Regulatory authorities respond to medical device market growth

The growth of medical devices global market up to $398 billion by 2017 (by 19,3% compared to 2012 figures) is expected according to Visiongain business intelligence company recent report.

Development of personalized medical management will support steady market growth until 2023.

Regulatory authorities throughout the world responded to the trend and have been publishing new guidances and requirements in this area lately.

Environment, Public Health, and Food Safety (ENVI) committee, a subdivision of European Parliament, released new medical device and in vitro diagnostic regulations in June 2016. The document defines current European requirements for manufacturing, clinical testing, authorization and post-marketing evaluation of medical devices.

Furthermore, European Association of Authorized Representatives (EAAR) is also working on the issue, and their next regular symposium on the new draft regulations on medical devices will take place in Prague and is scheduled for 07 Nov 2016.

FDA released the final version of guidance on reporting of computational modeling studies in medical device submissions in September 2016. This final guidance was long-awaited by industry since its draft version was available in January 2014.

Russian MoH caught up the trend and published the draft version of the rule on technical and practical documentation requirements in medical devices registration dossiers.

Last but not least, last week FDA released the document that describes studies and criteria required for premarketing evaluation of self-monitoring blood glucose test systems.

Considering intense competition on the Russian market of glucometers, the industry might face some additional regulatory rules from Russian MoH.

Sources: 

http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm381813.pdf
http://raps.org/Regulatory-Focus/News/2016/06/15/25142/EU-Council-and-Parliamentary-Committees-Sign-Off-on-New-Medical-Device-IVD-Regulations/
http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM380327.pdf
https://www.visiongain.com/Press_Release/498/%E2%80%98The-global-medical-devices-market-will-reach-398-0bn-in-2017%E2%80%99-predicts-new-visiongain-report
http://www.consultant.ru/law/hotdocs/47593.html
http://informarket.ru/research/rossiyskiy_rinok_sredstv_kontrolya_saharnogo_diabeta.pdf
http://rmd2016.com/