Certification Introduction

For medical devices to enter the U.S. market, they must be regulated by the U.S. Food and Drug Administration (FDA). A classified access management system is implemented based on product risk levels, and obtaining FDA compliance access is a necessary prerequisite for products to be legally sold in the U.S. market. Enterprises need to match the corresponding compliance path according to product classification to ensure that they meet the safety and performance requirements specified by FDA.

Laws and Regulations

U.S. medical device regulation takes Title 21 of the Code of Federal Regulations (21 CFR) as the core basis, implements 21 CFR Part 820 Quality Management System Regulation (abbreviated as QMSR), as well as special procedural rules corresponding to 510(k) pre-market notification and PMA pre-market approval. All medical devices must complete FDA product registration and product listing, and most low-risk Class I devices can be exempted from pre-market review requirements.

Technical Requirements

FDA classifies medical devices into Class I (low risk), Class II (medium risk) and Class III (high risk) based on risk levels, and different categories correspond to differentiated access and control requirements. Manufacturers shall establish and operate a quality management system that meets the requirements of 21 CFR Part 820 Quality Management System Regulation (QMSR), while complying with relevant standards of ISO 13485 and ISO 14971. Complete technical documentation shall be provided, including product description, performance test report, biocompatibility evaluation, sterility verification (if applicable) and other contents. High-risk products need to supplement clinical trial data and other relevant materials. All non-clinical test reports supporting marketing applications shall comply with FDA GLP (Good Laboratory Practice) requirements to ensure the data is authentic, compliant and traceable. Products shall comply with FDA regulatory requirements for labeling and identification, and establish a post-market adverse event monitoring and feedback mechanism.

Certification Process

Confirm product risk classification and clarify the applicable access path and compliance requirements.

Appoint a qualified U.S. Agent as the legal contact body between FDA and non-U.S. manufacturers.

Register FDA payment accounts, complete the filing of enterprise subject information, and obtain compliance operation permissions.

Prepare technical documents that meet requirements, establish and operate a quality management system conforming to QMSR standards.

Submit corresponding access applications according to product classification: Exempt Class I products can directly go through the product listing process; most Class II products submit 510(k) pre-market notification to prove substantial equivalence to the legally marketed predicate device; Class III high-risk products submit PMA pre-market approval application and provide complete clinical evidence.

Pay the corresponding application fee as required by FDA (such as 510(k)/PMA review fee) and complete payment confirmation.

Cooperate with FDA's technical review and supplement materials as required.

After passing the review and obtaining access approval, pay the annual enterprise registration fee, complete facility registration and product listing, and obtain market circulation qualification.

After the product is legally launched in the U.S. market, enterprises need to continuously fulfill regulatory obligations such as post-market adverse event reporting and annual review, accept possible unannounced inspections by FDA, cooperate with on-site inspections and implement rectifications.

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