A UK MHRA Certificate of Free Sale (CFS) for C-reactive protein test kits identifies registered CRP assays selected for overseas documentation. Its schedule connects the listed kits to the manufacturer’s assay descriptions, specimen requirements, instrument compatibility and conformity records.
The issued certificate can then be prepared for overseas use through verification, professional certification, an apostille and any required embassy legalisation.
Product category and MHRA registration: C-Reactive Protein Test Kits
CRP tests intended to detect or measure C-reactive protein in human specimens are IVD medical devices. Product ranges may include laboratory reagent kits, reader-based cartridges and other rapid test formats. The manufacturer defines the specimen types, intended users, operating setting and result format for each assay. A particular analytical range or sensitivity claim belongs to that product’s documented intended purpose.
The MHRA’s Device Online Registration System, or DORS, holds manufacturer, device and product records. Registration includes the relevant conformity information, such as CE or UKCA documentation, together with the details identifying the products. For manufacturers based outside the UK, a UK Responsible Person represents the manufacturer for the Great Britain registration process.
The MHRA’s medical device registration guidance explains the registration framework. The April 2026 reference guide describes how these records are entered and maintained in the online system.
For Great Britain, the manufacturer’s records sit within the UK medical device framework. A CFS order is submitted by an eligible UK-based manufacturer or UK Responsible Person, using registered products and the relevant CE or UKCA conformity evidence.
Documents and product information
The registration process brings together information about the manufacturer, the product and its conformity documentation. The main records include:
- Manufacturer details: the legal manufacturer’s name, registered address and contact information.
- UK Responsible Person documentation: representative details and the designation agreement, where applicable.
- Product details: assay name, catalogue reference, legal manufacturer, test format, intended specimen and supplied kit contents. Labels, instructions, conformity documents and technical records describe the CRP measurement or detection method, performance characteristics and any reported measurement range. Storage, stability and expiry relate to the supplied presentation. Instrument, calibrator and control references identify the supported configuration where relevant.
- Registration identifiers: the GMDN code and term, with Basic UDI-DI and UDI-DI where applicable.
- Conformity documentation: the Declaration of Conformity and applicable conformity assessment certificates, including their references, validity and product schedules.
- Supporting product records: labels, instructions for use and the technical and performance documentation held by the manufacturer.
The online registration links the relevant conformity documents to the device record and identifies the individual products beneath it. The wider technical documentation supports the manufacturer’s compliance records; it is not a separate standard upload package for each CFS order.
From MHRA registration to an electronic CFS
- Accepted registration establishes the manufacturer, device and individual product records in DORS. Current conformity documents are linked to the relevant entries.
- The applicant selects the products marked CFS Ready and reviews the certificate and schedule preview. Model names and catalogue references come from the registered product data.
- After the order is submitted and paid for, the MHRA issues an electronically signed PDF. The complete certificate and every schedule page form the document set for subsequent verification and legalisation.
IVDs registered for performance evaluation cannot be included in CFS orders.
The MHRA CFS Reference Guide describes these stages. The published CFS service information gives an issuance aim of ten working days, with longer processing possible during busy periods.
Product coverage in the CFS schedule
CRP products sharing a commercial brand can differ in specimen compatibility, reagent presentation, assay range or reading system. Catalogue references connect the exported kit to its registered description. A separately marketed analyser, calibration material or control may have its own product identity even when used with the assay. The CFS schedule identifies selected registered entries rather than every product used in the testing workflow. Complete schedule pages and assay specifications explain the kit presentations included in the certificate and distinguish them from other CRP products in the range.
Direct verification of the CFS with the MHRA
For an overseas submission, the authenticity of the issued certificate is an important part of document preparation. Ginkgo Advisory can arrange for a solicitor to seek direct confirmation of the CFS with the MHRA and review the certificate together with its schedule.
Solicitor certification and express UK FCDO apostille
Where the solicitor-certified route is accepted for the intended submission, Ginkgo Advisory can arrange solicitor certification followed by a UK FCDO paper apostille. The certification format is matched to the receiving authority’s requirements. MHRA’s published guidance describes a notarial route, and notarisation is arranged where that route is required.
Our express UK FCDO apostille service normally takes two working days once verification and the required certification are complete and the document is accepted for submission. The apostille stage has its own timetable, separate from MHRA certificate issuance, verification responses, any embassy processing and delivery. Further FCDO checks can affect completion.
Embassy legalisation for Egypt, the UAE, Kuwait and Qatar
Ginkgo Advisory can arrange embassy legalisation where required, bringing the verification, certification, apostille and relevant embassy submission into one coordinated service. The destination and intended use determine the required document format and any additional stages.
Preparing an issued MHRA CFS for overseas use
For a quotation, the starting documents are the MHRA-issued electronic PDF and all accompanying schedule pages. The issuance email, destination country, receiving authority’s instructions and required completion date help establish the appropriate preparation and delivery arrangements.
Contact Ginkgo Advisory with the issued CFS for a quotation covering direct MHRA verification, solicitor certification where accepted, express FCDO apostille and any required embassy legalisation.
Product questions
Does one CRP kit CFS include every assay range sold by the manufacturer?
Each assay description identifies its intended purpose, performance claims and catalogue presentation. Different assay ranges or sensitivity claims remain linked to their own documented products. The selected registered entries and issued schedule establish which CRP kits are represented in the certificate set.