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Resource Library for Medical Device Professionals

Resource Library for Medical Device Professionals

326 total results. Use the filters to narrow down the results.
Learn about the Japanese PMDA regulations which apply to medical devices
Japan

Japan Medical Device Regulations

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

Japan

Japan PMDA - Pharmaceuticals and Medical Devices Agency

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

Japan

Transitioning to Medical Device Single Audit Program (MDSAP) Compliance

In this white paper, we discuss the steps you should follow to achieve MDSAP certification.

Learn about basic demographic and healthcare market data on Japan
Japan

JAPAN – Overview of medical device industry and healthcare statistics

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

Malaysia

Introduction to Malaysia's medical device approval process

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

Malaysia

Registering a Device with the MDA in Malaysia

Learn about Malaysia's medical device and IVD regulations and registration requirements in this white paper.

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

Malaysia Regulatory Approval Process for Medical Devices

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

Malaysia

Medical Device Consulting Services for Malaysia

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

Malaysia

MDA - Malaysia Medical Device Authority

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

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

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.

Learn about the Malaysian regulations which apply to medical devices
Malaysia

Malaysia Medical Device Regulations

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

Mexico

COFEPRIS - Mexico Ministry of Health

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

Mexico

Introduction to Mexico's medical device approval process

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

Mexico | Medical Devices

COFEPRIS Medical Device Registration in Mexico

This white paper discusses the advantages and disadvantages to consider when choosinig a medical device registration route in Mexico.

Mexico | Medical Devices

WATCH NOW: Medical Device Registration in Mexico

In this one-hour recorded webinar, you will learn what it takes to register a medical device with COFEPRIS in Mexico.

Mexico

In Depth: Mexico Medical Device Approval and Compliance

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

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

Mexico COFEPRIS Regulatory Approval Process for Medical Devices and IVDs

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

Mexico

Importing Medical Devices into Mexico

Mexico's importation process is challenging. This white paper explores how to successfully import medical devices to Mexico.

Fill out our short form to request information about Mexico
Mexico

Get smart about Mexico in 1 hour

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

Mexico

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.

Mexico

Medical Device Consulting Services for Mexico

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

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

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.

Learn about basic demographic and healthcare market data on Mexico
Mexico

MEXICO – Overview of medical device industry and healthcare statistics

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

Learn about the Mexican COFEPRIS regulations which apply to medical devices
Mexico

Mexico Medical Device Regulations

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

New Zealand

Medical Device Consulting Services for New Zealand

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

New Zealand

Medical Device Registration in Australia & New Zealand

This white paper answers your biggest questions about how to register your medical device or IVD in Australia or New Zealand.

Learn about the New Zealand regulations which apply to medical devices
New Zealand

New Zealand Medical Device Regulations

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

New Zealand

Medsafe - New Zealand Medicine and Medical Devices Safety Authority

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

Learn about the services Emergo offers for Peru
Peru

Medical Device Consulting Services for Peru

Interested in selling your medical device in Peru? Emergo offers several services for companies looking to enter this market.

Learn about the Peruvian regulations which apply to medical devices
Peru

Peru Medical Device Regulations

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