Medical Device Regulations & Compliance

INDUSTRY PERSPECTIVES

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    India Aims To Boost Medical Device Industry With New Initiative

    India's government has approved a new initiative aiming for a 20% annual growth rate for medical devices, which is dubbed as a "Sunrise Sector." The initiative will streamline regulations, add a new push for manufacturing capacity, and strengthen opportunities for R&D collaboration. The aim is for both local and global companies to benefit.

EU Medtech Labeling Compliance & The Competitive Advantage Of A Digitalized Process

In the medtech industry where time and regulatory compliance are crucial, optimizing and digitalizing your labeling processes are essential for bringing medical devices to market quickly and play a vital role in keeping products available to patients and healthcare providers in the EU.

Risk Tool Selection With ICH Q9(R1) In Mind

This article focuses on the formality concept discussed in the revision of ICH Q9 Quality Risk Management released earlier in 2023. The authors provide a helpful overview of what risk tools are appropriate to use during certain types of scenarios, and what the team composition should look like.

FDA’s Grace Period For Medical Device Cybersecurity Is Over. Are You Ready?

The FDA had established a grace period for all medical device manufacturers to ensure that you are incorporating cybersecurity during the design and validation of cyber devices. The end date of the grace period, and the seminal date in medical device cybersecurity enforcement, is Oct. 1, 2023. Are you prepared?

A Brief Guide To ISO 13485’s Design Controls In Medical Device Development

Design controls play a crucial role in the medical device development process by providing a systematic approach to manage risks, design requirements, and verification and validation activities. Let's explore the key elements of ISO 13485 that will help you manage the process effectively.

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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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