International Sponsor Program
U.S. Agent, 510(k), QMSR, and establishment registration support for Indian device manufacturers entering the U.S. market.
India's Central Drugs Standard Control Organisation (CDSCO) regulates medical devices domestically under the Medical Devices Rules. For manufacturers already meeting CDSCO's quality and licensing requirements, the U.S. pathway is a separate, additional registration and submission process — FDA does not accept CDSCO approval as a substitute for its own review.
A common structure for Indian device manufacturers is contract manufacturing for a U.S.-based brand or distributor, which means the U.S. entity receiving the device commercially often takes on initial importer obligations under QMSR — separate from, and in addition to, the Indian manufacturer's own quality system responsibilities. Getting this importer relationship right at the outset avoids a compliance gap that's expensive to unwind later.
Indian manufacturers most often pursue 510(k) clearance for surgical and diagnostic instruments, consumables, infusion and IV administration sets, and orthopedic implants and instrumentation — device categories where India has a well-established manufacturing base and where predicate devices are typically available for a standard substantial equivalence comparison.
Before commercial distribution in the U.S., an Indian establishment needs FDA establishment registration and device listing, plus a designated U.S. Agent under 21 CFR 807.40 to serve as FDA's point of contact. ADB handles registration, listing, and the U.S. Agent role as one coordinated engagement.
India Standard Time runs roughly 9.5-10.5 hours ahead of U.S. Eastern Time, which puts an Indian team's evening into a U.S. Eastern morning — a workable scheduled-call window, with the client portal carrying written updates the rest of the day.
Indian manufacturers most often bring ADB submissions for general surgical and diagnostic instruments, single-use consumables and infusion/IV sets, and orthopedic implants and instrumentation — these are areas ADB has supported or is equipped to support, not an exhaustive or exclusive list.
Common Questions
CDSCO approval and supporting technical data can inform the U.S. submission strategy, but FDA conducts an independent review — CDSCO licensing is not accepted as a substitute for FDA’s own predicate comparison and clearance decision.
Both parties carry distinct obligations: the Indian manufacturer’s own quality system, and separately, initial importer obligations under QMSR for the U.S. entity that first takes commercial possession of the device in the United States. Neither obligation substitutes for the other.
Most reusable or single-use surgical instruments from Indian manufacturers pursue a Traditional 510(k) built around a predicate device with matching intended use and comparable technology, supported by reprocessing validation (for reusable devices) or shelf-life and sterilization validation (for single-use devices).
Yes — 21 CFR 807.40 prohibits the U.S. importer from simultaneously serving as the U.S. Agent, so a sales distributor relationship does not satisfy the U.S. Agent requirement. A separately designated U.S. Agent is required before FDA establishment registration can complete.
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30 minutes to assess your U.S. Agent, submission, or IDE sponsor needs.