An independent, FDA-recognized 3P510k Review Organization under the U.S. FDA CDRH 510(k) Third Party Review Program.
Check Eligibility

About Global Third Party Review.

An independent medical-device review organization built to deliver Third Party 510(k) review from India, to the standard FDA recognition requires.

About Global Third Party Review

Global Third Party Review Private Limited is an independent medical-device regulatory review organization recognized under the U.S. FDA CDRH 510(k) Third Party Review Program. Within its recognized scope, GTPR conducts the primary review of eligible Class I and Class II 510(k) submissions.

Why GTPR was established. GTPR was established to build independent Third Party 510(k) review capability from India for global medical-device manufacturers — providing rigorous, impartial regulatory review to the standard FDA recognition requires.

Continuity of the Review Organization

GTPR's review capability has a documented lineage. The timeline below reflects the transition to GTPR as the independent review entity; exact dates and references are those in the FDA record.

  1. Origin

    FDA recognition of the review capability under SMO India

    The Third Party 510(k) review capability was originally established and FDA-recognized under SMO India Clinical Research Pvt. Ltd.

  2. Establishment

    Formation of GTPR as the independent review entity

    Global Third Party Review Private Limited was established as the dedicated, independent Third Party Review Organization.

  3. Transition

    FDA-approved transition of recognition to GTPR

    Recognition was transitioned to GTPR under FDA's process. GTPR's current recognition and recognized scope are verifiable on FDA.gov.

GTPR does not claim to have held FDA recognition prior to the transition. Recognition dates and references reflect the FDA record; confirm current status on the FDA list of recognized organizations .

Hyderabad — our operating base

GTPR is based in Hyderabad, a center of India's medical-technology and regulatory ecosystem, positioning the organization to serve manufacturers seeking review under the FDA Third Party pathway.

Review organization structure

Regulatory Review Unit
Primary technical & regulatory review.
Quality Assurance
Independent quality oversight.
Technical Reviewers
Subject-matter evaluation by device area.
Program Operations
Intake, administration & records.

Mission

To provide rigorous, independent and efficient medical-device regulatory review while maintaining the technical standards, impartiality and integrity required of an FDA-recognized Third Party Review Organization.

Work with an independent, FDA-recognized reviewer.

Start with an eligibility determination.

Check Device Eligibility