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Resource Library for Medical Device Professionals

Resource Library for Medical Device Professionals

329 total results. Use the filters to narrow down the results.
Europe

FRANCE – Overview of medical device industry and healthcare statistics

A brief look at France's medical device market, including potential opportunities and obstacles for manufacturers.

Europe

ASNM - French Agency for the Safety of Health Products

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

Europe

Medical Device Risk Management in the New Regulatory Environment

Regulatory expectations for risk management are increasing - what does this mean for medical device companies?

Europe

What is a Clinical Evaluation Report (CER)?

Learn about Clinical Evaluation Reports (CERs) in this informative page from Emergo

Germany

BfArM - Germany Federal Institute for Drugs and Medical Devices

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

Download the Chart on the Medical Device Approval Process in Hong Kong
Hong Kong

Hong Kong Approval Process for Medical Devices

This chart illustrates the steps in the Hong Kong MDCO medical device approval process and includes a timeline of expected approval.

Hong Kong

Medical Device Consulting Services for Hong Kong

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

Hong Kong

MDCO - Hong Kong Medical Device Control Office

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

Learn about the Hong Kong regulations which apply to medical devices
Hong Kong

Hong Kong Medical Device Regulations

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

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

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.

India | Medical Devices

India Approval Process for Medical Devices

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

India | Medical Devices

WHITE PAPER: The New India Medical Device Rules, 2017

In this in-depth white paper, we review India's new Medical Device Rules, 2017 and what you should know to achieve CDSCO compliance.

India

Medical Device Consulting Services for India

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

Learn about basic demographic and healthcare market data on India
India

INDIA – Overview of medical device industry and healthcare statistics

A brief look at India's medical device market, including potential opportunities and obstacles for manufacturers.

India

CDSCO Overview - India Central Drugs Standard Control Organization

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

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

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.

India | Combination Products

WATCH NOW: Human Factors Engineering for Combination Products

In this one-hour webinar, we discuss HFE requirements for combination products.

Learn about the Indian regulations which apply to medical devices
India

India Medical Device Regulations

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

Israel

Medical Device Consulting Services for Israel

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

Israel

Introduction to the Israel AMAR Medical Device Registration Process

This short video covers how to register your medical device with AMAR in Israel.

Japan

In Depth: Japan Medical Device Approval and Compliance

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

Japan

Japan's New QMS Conformity Assessment System

In this white paper, we discuss quality system assessment under Japan's new regulation, the Pharmaceutical and Medical Device Act.

Japan

Japan's Pharmaceutical and Medical Devices Act (PMD Act)

In this white paper, we discuss how to register a medical device for sale in Japan as a foreign company and requirements to be aware of.

Japan

Introduction to Japan's Medical Device Approval Process

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

Download Regulatory Process for Medical Devices in Japan
Japan

Japan Regulatory Approval Process for Medical Devices

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

Watch our recent webinar on Medical Device Approval in Japan
Japan

WATCH NOW: Japan's Medical Device Approval Process

Learn about the most complex aspects of the Japanese medical device registration process from EMERGO's VP of Business Development.

Japan

Medical Device Change Applications in Japan

In this white paper, we discuss when and how to notify Japan's PMDA about design changes to your device.

Japan

Clinical Data Requirements in Japan

Determining the Japanese clinical data requirements for your device can be challenging. This paper explains PMDA clinical requirements.

Fill out our short form to request information about Japan
Japan

Get smart about Japan in 1 hour

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

Japan

Medical Device Consulting Services for Japan

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

Japan

What To Expect From Your Regulatory Representative

Are you planning to export your device to other medical device markets? Most countries require you to have a physical presence in that market. If you do not have an office there, you can appoint an independent representative to meet this need.