01
Distributor and importer appointment
Territory, exclusivity, minimum purchase, and the party named as importer of record. The Matter Pack settles who carries the regulatory duties before you sign, rather than after a shipment is held.
The industry
Devices cross borders faster than their paperwork.
A device cleared at home still needs a local licence holder, a registered importer and a distribution contract that survives an audit. Each one is a separate agreement under the destination country's law, and any one of them can hold a shipment at the border.
Orbid turns that paperwork into a Matter Pack built from fixed-fee modules before anyone bills an hour. Licensed local counsel in the destination market reviews the pack, so the registration file and the commercial contract tell the same story.
- EU MDR
- Article 13 places named obligations on the importer, not only on the manufacturer.
- Thailand
- The product licence sits with the Thai licence holder, so the registration follows whoever holds it.
- ASEAN
- The AMDD harmonises the dossier format. It does not harmonise the approval.
What we scope
Four things that decide whether the product ships.
02
Licence holder and registration control
If the distributor holds the registration, changing distributor means registering the product again. The Matter Pack fixes who owns the dossier, what happens on termination, and the transfer wording the regulator will accept.
03
Quality and supply agreements
Specifications, incoming inspection, nonconformance, recall roles and complaint handling. The quality agreement has to match the registration file, so counsel reviews both against one set of facts.
04
Clinical work and patient data
Investigator and CRO agreements, plus the transfer terms for patient and device data. A trial that runs across the corridor can sit under the GDPR and a local data law at the same time.
Contract clusters we name first
Channel
Distributor and importer appointment — territory, exclusivity, and who is importer of record.
Regulatory
Licence-holder and registration control, so a change of distributor does not force a new filing.
Procurement
Quality and supply paper that has to match the registration file.
Corridors that show up
- 01China → Thailand. The product licence sits with the Thai licence holder. Live corridor: licensed local review is available.
- 02China → Germany. Importer duties under EU MDR Article 13 sit on a named party, not only the manufacturer.
- 03ASEAN listed. The AMDD harmonises the dossier format. It does not harmonise the approval. Scope is accepted; a lawyer standing by is not promised.
Healthcare matters we have scoped
Anonymised corridor work. Demo data for internal review.
China → Thailand
Orthopaedic implant distributor appointment
Exclusive distribution plus a licence-holder agreement that keeps the product registration transferable.
Get my priceGermany → Vietnam
IVD analyser supply and quality agreement
Supply terms and a quality agreement written against the same registration file.
Get my priceSingapore → Indonesia
Patient-monitoring clinical evaluation
Investigator and CRO terms, with the data transfer settled before enrolment opened.
Get my priceQuestions
Does the distributor hold the registration?
Often yes in Thailand. Name that as a fact in the Matter Pack before hours start — changing the holder later can mean filing again.
Is a quality agreement in the same Matter Pack as distribution?
Only if you name it as a defined set. An unnamed quality neighbour is a change order.
Does Orbid advise on MDR classification?
No. Licensed local counsel reviews the named facts. Orbid scopes. Orbid is not a law firm.
Bring us a deal.
A contract, a distributor, a supplier, a first hire or a new market.
Orbid will tell you what it takes and what it costs.