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Resource Library for Medical Device Professionals

Resource Library for Medical Device Professionals

325 total results. Use the filters to narrow down the results.
South Korea

MFDS - South Korea Ministry of Food and Drug Safety

Learn about the regulatory structure in South Korea and major medical device regulations.

Compare the time, cost and complexity of getting regulatory approval for medical devices
South Korea

Time, Cost and Complexity of Regulatory Approvals Worldwide

Use this interactive table to estimate how long it takes to gain approval in popular markets worldwide, along with associated costs.

Taiwan

Taiwan TFDA Medical Device Registration Requirements

This white paper discusses how to register your medical device with the TFDA in Taiwan.

Taiwan

Introduction to Taiwan's Medical Device Approval Process

This video about Taiwan's medical device market gives an overview of the regulatory framework and registration process basics.

Download the free chart: Taiwan Regulatory Approval Process for Medical Devices
Taiwan

Taiwan TFDA Regulatory Approval Process for Medical Devices

This chart illustrates the steps in Taiwan's TFDA medical device approval process and includes a timeline of expected approval.

Taiwan

Medical Device Consulting Services for Taiwan

Interested in selling your medical device or IVD in Taiwan? Emergo offers a wide range of regulatory, representation, QA and other services for companies looking to enter this market.

Taiwan

In Depth: Taiwan Medical Device Approval and Compliance

This video about the Taiwan medical device market shows you the process and identifies the key concepts to know before you begin.

Learn about the Taiwanese Department of Health regulations which apply to medical devices
Taiwan

Taiwan Medical Device Regulations

A comprehensive list of medical device regulations in Taiwan with links to the original documents.

Taiwan

TFDA - Taiwan Food and Drug Administration

Learn about the regulatory structure in Taiwan and major medical device regulations.

Compare the time, cost and complexity of getting regulatory approval for medical devices
Taiwan

Time, Cost and Complexity of Regulatory Approvals Worldwide

Use this interactive table to estimate how long it takes to gain approval in popular markets worldwide, along with associated costs.

United States | Digital Health Products, | Health and Wellness Products

Wearables vs. Regulated Medical Devices under the US FDA

In this white paper, we discuss how to determine if your wearable product is considered a regulated medical device by the US FDA.

Our 510(k) calculator looks how long it has taken the FDA to clear specific devices during the past five years.
United States

How Long Will It Take My 510(k) to be Cleared by the FDA?

Use this calculator to see how many calendar days it usually takes the US FDA to clear medical devices with the same Product Code.

Register for our webinar: Mapping UL 2900 Cybersecurity Standards to FDA Guidance
United States | Digital Health Products

WATCH NOW: Mapping cybersecurity standards to FDA guidance

A set of standards published by UL to address medical device cybersecurity issues will soon be adopted. In this one hour webinar, we discuss various aspects of medical device cybersecurity and how the new UL 2900 standards map to FDA guidance.

Learn about the US FDA regulations which apply to medical devices
United States

USA Medical Device Regulations

A comprehensive list of medical device regulations in United States with links to the original documents.

United States

Introduction to US FDA Medical Device Regulatory Process

This video about the United States medical device market gives an overview of the regulatory framework and registration process basics.

United States

Understanding the US FDA Device Classification System

Correct classification of a medical device is critical for identifying its proper regulatory route in the United States.

United States

In Depth: The US FDA 510(k) Clearance Process

In this 8-minute video, we discuss the steps you should take to prepare and submit a 510(k) to the US FDA.

United States

Introduction to the UDI System in the USA

This video describes key aspects of the FDA UDI system, why it is necessary, benefits, and when and how device manufacturers need to comply.

United States

Understanding the US FDA UDI Regulation

Learn about the Unique Device Identification (UDI) regulation, how to obtain a UDI number, compliance deadlines, and more.

United States

In Depth: US FDA Medical Device Registration and Compliance

This video series about the United States' medical device market shows you the process and identifies the key concepts to know before you begin.

Download the Chart on the Medical Device Approval Process in the USA
United States

US FDA Registration Process for Medical Devices

This chart illustrates the steps in the US FDA's medical device approval process and includes a timeline of expected approval.

United States

Preparing a US FDA Medical Device 510(k) Submission

US FDA 510(k)s have unique content and format requirements. Get an overview of preparing and submitting a 510(k).

United States

What to Expect During an FDA QSR Inspection

This paper describes exactly what to expect from a random FDA audit and how to prepare for the inspector's arrival in a concise checklist.

United States

Regulations for Companion Diagnostics in the US and EU

In this paper, we answer your biggest questions about the obstacles and opportunities of marketing companion diagnostics in the US and Europe.

United States

In Depth: 21 CFR Part 820 - FDA Quality System Regulation

In this video, we’ll take a look at 21 CFR Part 820, including an overview, key players, important sections, and how to maintain compliance.

Fill out our short form to request information about the USA
United States

Get smart about the USA in 1 hour

Thinking about entering the US market for the first time? Understanding the FDA regulatory requirements can be overwhelming and confusing. We assembled a packet that includes the basic information you need before deciding to enter the US market.

United States | Digital Health Products

US FDA Cybersecurity Requirements for Medical Devices

In this white paper, we discuss US regulations for wireless medical devices, including submission requirements, risk management, and more.

United States

Implementing a Medical Device Post-Market Surveillance Program

Post-market surveillance is a regulatory requirement the US and Europe and helps you ensure your device's safety and effectiveness.

United States

Early Communication with the FDA

Discover guidelines, tips, and other useful information about corresponding with the FDA about the clearance of your medical device.

United States

Determining Substantial Equivalence for FDA Device Clearance

Learn about substantial equivalence, which is the key to getting your Class II medical device cleared for sale by the US FDA.

United States

US FDA Regulation of Human Cell and Tissue Products

Does your medical device contain animal or human cells or tissues? Learn about FDA requirements for these products.

United States

Overview of the USA FDA Classification Process

This short video covers FDA classification, how to use the classification database, and useful tips for classifying your medical device.