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 Solution:
- 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.
