MEDICAL DEVICES / U.S. MARKET ENTRY

FDA Initial
Importer.

Regulatory support.
Before arrival.

Specialized U.S.-based regulatory support for medical device manufacturers.

DISCUSS INITIAL IMPORTER SUPPORT ↗

Role                                                             Prepare                                                        Compare                                                      Plan

01 / MEDICAL DEVICES

Understand
the role.

What is an Initial Importer?

An Initial Importer is a U.S.-based importer that furthers the marketing of a foreign manufacturer’s medical device
to the final seller or user without changing its packaging or labeling.

The role includes applicable FDA establishment registration, medical device reporting, corrections and removals,
and postmarket recordkeeping duties. This regulatory role goes beyond shipping, sales, or storage and does not
necessarily require physical handling of the goods.

By designating PCG, you engage a U.S.-based FDA regulatory firm that monitors compliance, supports FDA
communications, and assists with import and postmarket issues within the agreed scope. Manufacturer
responsibilities remain with the manufacturer.

FDA ROLE

Initial Importer

An FDA medical device importer role with applicable compliance, reporting, recordkeeping, and postmarket
duties. Physical handling of goods is not necessarily required.

CUSTOMS ROLE

Importer of Record

A customs designation responsible for entry declarations, duties, taxes, and applicable customs obligations
during the import process. This role is distinct from FDA Initial Importer duties.

02 / MEDICAL DEVICES

Prepare
the essentials.

Required Regulatory Services: PCG onboarding requirements, subject to your device and
establishment activities.

01 / REQUIRED

Establishment Registration

02 / REQUIRED

U.S. Agent Designation

03 / REQUIRED

Device Listing

04 / REQUIRED

Initial Importer

05 / REQUIRED

FDA Label Compliance Review

06 / REQUIRED

GUDID & UDI Submission (if applicable)

Label Compliance Review Service

PCG reviews product labeling, label claims, and applicable mandatory FDA labeling elements before U.S. import
to assess compliance and reduce regulatory risk.

Label review is required for PCG Initial Importer onboarding to assess labeling compliance and reduce import
and postmarket risk. The Initial Importer assumes applicable regulatory duties for devices entering the United
States. Manufacturer obligations remain with the manufacturer.

03 / MEDICAL DEVICES

Compare
the support.

Why an Initial Importer, not a distributor or warehouse?

SERVICE MODEL

PCG Initial Importer

Dedicated regulatory duties, compliance monitoring, FDA communication, and postmarket support within the
agreed service scope.

SERVICE MODEL

Distributor

Primarily focused on sales. Regulatory capabilities and contracted duties vary.

SERVICE MODEL

Warehouse

Primarily focused on storage. Regulatory capabilities and contracted duties vary.

Initial Importer Service
Comparison Chart

01 / FEATURE

Initial importer designation

PCG — Provided

COMPETITOR A — Provided

COMPETITOR B — Provided

02 / FEATURE

U.S. agent

PCG — Provided

COMPETITOR A — Provided

COMPETITOR B — Provided

03 / FEATURE

Import clearance & border support

PCG — FDA communication support

COMPETITOR A — Not publicly indicated

COMPETITOR B — Not publicly indicated

04 / FEATURE

Postmarket management

Complaints, recalls, MDRs, corrections & removals

PCG — Reporting & record support

COMPETITOR A — Limited disclosed scope

COMPETITOR B — Regulations mentioned; scope unclear

05 / FEATURE

Recordkeeping & regulatory alignment

21 CFR 803 / 806 / 807 / 820 / 821

PCG — Applicable CFR support

COMPETITOR A — Part 807 support disclosed

COMPETITOR B — Scope unclear

06 / FEATURE

FDA inspection support

PCG — Inspection readiness support

COMPETITOR A — Qualification not verified

COMPETITOR B — Qualification not verified

07 / FEATURE

Visible expertise & industry presence

PCG — Established regulatory practice

COMPETITOR A — Limited public information

COMPETITOR B — Limited public information

08 / FEATURE

FDA regulatory liaison

PCG — Provided

COMPETITOR A — Not publicly indicated

COMPETITOR B — Not publicly indicated

Comparison reflects PCG’s published assessment. Unverified or undisclosed services are not assumed unavailable.

04 / MEDICAL DEVICES

Plan before
you ship.

Cost Comparison: PCG vs. Self-Importing

SELF-IMPORTING

$13,785

FY2027 FDA establishment registration fee, where applicable. Plus registration service and U.S. agent fees. You
manage importer compliance and inspection response. Noncompliance can lead to FDA enforcement.

PCG INITIAL IMPORTER

Tailored quote

Your quote depends on the number of product codes and the manufacturers or facilities represented.

PCG or its designated affiliate performs contracted importer duties and provides guidance. Inspection
engagements are quoted separately. Manufacturer registration fees and obligations remain separate.

Proactive compliance

Arrange compliant importing before shipment. A last-minute Initial Importer designation does not guarantee FDA
acceptance or shipment release. FDA may refuse entry; export or destruction may be required under applicable
procedures.

PCG can assist when noncompliance is identified, but the FDA inspector retains discretion.

Prepare before
arrival.

Discuss your device, regulatory requirements, and initial importer arrangement.

DISCUSS INITIAL IMPORTER SUPPORT ↗