Medical Device Regulations & Compliance

INDUSTRY PERSPECTIVES

China In The Global Medtech Industry: Equal Parts Promising And Uncertain

While China is the world’s second biggest market, its activities are mostly focused on its own internal market and a few others. Some new developments are promising, and others raise questions.

How The Right Operating Model For EU MDR Compliance Can Support A Global Footprint

EU MDR has raised the bar compared to other jurisdictions in areas such as stronger emphasis on collecting pre- and post-market data. If you align your operating model for EU compliance, you'll be in a better position to enter other markets.

Integrating Quality Processes And Documentation After A Merger

If your company is undergoing a merger, you must juggle operations while ensuring minimal disruptions. You'll need a holistic view of QMS and SOPs to harmonize procedures.

Long Live Design Controls: Navigating The Shift From QSR To QMSR

The transition to a Quality Management System Regulation (QMSR) has effectively superseded the explicit medical device design controls CFRs and associated FDA guidance, though their essence lives on.

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WHITE PAPERS & CASE STUDIES

Eccentric Loading Test (Eccentricity) With External Test Weights

In many laboratories, weighing is a critical process. This operating procedure describes how to perform an eccentric loading test with external test weights.

One-Point Calibration With External Test Weights

This operating procedure describes how to perform a one-point calibration with external test weights, which is one of the recommended tests to ensure laboratory balances are working correctly.

Performance Test According To Chapter 2.1.7 Of The Ph. Eur.

This operating procedure describes how to perform a repeatability and sensitivity test according to Chapter 2.1.7. of the European Pharmacopoeia.

Repeatability Test With External Test Weights

A repeatability test with external test weights is one of the recommended tests to ensure balances are working correctly. This operating procedure describes how to perform a repeatability test with external test weights.

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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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