Applying for US FDA registration does not inherently require ISO 13485 certification, but having ISO 13485 certification can greatly facilitate the process. ISO 13485 is an international standard that specifies requirements for a quality management system specifically tailored for medical devices. While compliance with ISO 13485 is not mandatory for FDA registration, it demonstrates conformity to internationally recognized quality management practices, which aligns closely with FDA expectations for ensuring the safety and effectiveness of medical devices.

For manufacturers seeking FDA registration, having ISO 13485 certification can streamline the process by providing a structured framework for managing regulatory compliance, quality control, and risk management throughout the device lifecycle. It can also enhance credibility and market acceptance by demonstrating commitment to quality and regulatory compliance standards beyond FDA requirements.

However, FDA regulations primarily focus on ensuring that medical devices marketed in the United States meet specific safety and effectiveness criteria outlined in the Federal Food, Drug, and Cosmetic Act (FD&C Act). Compliance with FDA's Quality System Regulation (QSR), also known as 21 CFR Part 820, is mandatory for FDA registration and approval. This regulation outlines requirements for the design, production, distribution, and post-market surveillance of medical devices sold in the United States.

In summary, while ISO 13485 certification is not a strict requirement for FDA registration, it can significantly support the regulatory compliance efforts of medical device manufacturers. It demonstrates adherence to rigorous quality management principles that are highly valued in global markets, including the United States, enhancing the likelihood of successful FDA registration and commercial success in the medical device industry.

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