Skip to main content
Medical Device Consultant.MY
CSDT · EU MDR Annex II/III · FDA 510(k) content

Build the technical file once. Spend it everywhere.

The dossier is where registrations are won or lost — and where export costs are decided years in advance. We prepare CSDT files for MDA and structure them so your CE and FDA submissions inherit the same core.

MDA registration service
01 MDA Registration02 GDPMD + Licensing03 ISO 13485 QMS04 MDSAP05 CE / FDA Export
Philosophy

Documentation is an asset, not paperwork

Most registration problems are documentation problems: a missing essential principles justification, labeling that contradicts the IFU, clinical evidence that does not match the intended use. And most export budget blowouts trace to the same root — a Malaysia-only dossier that has to be rebuilt from scratch for the EU or US.

We build the file the way an auditor reads it, and the way an exporter reuses it: a single engineering core (specifications, risk management, verification evidence, clinical evaluation) rendered into whatever format the target market requires — CSDT for MDA, Annex II/III documentation for EU MDR, and eSTAR-ready 510(k) content for the US FDA.

Deliverables

  • Document inventory and gap report against the target market's checklist
  • Full CSDT dossier compiled and formatted for CAB / MDA review
  • Essential principles conformity checklist with evidence mapping
  • Labeling and IFU review against Malaysian requirements
  • Risk management summary aligned with ISO 14971
  • Clinical evidence summary appropriate to device class
  • Export-ready structure notes for later CE / 510(k) reuse

Included in per-device registration fees; standalone and export files quoted after a document inventory (usually within two working days).

FAQ

Frequently asked questions

What goes into a CSDT dossier?
Device description and specifications, the essential principles conformity checklist, labeling and IFU, risk management summary, verification and validation evidence, and clinical evidence. The depth scales with device class — a Class C dossier is a materially bigger build than a Class A notification.
Can one technical file serve MDA, CE and FDA?
Not verbatim — each market has its own format — but the engineering core (design specs, risk file, test reports, clinical evaluation) is 70–80% shared. We structure that core once, then render it as CSDT for MDA, Annex II/III documentation for EU MDR, and 510(k) content for FDA. That reuse is where our clients save the most money.
Our manufacturer holds the documents — can you still build the file?
Yes. For importers and distributors we run document collection against the manufacturer directly, gap-check what arrives, and tell you early if something critical (say, biocompatibility testing) is missing — before the CAB or MDA finds out.
What does technical file preparation cost?
Dossier preparation is included in our all-inclusive per-device registration fees (RM2,500 Class A / RM6,000 Class B / RM9,800 Class C — CAB and MDA fees included); standalone or export files are quoted after a document inventory.

Send us your document list

A one-page inventory of what your manufacturer can provide is enough for us to gap-check it and quote the dossier build.

WhatsApp