Compliance & Import

Compliance is a document set, and an audit only asks for the documents it expects.

Twenty-three articles on regulatory practice, device testing and cross-border movement: standards, safety testing, import and export documentation and the records buyers are asked to produce.

  • 23 compliance and import articles
  • Standards and testing grouped
  • Import and export documents covered

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XODUS MEDICAL 40657 Pink Pad Air-Assist Standard + Headrest 40657 – Ne listed on the ALLWILL marketplace

Standards and testing

The difference between a type test and a test in service is the one auditors check most.

Four things that decide compliance & import

Each one is settled before the purchase order.

01

The right test standard

Electrical safety testing in service follows a different standard from the type test a manufacturer performs.

02

Records with date and method

Registration and conformity requirements differ by market and change.

03

A complete import document set

Electrical safety testing in service follows a different standard from the type test a manufacturer performs.

04

Destination rules checked first

Registration and conformity requirements differ by market and change.

Where to go next

Adjacent guides in the same set, each written to the same depth.

Device Comparisons

Part of the same guide set.

Open the guide →

Service & Repair

Part of the same guide set.

Open the guide →

Pre-Owned & Refurbishment

Part of the same guide set.

Open the guide →

Sourcing & Supply

Part of the same guide set.

Open the guide →

Questions about compliance & import

What is the difference between a type test and a service test?
A type test certifies a design for manufacture; a service test verifies the specific unit in use. They are different standards and different records.
What should an electrical safety test record contain?
Date, method, instrument, applied limits and the technician. Anything less is not defensible in an audit.
What documents does an imported device need?
Invoice, packing list, certificate of origin, end-user declaration where required, and decontamination records for a used device.
Does a CE mark mean the device is safe?
It means the manufacturer has declared conformity for the intended use in that market. It does not replace your own inspection or acceptance testing.
Who is responsible for a device placed on the EU market?
An economic operator carries the MDR obligations. Agree who that is before the shipment.

Send the requirement

Tell us the device or the decision and we will come back with the options that fit and the records that protect the purchase.

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