GRZAN United States Medical Device Registration Services

1. Key takeaways

GRZAN’s United States medical device registration service covers six nodes: classification determination and product code confirmation, establishment registration and device listing, designation of the US Agent, preparation and submission of premarket dossiers (510(k), De Novo, PMA, HDE), import customs clearance support, and post-market compliance management. For the United States market, GRZAN’s registration team delivers the work in coordination with its local compliance partner in the United States. The six-node design mirrors the statutory obligation structure, so a client engaging the service can see, node by node, which legal duty each workstream satisfies and where each record will be produced. It also fixes accountability: each node has a defined owner on the GRZAN side, and the handoffs between nodes are documented rather than informal.

2. Legal basis

The services described here map onto the following provisions and FDA documents, in force as of the verification date noted at the end of this page.

3. Expert insights

Insight one: GRZAN’s United States delivery uses a coordination model with the local compliance partner.

GRZAN maintains its own entities in six markets: Singapore, Malaysia, Thailand, Indonesia, Vietnam, and the Philippines, and can serve directly as the local license holder, importer, and authorized representative in those markets. In the United States, the US Agent must reside or maintain a place of business within the United States under 21 CFR 807.40, so we complete the agent designation through our local compliance partner in the United States, while GRZAN’s registration team carries out all dossier and project management work. The practical estimate for clients is that the local presence requirement is satisfied by the partner, while the substantive file work stays under GRZAN’s direct control. This split follows the shape of the regulation: the law requires a domestic presence for the agent role, but it places the filing and reporting duties on the manufacturer, where GRZAN’s project management operates.

Insight two: the service chain is designed around six nodes, corresponding one to one with the statutory obligations.

The six nodes correspond to the obligation structure of the FD&C Act and 21 CFR: classification determination corresponds to Section 513; registration and listing correspond to Section 510 and 21 CFR 807; the US Agent corresponds to 21 CFR 807.40; premarket dossiers correspond to Section 510(k), Section 513(f)(2), Section 515, and Section 520(m); import customs clearance corresponds to Section 801; and post-market compliance corresponds to 21 CFR Parts 803, 806, 821, and 830. This one-to-one mapping is what keeps the engagement auditable: every deliverable can be traced back to a provision, pending verification of each node’s current requirements at project start. It also simplifies scope discussions, because a client asking what a given fee buys can be shown the provision it serves.

Insight three: fees and timelines are not offered as commitments.

MDUFA fees are adjusted by fiscal year (for FY2026 the 510(k) fee is USD 26,067, and for FY2027 USD 28,653), and review timelines are affected by requests for additional information. What we provide in project documents is the fiscal-year fee rate and the statutory timeframes; we do not provide approval commitments or guaranteed clearance dates. Budget planning should therefore carry the fee at the fiscal-year figure and treat review duration as a range, pending verification of the current notice, with the project schedule updated whenever FDA issues new rate notices.

In our practical estimate, any service offer that promises a clearance date in this space is promising something outside its control, and clients should weigh such offers accordingly.

Insight four: after the QMSR takes effect, system remediation is a must-do item for most Chinese companies.

Under 21 CFR 820 (effective 2026-02-02, incorporating ISO 13485:2016 by reference), a Chinese company that already holds an ISO 13485:2016 certificate still needs to perform a QMSR gap analysis; a company that only has legacy QSR system documentation must reorganize it according to the clause structure of ISO 13485:2016. Holding the certificate demonstrates alignment with the standard, but the regulatory mapping and the documentation updates remain, and both belong on the project plan alongside the submission work rather than after it. In our practical estimate, the gap analysis is the fastest of the two tasks when the certificate is current, and the full reorganization is required when the documentation still reflects the legacy QSR structure.

4. Practical recommendations

• At the project initiation stage, complete the classification determination first and issue the classification determination and product code confirmation document as the input for all subsequent work.
• Complete registration, listing, and the US Agent designation before signing the first United States order.
• Prepare the dossier on the current version of eSTAR (7.1) from the very beginning.
• Advance system remediation and dossier preparation in parallel, not in series.
• Bring the five post-market lines (annual registration, listing maintenance, MDR, UDI and GUDID, corrections and removals) live before the first shipment.

5. Verification checklist

• □ The classification determination and product code confirmation document has been completed
• □ Establishment registration and device listing have been completed
• □ The US Agent has been designated and written consent obtained
• □ The premarket dossier has been prepared on eSTAR 7.1
• □ The system has completed gap remediation according to the QMSR (ISO 13485:2016)
• □ The five post-market lines are live
• □ The import clearance document package (product code, entry number, Form FDA 2877) is complete

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, US Agent and local testing support for the United States market. Our team manages FDA establishment registration and listing, 510(k)/De Novo/PMA submissions, and supports post-market reporting obligations. Business enquiries: info@grzanglobal.com