Regulatory Services

PC-PNDT Registration Consultancy for Medical Devices

Ensure Legal Compliance for Ultrasound and Imaging Devices under the PC-PNDT Act

What is PC-PNDT Registration?

The Pre-Conception and Pre-Natal Diagnostic Techniques (Prohibition of Sex Selection) Act, 1994 (PC-PNDT Act) is a critical legal requirement in India. It governs the use, registration, and monitoring of ultrasound and other pre-natal diagnostic equipment to prevent sex-selective practices.

All facilities and individuals intending to sell, install, or operate ultrasound or imaging equipment capable of pre-natal sex determination must be registered under the PC-PNDT Act with the appropriate State/ District Appropriate Authority.

Our consultancy helps medical device manufacturers, importers, clinics, and diagnostic centers comply with all legal formalities under this act — from registration to recordkeeping.

Our PC-PNDT Compliance Services

We offer comprehensive support to help you navigate the regulatory and documentation requirements of the PC-PNDT Act:

Facility Registration

  • Preparation and submission of Form A for registration with the Appropriate Authority
  • Guidance on documentation including facility layout, machine details, and employee records
  • Assistance with inspection readiness and follow-up

Device & Dealer Registration

  • Support for ultrasound machine registration (including portable and stationary units)
  • Compliance guidance for manufacturers, importers, and suppliers regarding machine declarations and sales records
  • Advice on legal obligations for equipment with prenatal diagnostic capabilities

Recordkeeping & Reporting

  • Training and templates for maintaining Form F, patient consent forms, and monthly reporting
  • Audit readiness and compliance tracking to avoid penalties and suspension

Renewal & Amendment Support

  • Assistance with registration renewals, transfer, or addition of equipment or staff
  • Managing updates due to relocation or change in ownership

Who Needs PC-PNDT Registration?

Contract Manufacturers & Suppliers

Hospitals, maternity homes, fertility clinics

Medical Device & IVD Manufacturers

Radiology and diagnostic centers

Distributors & Importers

Gynecology and ultrasound clinics

EU Authorized Representatives

Medical device manufacturers, importers, and dealers selling or distributing diagnostic ultrasound equipment

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