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What Samples are Required for Medical Device Registration under the MDSAP System in the United States?
Category：企業(yè)動(dòng)態(tài) Date：2024-11-26 17:15:28 Author: Source:
While physical samples may not always be required under the MDSAP process, the manufacturer must ensure all necessary documentation is in place for the audit and subsequent regulatory submission. If you are uncertain about the specific requirements for your device, it is advisable to consult with the FDA or a regulatory expert familiar with MDSAP.

Under the MDSAP (Medical Device Single Audit Program) system, which is recognized by the FDA and several other regulatory authorities, the requirement for providing samples for medical device registration may depend on the specific device and its classification. However, generally speaking, the FDA does not require physical product samples for the initial registration of a medical device in the MDSAP program. Instead, the focus is on the quality management system (QMS) audit and ensuring that the manufacturer complies with regulatory requirements.

Here's what is typically involved:

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1. Quality Management System (QMS) Documentation

  • The MDSAP audit assesses whether the manufacturer complies with the QMS standards, which include ISO 13485 and FDA's Quality System Regulations (QSR).
  • Documentation of the design, development, manufacturing, and post-market activities is crucial for the audit.

2. Device Master Record (DMR) and Device History Record (DHR)

  • These records should be available for review during the audit. They provide a detailed history of the product, including design, production, and testing.

3. Product Testing and Risk Management Documentation

  • Testing data, clinical trials (if applicable), and risk analysis documentation may be required to demonstrate that the device meets safety and effectiveness standards.

4. Device Labeling and Instructions for Use

  • These should comply with FDA regulations and be ready for review during the audit.

5. Post-Market Surveillance Documentation

  • Information related to adverse events, recalls, and ongoing monitoring of device performance after market introduction may be necessary for MDSAP compliance.

6. Physical Product Samples (if applicable)

  • In some cases, the FDA or other regulatory authorities might request samples of the medical device during the registration process to ensure the device meets safety and performance standards.
  • However, this is not always required for the MDSAP audit itself unless specific concerns arise during the review of documentation.

7. Clinical Evidence

  • For higher-risk devices, clinical evidence may be requested to demonstrate the device's safety and efficacy.

While physical samples may not always be required under the MDSAP process, the manufacturer must ensure all necessary documentation is in place for the audit and subsequent regulatory submission. If you are uncertain about the specific requirements for your device, it is advisable to consult with the FDA or a regulatory expert familiar with MDSAP.

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