Build the technical file once. Spend it everywhere.

The document core behind every approval

A technical file is the evidence dossier that proves a device is safe and performs as intended. In Malaysia it takes the form of the CSDT — the Common Submission Dossier Template, the ASEAN-harmonised format the Medical Device Authority (MDA) and its conformity assessment bodies (CABs) require for registration under the Medical Device Act 2012 (Act 737). It is submitted through the MDA's MeDC@St system, and it is what the CAB and the MDA actually read when they decide whether your device reaches the Malaysian market.

At its heart the CSDT demonstrates essential-principles conformity — that the device meets Malaysia's Essential Principles of Safety and Performance. The same engineering evidence answers the EU's General Safety and Performance Requirements (GSPR, EU MDR Annex I) and the substantial-equivalence argument the US FDA expects, which is why the file you build for Malaysia is the foundation for every export market that follows.

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 and validation evidence, clinical evaluation — rendered into whatever format the target market requires. That is CSDT for the MDA, Annex II/III documentation for EU MDR, and eSTAR-ready 510(k) content for the US FDA — all sitting on the quality system that holds it together, ISO 13485.

From document list to a submission-ready dossier

1. Document inventory — we list exactly what the target market's checklist requires and what your manufacturer can actually supply.
2. Gap check — we compare the two and flag missing evidence (biocompatibility, EMC, clinical) early, so the shortfall surfaces before the CAB or MDA finds it.
3. Dossier build — the CSDT is compiled and formatted for CAB / MDA review, with the essential-principles checklist mapped line-by-line to the supporting evidence.
4. Export structuring — the same core is organised so your later CE (Annex II/III) and FDA 510(k) submissions inherit it instead of starting again.

What we deliver

• 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 with registration, or quoted standalone

When we register your device with the MDA, the CSDT is built as part of that engagement — its cost is already inside the all-inclusive per-device fee: RM6,000 for a Class B device and RM9,800 for Class C, with CAB and MDA fees included. You are not billed twice for the dossier.

Need the technical file on its own — for an export submission, a new conformity assessment body, or to hand to your own RA team? Standalone and export-only files are quoted after a short document inventory (usually within two working days). See the full pricing schedule.

Registration programs that include the CSDT can be spread over a payment plan from RM1,500/month — same scope, same timeline. See pricing for the full three-step schedule.

Named regulatory people, not a document mill

The technical file is where an inexperienced consultant is exposed — reviewers can tell a copy-pasted dossier from one built by people who understand the device. You work with named regulators who run device registrations themselves, with LinkedIn profiles you can check.