European Commission enacts new rules concerning Notified Bodies

Louise Zornoza reports on that on September 24, 2013, the European Commission issued new rules creating a new EU process for designating and monitoring Notified Bodies. The new rules establish the basis for withdrawal and clarify the required expertise of these groups. Notified Bodies are responsible for the oversight of local manufacturers of medium and high risk medical devices. There are currently 80 Notified Bodies in the European Union, which all conduct audits and issue CE markings for medical devices. The new rules describe the designation of a Notified Body as well as the monitoring of such body to reaffirm its compliance and use. For the full article and new rules, click here.

Brazil: ANVISA beginning to update and revise regulatory system

Stewart Eisenhart, of, explains that Brazilian medical device regulator ANVISA is planning a multitude of updates and revisions to Brazil’s existing regulatory system to be enacted by the end of 2014.  These proposed changes will affect almost all quality management system requirements and registrations currently in place.  Although none of the alterations have been enacted yet, the announcement of a list of medical device and in vitro diagnostic issues targeted displays ANVISA’s plan is coming to fruition. If all the changes are to be enacted by the end of 2014, Brazil will have more efficient, cost effective market access for foreign manufacturers. Do you think Brazil could begin to be a major player in foreign manufacturing in the next five years? For the full article click here.

MedTech growth in Latin America not slowing down

Latin America has become one of the fastest growing medical device markets due to the high amount of medical OEMs and suppliers entering the area for cost advantages. Chris Wiltz, of, reports that the areas medical technology market is already worth $10.5 billion and is on a path to reach $20 billion in 2015. Latin America offers an area of skilled workers, a large customer base, and an even larger budding economy.  As the graph below shows, the exponential growth has led to a combined GDP per capita that is over 10,000 times as large as the economy. Where do you think the ceiling is for MedTech in Latin America? Read the full article here.


China simplifying process for efficiency

Stewart Eisenhart, of, reported that the China Food & Drug Administration (CFDA) is moving forward with improvements to their classification of medical devices process and is simplifying the road to the market for innovative devices. China has a three point plan to finish this project. First, create an online medium for medical device manufacturers to request regulatory validation of their product classification if they are unsure of its classification. In the past, it was purely a written process. Second, there will now be exemptions to the China Compulsory Certification (CCC) Mark certification that applies more to automotive, wireless, and consumer products. There will be only eight categories that will be exempt from the CCC. Finally, according to China Briefing, a new approval process can push new innovative devices into the market much quicker by having special circumstances and priority status to the review board. Will China be at risk with a less stringent path to market for innovative devices? Read the full article here.

First quarter medical deal declines may not reflect the state of the M&A industry

In a recent article on, Brad Perriello shares interesting data from Pricewaterhouse Coopers’ (PWC) US Pharmaceutical and Life Sciences Deals Insights Quarterly report Medical device mergers and acquisition deals in the first quarter fell from eight in the Q1 of 2012 to seven in Q1 of 2013. The same time comparison had the total value dropping from $2.3 billion down to $1.7 billion. Dimitri Drone from PWC purports that this decline is not necessarily reflected of the true deal activity. Active and not yet closed deals are not included in these numbers and Drone says “There’s a lot of talk about M&A among the people we interact with in medical devices.” The report still forecasts a growth overall in medical device M&A activity for 2013. What do you think?  Are you seeing more of an appetite for deals? To review the PWC report, click here, and for the full article click here.

New study finds that physicians contribute to discovery of new medical devices

A recent study published in the May issue of Medical Care found that medical device startup companies founded by physicians developed roughly the same number of patents as non-physician founded startups. The study, conducted by Drs. Sheryl Winston Smith, PhD and Andrew Sfekas, PhD of the Fox School of Business at Temple University, focused on high-risk, class III medical devices which require substantial testing to prove safety and effectiveness.  The study used an algorithm to examine the overlap between premarket approval applications and patents, which is important for identifying which patents are more important for developing new ideas. However, the researchers indicated that conflict of interest policies may result in fewer startups, if regulations are too tight. To read the full article on, click here.

FDA suggests international consortium of cardiovascular registries

FDA is calling for an international consortium of cardiovascular registries to coordinate data from multiple disease registries for use in testing the efficacy and safety of medical devices per a recent article on Patient registries have been used in the past to help regulators manage data from common diseases, as well as gather information to help guide clinical trial expectations. FDA’s international cardiovascular consortium model is based on the International Consortium of Orthopedic Registries (ICOR), which also links various member registries. According to FDA, the registry would serve to “allow for broad-based analysis and surveillance of medical device exposure and related clinical outcomes.” FDA is planning to hold a workshop to gain public input on the proposal and discuss how to implement the plan. To read the full article on, click here.

What do you think of the FDA proposal? Contact us at 317-899-9341 for help with your clinical trials.

Repeal of the medical device tax gains Congressional support

On April 9, 2013, Stephen J. Ubl, president and CEO of AvaMed praised Congress for supporting the repeal of the medical device tax. Ubl stated that device manufacturers are paying an estimated average of $194 million per month in medical device payments, and the tax payments could potentially take money away from R&D for new products and new jobs. To read more of Ubl’s statement, click here. Contact us at 317-899-9341 for help with medical device regulatory filings.

FDA to issue guidance on mobile medical devices

According to a recent article on, the FDA plans to issue guidance describing which medical apps on mobile devices will be subjected to FDA approval. With the advent of multiple new medical apps, the FDA plans to regulate mobile devices that perform jobs done by medical devices that already require FDA clearance or approval.  According to Christina Foreman, director of the FDA’s device evaluation division, the goal of the regulation is to “foster technological innovation,” while ensuring that the apps are safe for the public. The FDA does not plan to regulate wellness apps, such as pedometers or heart-rate monitors. To read the full article, click here.  Need help getting your medical device approved? Contact us at 317-899-9341.

Health Canada issues a medical device final rule

Health Canada issued guidance on March 4, 2013 entitled “Factors Influencing the Classification of Products at the Device-Drug Interface” which finalizes the guidelines for classification of therapeutic devices or drugs. The focuses of the guidance were to clarify what constitutes a drug or device and support a more standardized regulatory process. To read the final guidance, click here.  Contact us at 317-899-9341, if you need assistance with your medical device submission.