Act Now to Prepare for MDSAP Audits
The clock is ticking for medical device manufacturers worldwide. Manufacturers that want to continue selling products in Canada’s $6.7 billion medical device market should be preparing and planning for the international Medical Device Single Audit Program (MDSAP) by now. Canada is the first market to require the MDSAP audit as part of its medical device licensing scheme, beginning Jan. 1, 2019. On that date, companies selling Class II, III, and IV medical devices and IVDs must have an MDSAP Certificate on file with Health Canada to maintain their Canadian Device Licenses.
FDA Exempts Over 1000 Devices from 510(k) Requirement
The 21st Century Cures Act paved the way for deregulation of a host of medical devices ranging from surgical lights to dentures.
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4 top regulatory issues to watch in 2017
This is shaping up to be a big year when it comes to medtech regulation, as well as regulations for other types of life science companies.
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FDA Proposes Ban on Powdered Gloves After Years of Review
In a rare move, FDA has proposed banning most types of powdered medical gloves in the United States. Some say the decision took too long.
What You Need to Know: IEC 60601-1-2 4th Edition
An expert discusses what medical device manufacturers need to keep in mind as the compliance date for the fourth edition of the IEC 60601-1-2 standard approaches.
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510(k) Tips for Antimicrobial-Treated Devices
Manufacturers should familiarize themselves with seven important FDA requirements for 510(k) submissions for these products.
2016 FDA Guidance Documents You Should Know
These were the most important guidance documents of the year for medical device manufacturers.
4 Tips for a Smooth 510(k) Submission Process
As you are probably aware, a 510(k) submission is required in order to get FDA market clearance for nearly all Class II devices.
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10 Biggest Medical Device Recalls of 2016
2016 was a big year for medical device recalls, with the number of units recalled in the third quarter reaching the highest level in four years. Here are the 10 recalls that impacted the most medical device units in the United States.
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Two Big Moves at FDA
FDA launched two major initiatives in 2016—cybersecurity requirements and a national system for real-world device monitoring.
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