PCPNDT Act Compliance in India
The Pre-Conception and Pre-Natal Diagnostic Techniques (PCPNDT) Act, 1994, regulates the use of diagnostic techniques capable of determining the sex of a foetus. All ultrasound machines, imaging equipment, and related diagnostic devices must be registered under this Act. The law is strictly enforced to prevent sex-selective practices, with severe penalties for non-compliance.
For medical device manufacturers and importers — particularly those dealing with ultrasound, imaging, and diagnostic equipment — PCPNDT compliance is a critical regulatory requirement. ACPL provides expert guidance to ensure your products and operations meet all PCPNDT Act requirements.
Our Services
- Registration of ultrasound and imaging equipment under the PCPNDT Act
- PCPNDT Act compliance advisory for device manufacturers and importers
- Documentation, forms, and filing support for equipment registration
- Compliance audit preparation and mock inspections
- Regulatory liaison with Appropriate Authorities at state and district levels
- Record-keeping and reporting compliance systems
- Staff training on PCPNDT Act obligations
Key Compliance Requirements
- Equipment registration — All ultrasound machines must be registered with the Appropriate Authority within the jurisdiction of use
- Form F compliance — Mandatory patient consent form for every diagnostic procedure
- Record maintenance — Detailed records of all procedures must be maintained for two years
- Signage requirements — Clinics must display mandated notices about the prohibition of sex determination
- Sale restrictions — Equipment can only be sold to registered facilities with qualified operators
Penalties for Non-Compliance
Violations of the PCPNDT Act carry severe consequences: imprisonment of up to five years, fines up to Rs. 1 lakh for first offence, suspension of medical registration, and seizure of equipment. Repeat offences carry enhanced penalties.
Related Services
- CDSCO Registration — Medical device registration for imaging and diagnostic equipment
- Materiovigilance — Post-market safety monitoring for diagnostic devices
- BIS Certification — Product standards applicable to electronic medical devices
- India Entry Strategy — Market entry for international diagnostic equipment companies