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Technical File Requirements

Overview​

The technical file (technical documentation) is the compilation of documents demonstrating that a medical device meets the Essential Principles of Safety and Performance. For Class B, C, and D devices, a technical file must be prepared and submitted (or referenced) as part of the MDA registration dossier.

The depth and comprehensiveness of the technical file increases with device class.

Technical File Structure​

1. Device Description and Specifications​

ElementDetail
Device nameProprietary and generic names
Intended purposeComplete intended use statement
Indications for useClinical indications
ContraindicationsConditions where device must not be used
Target populationPatient age, physiological condition, etc.
Device descriptionPhysical description, dimensions, materials, components
Variants and accessoriesAll variants covered and their differences
Technical specificationsKey performance specifications
Component materialsMaterials in contact with the patient or user

2. Design and Development (Class C and D)​

  • Design history file summary
  • Design input and output documentation
  • Design verification and validation summary
  • Design reviews
  • Design transfer to manufacturing

3. Manufacturing Information​

  • Manufacturing site(s) and roles
  • Key manufacturing processes
  • Process validation summaries (critical processes)
  • Sterilisation method and validation summary (sterile devices)

4. Essential Principles Checklist​

A table cross-referencing each applicable Essential Principle to:

  • The standard(s) used to demonstrate compliance, OR
  • Other means of demonstrating compliance (test reports, clinical data, etc.)

5. Standards Compliance​

For each standard listed in the Essential Principles checklist:

  • Standard title and number
  • Edition/year applied
  • Whether fully or partially complied with
  • If partial: which clauses are not applicable and why

6. Risk Management​

Based on ISO 14971:2019 — Application of risk management to medical devices:

ClassRequirement
Class BRisk management summary (plan, identified hazards, risk evaluation, control measures, residual risk assessment)
Class CFull risk management file
Class DFull risk management file + risk management report

7. Biocompatibility (where applicable)​

Based on ISO 10993 series — Biological evaluation of medical devices:

  • Biocompatibility evaluation plan
  • Material characterisation
  • Test reports for applicable endpoints (cytotoxicity, sensitisation, genotoxicity, etc.)
  • Justification for any test waivers

8. Electrical Safety and EMC (active devices)​

  • Based on IEC 60601-1 (general safety) and relevant particular standards
  • IEC 60601-1-2 (EMC)
  • Test reports from accredited laboratories

9. Software (if applicable)​

Based on IEC 62304 — Medical device software lifecycle processes:

  • Software safety classification (Class A, B, or C)
  • Software development lifecycle documentation summary
  • Verification and validation summary
  • Cybersecurity assessment (see SaMD & Digital Health)

10. Sterility (sterile devices)​

  • Sterilisation method and rationale
  • Sterilisation validation summary (ISO 11135, 11137, 17665 as applicable)
  • Sterile barrier system validation (ISO 11607)
  • Shelf-life validation summary

11. Clinical Evaluation​

ClassClinical Evaluation Requirement
Class AMinimal (literature search sufficient)
Class BClinical evaluation report summarising literature review
Class CFull CER per GHTF SG5 / IMDRF MDCE WG
Class DFull CER with clinical investigation data

12. Labelling​

  • Proposed device label (all versions/configurations)
  • Instructions for Use (IFU)
  • Compliance with Malaysian labelling requirements

Keeping the Technical File Current​

The technical file must be kept current throughout the device's lifetime. Updates required when:

  • Design or manufacturing changes occur
  • New clinical or safety data emerges
  • Post-market surveillance triggers a review
  • Registration renewal is due
Document Control

Maintain strict document version control on all technical file documents. MDA reviewers may query document dates and versions. Undated or un-versioned documents are a common deficiency.