Medical Device Regulations & Compliance

INDUSTRY PERSPECTIVES

Why Your LATAM Authorized Representative Strategy Is A Market Entry Decision, Not A Clerical One

Across Latin American medical device markets, the local authorized representative that holds or manages the regulatory asset becomes the operational choke point for importation, renewals, and more.

Use Of AI In FDA Inspection Activities: Strategies For Effective Preparation

Are you ready? FDA has begun to implement the use of artificial intelligence in its operations, particularly during inspection activities.

What Is Computer Software Assurance, And What Are Its Benefits?

Kamila Novak reviews final computer software assurance (CSA) guidance and what it means for those working on medical device clinical trials.

Risk Is the Spine: What The First 100 QMSR Inspections Reveal

The FDA has now completed just over 100 inspections under its new Quality Management System Regulation, and the agency has begun sharing preliminary observations from those inspections.

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WHITE PAPERS & CASE STUDIES

ISO 18562 Series 2024: Essential Updates And Testing Requirements

Taking a proactive approach to compliance can help minimize regulatory risks, avoid submission delays, and ensure continued market access.

The Role Of Processing And Supplier Diversification

Optimizing UHMWPE implants requires balancing materials, processing, and sourcing to improve performance, reduce risk, and lower costs in medical device manufacturing.

Accuracy, Safety And Ease Of Use

Safety, ease of use, and accuracy guide modern medical device design, advancing through improved materials, engineering innovation, standards adoption, and user‑centered development.

Effective Strategies To Minimize Product Loss During Fill Finish

Every drop of high-value biologic lost in fill finish is money left on the table. Learn practical strategies to protect your yield.

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ABOUT MEDICAL DEVICE REGULATIONS & COMPLIANCE

Medical devices, from ideation to post-launch assessment, are regulated in the United States by the U.S. Food and Drug Administration (FDA) under the Medical Device Regulation Act of 1976 and subsequent amendments to the Federal Food, Drug and Cosmetics Act of 1938.

The FDA’s medical device regulatory pathways — for premarket review, clearance, and approval — are based on three classifications, indicating the degree of regulatory control necessary to ensure a device’s safety and effectiveness. Class I devices are considered low-risk, and many are exempt from the regulatory process. Class II devices require special controls for “labeling, guidance, tracking, design, performance standards, and postmarket monitoring,” and most require premarket notification 510(k) to demonstrate substantial equivalence (having the same intended use and technological characteristics) to a legally marketed device. Class III devices usually sustain or support life, are implanted, or present a significant risk of illness or injury. Most class III devices require premarket approval (PMA), which examines a variety of factors in weighing the probable health benefits from intended use of a device versus the probable risks.

Medical device makers must adhere to Current Good Manufacturing Practice (CGMP) regulations, which FDA inspectors use to determine if a manufacturer has the facilities, skills, and equipment to produce and pack its product. In addition, the FDA requires all medical devices to carry a unique device identifier (UDI), readable by both machines and humans, to “improve patient safety, modernize device postmarket surveillance, and facilitate medical device innovation.”

Medical device makers competing in international markets must monitor and adhere to the policies of foreign regulatory bodies, which can vary greatly, depending on the nation. Further, many global regulators require manufacturers to be certified by the International Organization for Standardization (ISO). ISO 13485 compliance, confirmed through third-party (Notified Body) audits, demonstrates a medical device manufacturer’s procedures and products meet or exceed international quality standards.

Efforts are also underway to standardize international regulations to ensure the safety, effectiveness, and quality of medical devices. The International Medical Device Regulators Forum (IMDRF) — composed of regulatory agencies from Australia, Brazil, Canada, China, Europe, Japan, Russia, and the United States — is building upon previous work by the Global Harmonization Task Force on Medical Devices (GHTF) to speed this harmonization and convergence.

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