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What is the application form for MDSAP registration for medical devices in the United States?
Category：企業(yè)動(dòng)態(tài) Date：2024-11-21 17:08:35 Author: Source:
While there isn’t a specific "MDSAP application form," manufacturers need to engage directly with an accredited auditing body to initiate the process and provide necessary documentation for the audit.

There is no specific "application form" for MDSAP (Medical Device Single Audit Program) registration in the same way that some regulatory programs have standard forms for submission. Instead, the process for MDSAP registration involves several key steps that manufacturers must follow, which are coordinated through accredited auditing organizations. Here's an outline of the process:

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1. Select an Accredited Auditing Organization

  • Manufacturers must choose an MDSAP-recognized auditing organization to conduct the audit. These organizations are authorized by the participating regulatory authorities (FDA, Health Canada, ANVISA, PMDA, and TGA).
  • A list of accredited auditing organizations is available on the official MDSAP website or through the International Medical Device Regulators Forum (IMDRF).

2. Initiate the Audit Process

  • Contact the selected auditing organization to initiate the process. The manufacturer will typically need to provide certain documentation about their company, including:
    • Company profile (legal name, address, etc.)
    • Details of the medical devices to be audited
    • Current Quality Management System (QMS) documentation
    • ISO 13485 certification (if applicable)
    • Information about the manufacturer’s regulatory obligations for other markets (if applicable)

3. Audit Preparation

  • The auditing organization will provide guidance on how to prepare for the audit, including reviewing the QMS to ensure it meets the requirements of ISO 13485 and the regulations for the countries in the MDSAP program (such as FDA’s 21 CFR Part 820 for the U.S.).
  • No formal application form is required here, but manufacturers should ensure they have all the necessary documentation and records ready for the audit.

4. Audit Execution

  • During the audit, the auditing organization will assess the manufacturer’s QMS and compliance with regulatory standards. The audit may include on-site inspections, interviews, and document reviews.

5. Audit Report and Follow-Up

  • After the audit, the auditing organization will issue an audit report outlining the findings, including any nonconformities. If corrective actions are needed, the manufacturer must address them and submit a plan to the auditing organization.

6. Certification Issuance

  • Once the audit is complete and any nonconformities are addressed, the manufacturer will receive the MDSAP certificate, which confirms that the company is compliant with the regulatory requirements of all participating countries, including the FDA in the United States.

Key Documents/Steps to Prepare for MDSAP Registration:

  • Company Profile: Information about the manufacturer and the scope of their operations.
  • QMS Documentation: The quality management system must comply with ISO 13485 and the regulatory requirements of the participating countries.
  • Previous Certifications: Copies of existing certifications such as ISO 13485 (if applicable).
  • Audit Plan: A plan agreed upon with the auditing organization outlining the scope, schedule, and audit activities.

While there isn’t a specific "MDSAP application form," manufacturers need to engage directly with an accredited auditing body to initiate the process and provide necessary documentation for the audit.

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