A submission-ready technical file is not the folder with the largest number of reports. It is a connected evidence system explaining what the device is, what it claims, what can go wrong, and how risk controls, testing, and clinical evidence support safety and performance. Before MDMA submission, test those connections rather than checking file names alone.

1. Device identity and dossier scope

  • Legal manufacturer, sites, and roles are consistent.
  • Models, versions, accessories, and configurations are defined without conflicts.
  • Intended purpose, users, patient or specimen, and use environment are clear.
  • Labeling, instructions, and promotional material do not exceed supported claims.
  • The rationale for grouping devices in one application is documented.

2. Classification and Essential Principles

Connect device characteristics and intended purpose to each applicable classification rule. Use the Essential Principles checklist as a traceability tool: each applicable principle should point to a conformity method, evidence, and dossier location.

3. Risk management is not an isolated document

Test whether identified risks connect to design requirements, controls, verification results, labeling, clinical evaluation, and post-market information. A hazard with no visible effect on testing or warnings indicates broken traceability.

4. Verification, validation, and testing

DomainReadiness question
PerformanceAre specifications, acceptance criteria, and results available for each material claim?
SafetyAre applicable electrical, mechanical, thermal, and other tests current?
BiocompatibilityIs the evaluation based on contact, materials, and the final device?
Sterilization and packagingAre sterilization, barrier integrity, shelf life, and transport supported?
Software and cybersecurityAre lifecycle, risks, verification, releases, and vulnerabilities controlled?

5. Clinical evidence or IVD performance evidence

Evidence must answer the claims, target population, intended use, and residual risks. A general bibliography is not enough. Review the search strategy, data quality, applicability, equivalence where used, unresolved gaps, and post-market plan. For an IVD, distinguish scientific validity, analytical performance, and clinical performance.

6. Labeling and instructions for use

  • Names, models, and intended purpose match the dossier.
  • Warnings and contraindications arise from risk and evidence files.
  • Symbols, language, and UDI duties follow current requirements.
  • Version and translation controls prevent obsolete content.
  • No promotional claim exceeds the technical or clinical evaluation scope.

7. Quality system and post-market planning

Connect technical documentation to QMS processes for document control, design and change, suppliers, complaints, CAPA, vigilance, and post-market surveillance. MDS-G024 maps ISO 13485 to SFDA requirements, but a certificate alone is not sufficient evidence for the safety and performance of a specific device.

8. Build a closable gap register

FieldWhat to record
ObservationThe specific missing item, conflict, or weakness.
ImpactThe affected requirement, claim, or risk.
PriorityCritical, major, or improvement.
ActionThe decision, document, or test required.
Owner and dateWho closes the gap and by when.
Closure criterionEvidence demonstrating resolution.

References: [1] [2] [3]

Official sources

  1. SFDA — Requirements for Medical Devices Marketing Authorization (MDS-REQ 1), Version 6.0
  2. SFDA — Guidance for ISO 13485 Requirements and Corresponding SFDA-MDS Requirements (MDS-G024)
  3. SFDA — Requirements for Licensing of Medical Devices Establishments (MDS-REQ9), Version 2.0, 15 January 2025