For Class D medical device registration with the Medical Device Authority (MDA) in Malaysia, specific technical documentation is required to demonstrate the safety, efficacy, and quality of the device. Here are the key technical document requirements:

1. Device Description:

• A comprehensive description of the device, including its intended use, indications, and any relevant specifications or standards.

2. Risk Management File:

• Documentation in accordance with ISO 14971 that includes:
  • Identification of potential hazards.
  • Risk assessment and analysis.
  • Mitigation strategies and risk control measures.
  • A summary of the risk management process.

3. Clinical Evaluation Report:

• A detailed report providing evidence of the device's safety and efficacy. This may include:
  • Results from clinical studies or trials.
  • Literature reviews that support the clinical claims.
  • Post-market surveillance data, if applicable.

4. Quality Management System Documentation:

• Proof of compliance with ISO 13485, including:
  • Quality policy and objectives.
  • Procedures for manufacturing, quality control, and product testing.
  • Documentation of audits and corrective actions.

5. Labeling and Packaging Information:

• Samples or detailed descriptions of the labeling, including:
  • Instructions for use.
  • Safety warnings and contraindications.
  • Symbols and information required by regulations.

6. Manufacturing Information:

• Details about the manufacturing processes, including:
  • Descriptions of production facilities and equipment.
  • Quality assurance practices and controls.
  • Compliance with Good Manufacturing Practices (GMP).

7. Declaration of Conformity:

• A formal declaration stating that the device complies with applicable regulatory requirements and standards.

8. Supplementary Information (if applicable):

• Any additional documents that may support your application, such as:
  • Previous regulatory approvals (e.g., from other countries).
  • Certificates of compliance or quality assurance.

9. Post-Market Surveillance Plan (if applicable):

• Outline a plan for monitoring the device's performance and safety after it is on the market, including how to report and manage adverse events.

Summary:

When preparing your technical documentation for Class D medical device registration, ensure that each document is thorough, well-organized, and compliant with MDA requirements. This comprehensive approach will facilitate the evaluation process and enhance the chances of a successful registration.

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