In the United States, an audit system is not directly required for medical device registration per se, but there are several regulatory processes that can involve audits or inspections. Here’s a breakdown of the relevant requirements:

1. FDA Inspections and Audits:

• The FDA (Food and Drug Administration) can conduct inspections of medical device manufacturers to ensure compliance with the Quality System Regulation (QSR) under 21 CFR Part 820. This is an audit of the manufacturer’s quality management system (QMS), and it is typically done after a device is already on the market or during periodic inspections.
• However, the FDA does not require manufacturers to undergo an audit before registration or market approval. The FDA can inspect a facility at any time to ensure compliance with the QSR and other regulations.

2. MDSAP (Medical Device Single Audit Program):

• While not required by the FDA itself, the MDSAP program, which allows for a single audit to satisfy the regulatory requirements of multiple countries (including the U.S.), can be an alternative for certain manufacturers. An MDSAP audit evaluates compliance with the quality system requirements of the FDA, as well as other participating countries (Canada, Japan, Brazil, Australia).
• For manufacturers who choose to participate in MDSAP, an external, third-party auditor assesses their compliance with the FDA's QSR.

3. Registration Requirements:

• The primary requirement for FDA registration involves submitting a Device Listing and ensuring that the medical device complies with FDA regulations, such as obtaining a 510(k) clearance or Premarket Approval (PMA), depending on the device classification.
• While audits are not a mandatory part of the registration process itself, compliance with the FDA QSR (which can be audited) is necessary for continued market access.

4. ISO Certification (Optional but Recommended):

• Many manufacturers also seek ISO 13485 certification for their quality management system (QMS). This is not a requirement by the FDA, but ISO 13485 certification can be a way to demonstrate compliance with quality system requirements, and it may facilitate smoother FDA inspections or approvals.
• ISO audits are conducted by third-party organizations and are separate from FDA audits, but having ISO 13485 certification can streamline the process when FDA inspections occur.

In Summary:

• No, an audit system is not specifically required for the FDA registration of medical devices in the United States.
• However, manufacturers must comply with Quality System Regulations (QSR), and the FDA can inspect facilities to verify compliance.
• Third-party audits such as those under the MDSAP program or ISO 13485 certification can be helpful but are not mandatory for FDA registration.

The registration process mainly involves documentation, device classification, and regulatory submissions, but the FDA can conduct audits or inspections as part of its enforcement activities.

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