experts team will guide you to accomplish the registration process with utmost ease.
Recent Posts
AI/ML-Based Medical Devices — Emerging Regulatory Questions
Traditional Medical Device regulation assumes a fixed product: what’s approved is what ships, indefinitely, until a formal change is filed and reviewed. Adaptive AI and machine learning algorithms b..
Post-Market Surveillance for Cosmetics in India: What CDSCO Expects After Launch
Getting a Cosmetic product registered and onto shelves in India is only half the job. Once a product is in the market, the Cosmetics Rules, 2020 place ongoing duties on manufacturers and Importers to ..
Software as a Medical Device (SaMD) - India’s Regulatory Stance
Although software intended for Medical purposes has been regulated in India since the implementation of MDR, 2017 Rules. CDSCO’s Guidance Document on Medical Device Software (Doc No. CDSCO/MD/GD..
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