The core requirements for medical device registration under the MDSAP (Medical Device Single Audit Program) system in the United States are primarily focused on ensuring that manufacturers comply with quality management system (QMS) standards. The MDSAP system allows for a single audit to satisfy the regulatory requirements of multiple participating countries, including the U.S. (FDA), Canada, Brazil, Japan, and Australia. Below are the core requirements for registration under the MDSAP system in the U.S.:

1. Compliance with ISO 13485:2016

• The manufacturer must implement a Quality Management System (QMS) that meets the requirements of ISO 13485:2016. This international standard outlines the criteria for a QMS that ensures devices are consistently produced and controlled according to quality standards.
• The system must cover all aspects of design, development, manufacturing, and post-market surveillance.

2. Compliance with FDA's Quality System Regulations (QSR)

• In addition to ISO 13485, the manufacturer must ensure their QMS complies with the FDA's Quality System Regulations (QSR), specifically 21 CFR Part 820. This regulation outlines the requirements for medical device manufacturers in the U.S., covering areas like production, labeling, design controls, and recordkeeping.

3. MDSAP Audit

• The manufacturer must undergo an MDSAP audit conducted by an authorized MDSAP-recognized auditing organization. This audit will review compliance with both ISO 13485 and FDA's QSR, as well as other applicable regulations for the participating countries.
• The audit covers several areas, including:
  • Management responsibility
  • Resource management
  • Design and development
  • Production and process controls
  • Post-market surveillance
  • Corrective and preventive actions (CAPA)

4. Post-Market Surveillance and Reporting

• Manufacturers must demonstrate their ability to monitor and manage their medical devices once they are on the market. This includes establishing a system for adverse event reporting, device recalls, and ongoing safety monitoring.
• Compliance with the FDA's Medical Device Reporting (MDR) requirements is a critical part of this.

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

• The manufacturer must maintain detailed records that document the specifications, design, production processes, and testing of the medical device.
• The Device Master Record (DMR) outlines all the specifications for the device, while the Device History Record (DHR) ensures that the device was made according to these specifications.

6. FDA Registration and Listing

• As part of the MDSAP process, the device must be FDA registered and listed with the FDA. This involves submitting a Form 3514 for registration and listing the device with the FDA's Device Registration and Listing System (DRLS).
• Manufacturers must provide information about the device, its intended use, and any relevant details for regulatory compliance.

7. Labeling and Instructions for Use

• Manufacturers must ensure that the device labeling, including instructions for use, complies with FDA regulations under 21 CFR Part 801. This includes labeling that provides adequate instructions, warnings, and precautions for users.

8. Clinical Evidence (if required)

• For certain higher-risk devices, clinical evidence demonstrating the device’s safety and efficacy may be required, especially for devices that are not significantly equivalent to a predicate device under the FDA’s 510(k) process.
• The manufacturer must be able to submit clinical trial data or other forms of evidence to support claims about the device’s safety and performance.

9. Corrective and Preventive Actions (CAPA) System

• The manufacturer must have an effective CAPA system to identify, investigate, and correct any problems or deficiencies in the device or its processes.
• This is a key part of the FDA's and ISO 13485's expectations for continuous quality improvement.

10. Device Class and Regulatory Pathway

• The device's classification under the FDA's medical device classification system (Class I, II, or III) will determine the specific regulatory pathway for approval. For example:
  • Class I devices generally require registration but may not need premarket approval.
  • Class II devices often require 510(k) clearance before they can be marketed.
  • Class III devices require Premarket Approval (PMA), which is a more rigorous process.

Summary

To sum up, the core requirements for medical device registration under the MDSAP system in the U.S. include compliance with ISO 13485, FDA's Quality System Regulations, successful completion of an MDSAP audit, device registration and listing, post-market surveillance, and adherence to other FDA-specific requirements such as labeling and reporting. The goal of MDSAP is to streamline the process for manufacturers by reducing the need for multiple audits across different countries, while ensuring that devices meet the necessary safety and quality standards.

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