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Glossary Term
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Market Authorization Holder (MAH)

Definition

A Market Authorization Holder (MAH) is the entity legally responsible for a medical device, drug, or therapy once it has received regulatory approval for sale in a specific region. The MAH oversees compliance with regulatory requirements, including post-market surveillance, adverse event reporting, labeling updates, and quality assurance throughout the product lifecycle.

Relevance to the MedTech Industry

The MAH ensures that the approved medical device complies with applicable laws and regulations in the region where it is marketed. This role is critical for maintaining product safety, quality, and efficacy while addressing regulatory obligations such as reporting, recalls, and inspections.

Additional Information & Related Terms

Responsibilities of a Market Authorization Holder

  1. Regulatory Compliance

    • Ensure adherence to regional regulatory frameworks, such as FDA regulations, EU MDR, or Japan’s PMDA requirements.

    • Maintain up-to-date technical documentation, including device labeling and instructions for use.

  2. Post-Market Surveillance

    • Monitor product performance in real-world settings through clinical data collection and feedback.

    • Report adverse events and field safety corrective actions (FSCAs) to relevant authorities.

  3. Quality Assurance

    • Oversee manufacturing and supply chain quality to ensure consistency and compliance.

    • Ensure that any changes to the device or its manufacturing process are validated and approved.

  4. Inspections and Audits

    • Cooperate with regulatory authorities during inspections, audits, or reviews.

  5. Labeling and Updates

    • Manage updates to product labeling, packaging, and promotional materials to reflect regulatory changes or new safety information.

  6. Product Recalls or Withdrawals

    • Coordinate recalls or market withdrawals if safety or compliance issues arise.


Related Terms

  • Regulatory Approval: The process leading to the authorization for a product to be marketed.

  • Post-Market Surveillance (PMS): Ongoing monitoring of product performance and safety after approval.

  • Good Manufacturing Practices (GMP): Standards ensuring the consistent quality of products throughout production.

  • Adverse Event Reporting: Submitting reports to regulatory authorities about device-related safety issues.

  • Notified Body: Independent organization that evaluates compliance for CE-marked devices in the EU.

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