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Medtech Regulatory
Resource Center

Featured Content

May 14, 2024 | By MedTech Intelligence Staff

FDA Issues Final Guidance on Remanufacturing of Medical Devices

The guidance defines remanufacturing, includes relevant considerations to determine if activities are remanufacturing, and provides recommended labeling information to ensure serviced devices are returned to their established performance and safety specification.

May 1, 2024 | By MedTech Intelligence Staff

FDA Releases Laboratory Developed Tests Final Rule

“The final rule announced today aims to provide crucial oversight of these tests to help ensure that important healthcare decisions are made based on test results that patients and health care providers can trust.”

April 10, 2024 | By MedTech Intelligence Staff

Federal Court Enters Consent Decree Against Philips Respironics Following Recall of CPAP Machines

The consent decree restricts the production and sale of new continuous positive airway pressure (CPAP) machines, bi-level positive airway pressure (BiPAP) machines and other devices at several Philips Respironics facilities in the U.S. until certain requirements are met.

April 3, 2024 | By MedTech Intelligence Staff

FDA to Host Virtual Workshop on ASCA Program Expansion

On April 17, the FDA is hosting a Virtual Public Workshop on approaches to Accreditation Scheme for Conformity Assessment Expansion.

March 25, 2024 | By MedTech Intelligence Staff

FDA Proposes Ban on Electrical Stimulation Devices

“These devices present a number of psychological risks including depression, anxiety, worsening of underlying symptoms, development of post-traumatic stress disorder, and physical risks such as pain, burns, and tissue damage.”

See more News at the Medtech Regulatory Resource Center Archive ››




General regulatory

  • The ultimate guide to the EU MDR general safety and performance requirements
  • The ultimate guide to the medical device single audit program (MDSAP)
  • The impact of MDR transition period extensions
  • Software as a medical device (SAMD) - classification overview
  • What is the FDA estar program
  • Exploring the gap between FDA and MDR risk management requirements
  • Regulatory strategy as a competitive advantage
  • Medical device audits - preparation and responses

Market entrance

  • The beginner's guide to the FDA 510(k)
  • The beginner's guide to the FDA PMA submission process
  • The beginner's guide to the FDA De Novo classification process
  • CE marking guide for medical devices in the EU
  • Regulatory clearance for medical devices
  • Regulatory Ask Us Anything: Medical device submission strategy in China
  • FDA listed, cleared, approved, granted - what do these mean, and what’s the difference?
  • FDA medical device registration process - getting new products to market in the U.S.

Regulatory market profiles

  • Austalia market profile
  • Brazil market profile
  • Canada market profile
  • China market profile
  • EU market profile
  • Saudi Arabia market profile
  • United States market profile

Regulatory information management

  • The RIM buyer's guide for medtech companies
  • Making the case for a RIM system
  • RIM for medical devices – challenges and opportunities for automation
  • RIM 101: what is regulatory information management?
  • Top 6 benefits of a regulatory information management (RIM) system for medical devices
  • To build or to buy: evaluating options for Regulatory Information Management
  • RIM - Master data management for RA teams
  • SaaS 101 for medtech regulatory professionals

UDI

  • Why UDI is a regulatory concern – and not just an operational process
  • Quick reference guide - global medical device UDI requirements and timelines
  • BUDI-DI - Basic UDI explained
  • The ultimate guide to the EU MDR/IVDR unique device identifier (UDI) System
  • The ultimate guide to the China UDI system and database
  • Global strategy for Unique Device Identifier (UDI) data

Upcoming Events

  • Informa MedTech Summit

Featured Articles

February 9, 2026
navigating regulatory strategy

Navigating the Global Regulatory Landscape: A Foundation for Medical Device Commercial Viability

By Partha Anbil

Device Makers are currently at an intersection of accelerated innovation and heightened regulatory scrutiny. Regulatory affairs stands in the center guiding operational resilience and a coherent regulatory strategy required by investors.

February 3, 2026
Mental Health Reimbursement

Demand for Non-Pharmacological Mental Health Needs a Delivery System

By Allan Gobbs

The next phase of digital mental health adoption depends less on innovation and more on how the industry uses real-world evidence, builds reimbursement frameworks, and applies regulatory precedent to accelerate scale.

February 3, 2026
Safety of AI in Medical Devices

AI in Medical Devices: Safety Questions the Industry Can’t Afford to Ignore

By Pujitha Gourabathini

Artificial intelligence is moving quickly into mainstream medical devices, and the industry has become fluent in a familiar set of concerns: bias, transparency, and cybersecurity. These topics matter, but they don’t capture the risks most likely to shape patient safety in the coming decade. The deeper challenges lie in the interactions between algorithms, clinical workflows, data pipelines, and human decision making. Those interactions are where safety is won or lost, and they remain the least examined part of AI adoption.

January 20, 2026
Off-label and contraindicated medical device use

The Risk of Using a Device Off-Label Versus Contraindicated

By Attly Aycock

While off-label use may be permissible, contraindicated use still has a strong regulatory boundary as reinforced by FDA guidance finalized in 2025.

January 20, 2026
Balancing Cyber Risk

The FDA Raised the Bar on MedTech Cybersecurity: Are Companies Ready?

By Justin Kozak

In the current Cyber Threat environment, companies must have strong cyber liability insurance. Policies must specifically account for cyber-physical risks and the substantial costs of post-market remediation, including mandatory software patches and patient notifications. Insurers are well aware of the 524B mandate and are increasingly requiring proof of compliance before issuing coverage or offering favorable rates. How do you assure your cyber risk plan insurable?

January 20, 2026
ChatGPT

How ChatGPT Health is rewriting patient engagement

By Christoph Lippuner

A recent survey of 2,000 UK patients found one in four patients (24%) already use AI for health guidance, and nearly one in three (30%) would be willing to consult AI or social media rather than wait to see a clinician. Despite this growing reliance on digital tools, the same survey revealed a disconnect in patient confidence, with almost 80% reporting that they do not feel fully in control of their healthcare. How might ChatGPT Health accelerate this shift, as well as what needs to happen to ensure AI adoption genuinely empowers patients rather than adding further complexity?

January 15, 2026
Domico Med-Device in Mexico

Contract Manufacturer, Domico Med-Device, opens 23,000 sq ft Facility in Mexico

By Randy Knotts

omico’s new facility expands its global production capacity and enhances its ability to be close to customers without taking on excessive risk.

January 6, 2026
Medical Device R&D Bottleneck

R&D Operations Bottlenecks in Large Life Sciences Organizations: What can MedTech Leaders Do?

By Venkatesan (Venkat) Muthukrishnan

How is software-enablement — connected devices and artificial intelligence — reshaping how products are conceived, developed, and deployed in clinical practice? Fragmented operations in large MedTech organizations are not keeping pace with the complexity of products in their pipelines.

View More Combination Products Articles »

TOPICS

  • Digital Health
  • MedTech Economics
  • Manufacturing Execution
  • Product Design & Development
  • Quality/Regulatory

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