Local Holder Representation
Local Holder and Authorized Representative Services
Independent in-country representation to hold type approvals, sanitary registrations, and producer obligations on your behalf, keeping your market access under your control.
The requirement
Many regulators will only grant an approval to a company that exists in their country.
Type approvals for radio and telecom equipment, sanitary registrations for health products, electrical safety certificates, and producer registrations for electronics and batteries frequently have to be held by a legal entity registered in the country. Foreign manufacturers can't apply directly. Someone local has to stand in front of the regulator, take legal responsibility for the product in that market, and receive the certificate.
The default answer is the distributor or importer, because they're there. That works until it doesn't. The distributor owns the certificate. If the relationship ends, if they underperform, if they want to renegotiate, or if they simply stop responding, your ability to sell in that market goes with them. Transferring a certificate is slow where it's possible and impossible where it's not. Manufacturers discover this at the worst moment, usually mid-launch or mid-dispute.
ORBIS Compliance provides local holder representation as an independent alternative. We act as the in-country holder or authorized representative for your approvals, registrations, and producer obligations. The certificate is tied to a party whose only interest is keeping your market access valid and under your control.
Who holds the certificate
Distributor as holder versus independent representation.
Distributor or importer holds it
What matters
ORBIS holds it for you
The approval belongs to your channel partner. Changing partners can mean reapplying.
CONTROL
The approval is held on your behalf and follows your instructions, independent of commercial relationships.
A second distributor needs a second approval, or depends on the first one's goodwill.
MULTIPLE CHANNELS
One approval, held independently, supports every importer you authorize.
Renewals, labeling changes, and regulator queries sit with someone whose main job is selling.
COMPLIANCE DUTIES
Regulatory professionals track renewals, changes, and authority correspondence as part of the service.
You find out about an expiry or a query when the shipment stops.
VISIBILITY
Status, dates, and correspondence are visible in ORBIS Intelligent Compliance.
What we hold
Representation across the approvals that require it
Radio and telecom type approvals
Holding national type approvals where the regulator requires a local applicant, including the label and marking obligations that come with them.
Sanitary and health registrations
Acting as registration holder for medical devices, cosmetics, and other health-regulated products, with the legal responsibilities the health authority assigns to that role.
Electrical and safety certificates
Local certificate holding where national safety schemes require an in-country party, coordinated with factory surveillance and renewals.
Producer and environmental obligations
Authorized representative appointments for WEEE, battery, and packaging producer responsibility in markets where a foreign producer must appoint one.
Importer of record coordination
Working alongside your logistics partners where an importer of record is needed for samples or commercial shipments, without giving up the approvals.
Regulator liaison
Receiving and responding to authority correspondence, inspections, and information requests as the party of record, with your knowledge and direction.
How it works with ORBIS
The holder and the certification team are the same relationship.
When ORBIS acts as your local holder, the representation is part of the same engagement that scopes the testing, files the type approval or sanitary registration, and tracks the renewal. There's no handoff between a certification vendor and a representation vendor. The people who know the product are the people the regulator talks to.
Each held approval is recorded in ORBIS Intelligent Compliance with its holder, validity, marking requirements, and renewal triggers. Authority correspondence is logged. When you want to add an importer, change a distributor, or update a product variant, the implications for each approval are clear before you act.
The arrangement is documented in an agreement that makes your ownership of the market access explicit. If you ever want to move the approval to your own local entity or another party, the path is defined in advance.
Questions
Local holder representation
Does the local holder take on legal liability for our product?
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The holder assumes the responsibilities the regulator assigns to that role, which vary by market and approval type. The agreement between ORBIS and you defines how those responsibilities, and the information and cooperation needed to meet them, are shared. We're transparent about what the role requires in each country before you appoint us.
Can we transfer approvals currently held by a distributor to ORBIS?
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In many markets, yes, through a transfer or re-registration process. In some, a new application is required. We assess each approval and market and tell you the realistic path and timeline before you make changes to your distribution.
Do we still need a distributor or importer?
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For commercial sales, usually yes. Local holder representation separates the regulatory role from the commercial one. Your distributors sell; ORBIS holds the approvals. That separation is the point.
Keep your certificates in your own hands.
Tell us the markets where you need a local holder and the approvals involved. We'll explain what the role requires in each country and how the arrangement protects your access.
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