PC-PNDT Registration & CertificateFor Ultrasound & Imaging Medical Devices (Form A & B)
End-to-end statutory licensing, Form A filing, Appropriate Authority liaison, and Form B certificate acquisition for manufacturers, importers, dealers, and technicians of ultrasound and imaging machinery in India.
Apply for PC-PNDT Registration
Connect with our regulatory consultants for fast-track Form A compilation and Form B grant.
Understanding the PC-PNDT Regulatory Framework
Under the Pre-Conception and Pre-Natal Diagnostic Techniques (Prohibition of Sex Selection) Act, 1994, strict regulations govern the sale, import, distribution, manufacturing, and maintenance of ultrasound and imaging machines in India.
Under Section 3B of the Act, no organization or individual may sell, distribute, import, or supply ultrasound or imaging equipment to any entity unless both parties hold valid PC-PNDT registration certificates. Every stakeholder must apply via Form A to the designated Appropriate Authority (Directorate of Family Welfare) to secure their Form B Certificate of Registration.
Key Registration Parameters
Who Must Register Under PC-PNDT?
Ultrasound & Imaging Importers
Foreign OEMs and Indian distributors importing diagnostic ultrasound, echocardiography, or fetal imaging apparatus into India.
Medical Device Manufacturers
Domestic medical equipment manufacturers assembling, calibrating, and selling ultrasound and diagnostic imaging scanners.
Dealers, Retailers & Stockists
Channel partners, stockists, and traders engaged in the commercial warehousing, sale, leasing, and distribution of diagnostic equipment.
Service Technicians & Buyback Entities
Third-party biomedical service organizations involved in buyback, refurbishment, maintenance, recalibration, and repair of imaging machinery.
Our PC-PNDT Regulatory Deliverables
NKB Regovanta manages every phase of PC-PNDT compliance, from initial documentation compilation to formal certificate delivery and post-grant transaction governance.
Form A Application Preparation
Comprehensive drafting and verification of statutory Form A filings, corporate ownership declarations, and machinery specification catalogues.
Appropriate Authority Liaison
Liaison with State & District Appropriate Authorities and Advisory Committees under the Directorate of Family Welfare.
Form B Registration Grant
Securing the official Form B Certificate of Registration, valid for 5 years across defined operational territories.
Lifecycle Record & Inspection Advisory
Ongoing support for customer intimation logs, installation registers, biannual returns, and statutory 2-year audit readiness.
Mandatory Documents for Form A Registration
The Appropriate Authority requires specific legal, corporate, and technical proofs before initiating advisory committee evaluation.
Corporate & Ownership Proofs
- Entity Ownership Proof: Certificate of Incorporation, Partnership Deed, or Proprietorship proof.
- Constitutional Documents: Memorandum & Articles of Association (MOA/AOA) with director profiles.
- Premises Possession: Valid registered lease agreement or property ownership title for warehousing/office.
Machinery & Operational Evidence
- Product Specification Dossier: Detailed technical brochures, model numbers, and probe configurations.
- Scope of Activity Declaration: Precise operational charter (import, manufacturing, repair, buyback, or distribution).
- Authorized Signatory Affidavit: Duly signed and stamped undertaking under the PC-PNDT Act.
Statutory 2-Year Record Retention Mandate
Under the PC-PNDT Act, all sales registers, serial number logs, customer clinic registration verifications, consent affidavits, and transaction declarations must be retained in an inspection-ready state for a minimum period of 2 years.
NKB Regovanta provides standardized record-keeping templates and internal audit protocols to ensure your organization is completely shielded against regulatory non-compliance.
Key Compliance Checklist
- Never sell or transfer imaging machinery to an unregistered doctor or facility.
- Submit monthly machine supply intimations to the District Appropriate Authority.
- Maintain comprehensive engineer service and buyback trace logs.
Frequently Asked Questions on PC-PNDT Registration
Common questions regarding ultrasound machinery licensing, Form A filing, and statutory compliance in India.
Need PC-PNDT Form A & Form B licensing support for your imaging equipment?
Speak with NKB Regovanta’s medical device licensing advisors to fast-track your Appropriate Authority submission.