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Immediate improvements sought in EU-wide surveillance of medical devices post-PIP
03 February 2012
The European Commission is looking at "immediate measures" to improve the surveillance of medical devices within the existing legal framework in light of the sub-standard PIP breast implants affair. The commission will launch a discussion with all ...
 
US FDA sets 30 June deadline for finalising companion Dx guidance
26 January 2012
The US FDA's guideline on the development of companion diagnostics is expected to be finalised by 30 June, the agency has announced in a document outlining its medical device unit's strategic priorities for 2012. A draft version of the guideline, ...
US FDA misses deadline for submitting device user fee proposal to Congress
24 January 2012
The US Food and Drug Administration has missed its 15 January deadline for submitting a plan to Congress on how much user fees the medical device industry should pay the agency to evaluate its products in fiscal years 2013-2017. The FDA's current ...
 
PIP breast implants sold in 71 countries, not 66, according to French report
02 February 2012
The French government has published a comprehensive report on the history, current situation and implications of the crisis involving fraudulent silicone breast implants made by the now-defunct Poly Implant Protheses (PIP). Among the most ...
Spanish medtech sees debt relief ahead, "but solution increasingly urgent"
02 February 2012
Spanish medtech industry association Fenin has cautiously welcomed plans being drawn up by the recently-installed government to tackle the country’s burgeoning national and regional budgetary problems. However, citing the latest debt and late ...
 
Mexico tightens control of unapproved healthcare products
30 January 2012
Mexico is introducing legislation to tighten the control of products advertised and sold as healthcare-related but which have not been approved as such. A presidential decree amending the General Healthcare Law, the main national legal instrument ...
Brazil sets new standard in PIP follow-up; major replacement network ready
26 January 2012
Brazil’s health ministry has published comprehensive technical guidance on the follow-up of PIP and Rofil-rebranded PIP silicone breast implants, together with a list of almost 400 clinics that have been designated to undertake the replacement ...
 
China to regulate cosmetic contact lenses as Class III devices
24 January 2012
China is to regulate non-corrective coloured contact lenses as Class III (highest-risk) medical devices. The State Food and Drug Administration is expected to issue a notice on the matter shortly, specifying the date from which these lenses may not ...
Less investment but more value for Singapore biomedical sector last year
23 January 2012
While Singapore saw a sharp fall in investment commitments in the biomedical manufacturing sector last year, these have shifted to operations and products that are expected to add more value to the economy in the future, the latest figures from the ...
 
Kenya issues guidance on marketing devices and devices
01 February 2012
The Kenyan Pharmacy and Poisons Board has issued guidance explaining the current minimum requirements for advertising and promoting drugs and medical devices in the country. The guideline stipulates, among other things, the procedures that ...
Saudi FDA updates guideline on device marketing authorisation procedures
12 December 2011
The Saudi Food and Drug Authority has updated its guidance on medical device marketing authorisation procedures to clarify, among other things, the requirements for cases where more than one device type is grouped or bundled in a single application ...
 
Softening CRM sector in need of more pace and rhythm
03 February 2012
Ashley Yeo

Cardiac rhythm management remains a $2bn business at Boston Scientific , but a 15% slide (in both reported and constant currencies) in sales in the final quarter of 2011, reported yesterday, meant that the group’s second-largest business unit ...

 
“Saudi spring” 2012-style signals new growth for medtech
24 January 2012
Arab Health 2012, the largest healthcare exhibition in the Middle East, is currently in full swing at the Dubai World Trade Centre, UAE. Organised by Informa Exhibitions ( http://www.arabhealthonline.com/home/ ), the event runs from January ...
 French medtech entrepreneurialism needs infrastructural back...   Off-label promotion: how to avoid falling foul of the US FDA...
Advanced Therapies: is the EU regulatory approach putting a brake on market development?
19 January 2012
There is no doubt that the European Medicines Agency's Committee for Advanced Therapies (CAT) has put considerable effort into developing a significant number of guidelines to explain how it operates in the complex field of advanced therapy ...
PIP and EU regulatory system in the spotlight
06 January 2012
The Poly Implant Prothèse (PIP) scandal has led to concerns about ruptured implants, worries over associated cancer (unfounded) and generally irritating or debilitating effects of the silicone’s leakage into the body. It has also put medical device ...

Advanced Therapies: is the EU regulatory approach putting a brake on market development?
19 January 2012
Amanda Maxwell

There is no doubt that the European Medicines Agency's Committee for Advanced Therapies (CAT) has put considerable effort into developing a significant number of guidelines to explain how it operates in the complex field of advanced therapy ...

 
Clinica 100
28 October 2011

This year's Clinica 100: Analysis of the Medtech Industry is now out with the December issue. This special 24-page section features: - Clinica League Tables - Top 100 medtech companies and Top 20 Sector Leaders - Interviews offering insight into ...

 
EVENTS
The 14th MedTech Investing Europe conference
19 March 2012
Montreux Convention and Music Centre, Switzerland
HTAi 2012
23 June 2012
Bilbao, Spain
 
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