News: Medical e-News Round-Up - Issue 47

This issue covers:

Market report charts growth of medical devices

A specialist industry report looks at growing demand for medical devices. The ‘Europe Medical Device Market Outlook to 2018’ provides a comprehensive analysis of industry aspects including, market size by production value of medical devices market in Europe.

The demand for medical devices has been growing owing to a mounting awareness for early diagnosis and treatment of countless disease states in European countries. Other factors propelling the escalating demand for medical devices are the ageing populace, growth in the number of better informed patients and the accessibility of enhanced technologies.

The report also entails market share analysis and company profiles of major players operating in the medical devices market in Europe. A future analysis, trends and developments, government regulations and segmentation by application have also been discussed in the industry research report. Full details are available here.

Growth in Chinese medical device regulatory framework

As China's medical device market rapidly develops, the China Food and Drug Administration (CFDA) is working quickly to update its standards and certification framework.

It is reported that recently, the CFDA issued a further 90 industrial standards for medical devices. Of these, 14 are to be mandatory standards and will come into effect on 01 January 2017. The remaining 76 recommended industry standards include medical electrical equipment and equipment for dentistry and will come into effect on 01 January 2016.

These new 90 standards are in addition to the 120 industry standards already announced in July 2014 and bring the total number of medical device standards to over 700.

With an estimated value of over $17-billion the Chinese medical device market is the world's fourth largest with many opportunities for overseas companies.

Although most of the guidance is similar or equivalent to the European harmonised standards, careful attention must be paid to the version adopted and any local variations. The full article on China’s growing regulatory framework is here.

International medical device standards explained

One common source of misunderstanding in the medical device industry is the method the various national regulatory systems use to identify standards.

An informative article on MedDevice Online explains the classification system for medical device standards and how the various regulatory bodies in different countries work together across international boundaries.

The article explains how a particular region or country has a standards organisation that may adopt an international standard, and in some cases they modify it or place limitations on it. In addition, the medical device authorities in the region or country may recognise the standard, but there is no obligation to do so. The situation in the USA, European Union and Canada is used to illustrate these points. More details here.

New German website for Rigel

Rigel Medical German language website is now up and running, providing further support for its international customers through added value resources and online tool-kits.

www.rigelmedical.de provides sections covering the company’s range of advanced electrical safety analysers and vital signs simulators along with technical datasheets and brochures. Additional guides and manuals will be available in future as the website expands and develops further.

The site includes enhanced search and navigation features providing ease of access to in-depth information on the Rigel range and help users to identify the right electrical safety tester for their requirements. Users can contact Rigel Medical direct for enquiries on all products and register to receive a regular e-mail newsletter giving details of new instruments and technical developments as they are announced.