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PCPNDT & AERB Compliance for Ultrasound & X-Ray

PROBLEM STATEMENT

A medical device manufacturer producing ultrasound and X-Ray machines sought assistance in obtaining compliance with the PCPNDT Act for prenatal diagnostic devices and the AERB (Atomic Energy Regulatory Board) license for radiation-emitting equipment. These licenses are mandatory in addition to standard regulatory certifications, ensuring lawful operation and safety standards for devices used in prenatal diagnostics and radiology.

Our Approach

  • PCPNDT Compliance: 
    • Prepared and submitted documentation for PCPNDT registration, including technical details of the ultrasound equipment, intended use, and facility compliance with the act’s mandates.
    • Ensured adherence to the act’s guidelines to prevent misuse of gender detection capabilities and supported the setup of mandatory record-keeping systems.
  • AERB License Acquisition:
    • Assisted in obtaining the AERB license from the Department of Atomic Energy (DAE) by preparing detailed submissions for X-Ray machine compliance.
    • Ensured devices met safety standards for radiation exposure, shielding, and monitoring systems, and verified adherence to radiation protection protocols as per AERB guidelines.
  • End-to-End Coordination:
    • Acted as a liaison between the client, PCPNDT authorities, and AERB officials, addressing all queries during the review process.
    • Conducted mock inspections and audits to ensure facility and equipment readiness before official evaluations.

Outcome

The company successfully obtained both PCPNDT registration for ultrasound machines and the AERB license for their X-Ray equipment. These certifications allowed the manufacturer to launch their devices in the Indian market, fully compliant with safety and legal standards, ensuring lawful operation in prenatal diagnostics and radiology.

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