The diagnostics sector is rapidly growing due to increased disease burden and insurance coverage, but it is also highly regulated due to its technical and sensitive nature.
MedAegis enables diagnostic centers to operate with regulatory clarity, technical compliance, and legal security.
Licensing and regulatory approvals
Compliance with equipment and radiation safety standards
Documentation and reporting protocols
Quality assurance and accreditation alignment
Data protection and patient confidentiality systems
Medical Device
Rules, 2017
Atomic Energy
Act, 1962
Pre-Conception and
Pre-Natal Diagnostic
Techniques (PCPNDT)
Act, 1994
Clinical
Establishments
Act, 2010
Consumer
Protection Act,
2019
Legal Metrology
(Packaged
Commodity) Rules,
2011
Ensure proper equipment licensing and maintenance.
Adhere to radiation safety norms and regulatory standards.
Strict compliance with PCPNDT Act and record requirements.
Follow import conditions and performance evaluation norms.
Ensure shelf-life standards for diagnostic kits and reagents.
Stay updated with regulatory developments on essential diagnostics and pricing controls.
