Resource Library for Medical Device Professionals

This white paper will discuss the requirements for achieving compliance with the Quality Management System (QMS) regulations as they apply in Canada for obtaining a Medical Device License (MDL) under the Medical Device Single Audit Program (MDSAP).

The publication of ISO 13485:2016 introduced significant changes for device manufacturers around the world. Some changes are specific, while others relate to the overall approach to quality management systems for device companies. After watching this video, you will have a better understanding of the most significant changes in the new standard, including how the changes will affect: executive management data, design, and other controls your suppliers your employees You'll also learn when you need to recertify to the new standard and how to plan your transition.

As the first year of its operational phase ends, the Medical Device Single Audit Program (MDSAP) is finally gaining traction among medical device manufacturers. More manufacturers are expected to participate in MDSAP in 2018, particularly as Health Canada’s compliance deadline of January 2019 approaches. This white paper assumes you are aware of the MDSAP’s history and background, and outlines the broad steps for medical device manufacturers to consider in their transition to MDSAP certification and their interactions with recognized Auditing Organizations (AOs). You will learn: Steps in the...

Below you will find basic demographic and healthcare market data on Canada, plus specific information about the medical device and healthcare industries. Overview of medical device industry : Canada has one of the largest economies in the world and the eighth largest medical device market. It was valued at US$6.2 billion in 2015 and is projected to grow steadily, but modestly, increasing to approximately US $8.6 billion by 2020. The Canadian medical device market is sophisticated and mature, with a strong demand for high-quality medical technologies. The majority of medical devices used in...

To see their products to the Chinese market, medical device and IVD manufacturers will need to obtain National Medical Products Administration (NMPA) (formerly China Food and Drug Administration or CFDA) approval. Find out more about the NMPA approval process in China by reading or downloading the chart below.

With over 1.3 billion residents, China has one of the world's largest medical device markets. Medical device manufacturers around the world are intrigued by sales opportunities in China, but the regulatory process can be challenging. Interested in learning how to tap into this market? This short video tells you how. Topics covered include: Chinese regulatory structure How to determine the classification of devices in China In-country representation Testing and clinical evaluation requirements Quality system verification requirements Registration dossier components and more

Thinking of selling your medical device in China? If so, you need to register your device with China's regulatory authority, the China Food and Drug Administration (CFDA), now the National Medical Products Administration or NMPA. The NMPA has strict regulatory requirements, especially for foreign manufacturers who want to import their products to China. It's important to understand the requirements before you begin the registration process. In this white paper, we'll answer your biggest questions about what it takes to start selling your medical device in China. You will learn: steps in the...

Below you will find basic demographic and healthcare market data on China, plus specific information about the medical device and healthcare industries. Overview of medical device industry : China's economic growth is slowing down, but the medical device industry is still on the rise. The Chinese medical device industry was valued at US$18.8 billion in 2016 and is projected to grow modestly through 2019, when it should reach over US$24 billion. The Chinese medical device market is buoyed by the increasing demand for high-tech medical device imports to treat chronic and age-related disease...

To market a medical device or IVD, manufacturers must register with the National Food and Drug Surveillance Institute (INVIMA), the country’s medical device regulator. With a four-tiered classification system, the classification scheme is very similar to those of the European Union. See an overview of the INVIMA approval process below or download the regulatory chart.

All Colombia medical device regulations listed below are in PDF format. Please help us maintain this list by reporting outdated or missing documents. If you need help determining the regulatory requirements for your medical device in Colombia, you may be interested in our custom regulatory strategy reports for Colombia.

Medical device manufacturers who want to enter the Costa Rican market need to obtain approval from the Costa Rican Ministry of Health. There are a few pathways to approval, and documentation requirements are different depending on your device's class. To see the differences between the classes, and to find out more about the medical device approval process with the Costa Rica Ministry of Health, please see or download the chart shown.

All documents were published by the Costa Rican Ministry of Health and are in PDF format. The Costa Rica Ministry of Health updates their database of approved devices on a monthly basis: Costa Rica Ministry of Health database of approved devices (in Spanish).