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Technical Dossier Requirements

The technical dossier (expediente técnico) is the package of documentation submitted to COFEPRIS to support a sanitary registration application under the standard route. Requirements scale with device class.

Core dossier elements​

1. Device description & intended use​

  • Generic name and trade name of the device.
  • Clear description of the device, its components, materials, and accessories.
  • Intended use statement — the clinical purpose, patient population, and conditions of use.
  • Contraindications (if applicable).

2. Technical specifications​

  • Design drawings or schematics (as applicable).
  • Material specifications.
  • Dimensional specifications.
  • Sterilisation method and validation data (for sterile devices).
  • Shelf life and storage conditions.

3. Biocompatibility​

For devices that contact the patient, biocompatibility data in accordance with ISO 10993 is required:

  • List of materials in contact with the patient.
  • Biocompatibility testing results or justification for test exemption.

4. Clinical evidence​

ClassClinical evidence expectation
Class ILiterature review; may use published data on substantially similar devices
Class IILiterature review + clinical evaluation report; clinical study data for novel or higher-risk Class II
Class IIIComprehensive clinical evidence including clinical study data, performance evaluation, benefit–risk analysis

5. Risk management​

A risk management summary or report prepared in accordance with ISO 14971, covering:

  • Identified hazards and hazardous situations.
  • Risk control measures.
  • Residual risk assessment.

6. GMP documentation​

Evidence of quality system compliance — one of the following:

  • ISO 13485 certificate (most widely accepted).
  • MDSAP audit report.
  • Certificate of Good Manufacturing Practices issued by a recognised authority.
  • Evidence of NOM-241-SSA1-2025 compliance.

7. Labelling​

  • Draft Spanish-language label compliant with NOM-137-SSA1-2008.
  • Instructions for Use (IFU) in Spanish.
  • Sterilisation and storage symbols (compliant with ISO 15223).

8. Administrative documents​

  • Power of attorney appointing the MRH (for foreign manufacturers).
  • Proof of fee payment (pago de derechos).
  • MRH's operating notice (Aviso de funcionamiento).

IVD-specific additions​

For IVD devices, include:

  • Analytical performance data (sensitivity, specificity, precision, linearity).
  • Clinical performance validation data.
  • Reference intervals and calibration information.
  • Stability data for reagents.

Language requirement​

All documents submitted to COFEPRIS must be in Spanish or accompanied by an officially certified Spanish translation.

Expand section '4. Clinical evidence' to include: "Class II devices may be divided into two subcategories: (a) substantially similar to existing marketed devices may require only a clinical evaluation report and published literature review; (b) novel Class II or higher-risk Class II devices typically require clinical study data, which may be from published literature, registry data, or sponsored studies. COFEPRIS recommends pre-submission consultation for novel Class II devices to clarify evidence expectations."