As medical device quality assurance and regulatory affairs professionals, it can be challenging to stay on top of changes happening in our industry. Few people have the time to read lengthy articles these days and although many online newsletters exist, they are often packed with PR releases, ads or unrelated information. That is why we started this blog for QA/RA professionals in the medical device and IVD industry. The idea is to give you short updates on quality and regulatory topics that may be of interest to you.

2011年 12月 19日

China Allows Clinical Trial Waivers for Some Class II Medical Devices

Update 12/20/2011: According to Emergo Group sources in Beijing, the waiver policy was instituted by the Beijing FDA (BFDA) rather than the SFDA. Furthermore, the policy applies only to domestic medical devices in China, not imports.
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2011年 12月 19日

New FDA Guidance Emphasizes Gender Differences in Clinical Studies

New draft guidance from the US Food and Drug Administration recommends improvements to medical device manufacturers’ clinical study designs in order to better assess safety and effectiveness of their products according to gender.
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2011年 12月 19日

CMC Decision on Labeling, EC Translation & Croatia in the EU

As 2011 winds down, we write you with some final news for the year from the European Union.
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2011年 12月 14日

FDA Guidance on HUD Designations Out for Comment

The US Food and Drug Administration has opened a 90-day comment period for
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2011年 12月 14日

UK Unveils Long-term Telehealth Campaign

The UK Department of Health has undertaken a campaign to expand the use of mobile medical devices and services to cover three million patients over the next five years.
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2011年 12月 13日

Moody’s: US Medical Device Firms Face Soft Organic Growth Prospects

US medical device manufacturers dealing with lower market demand and rising pricing pressure will rely more on acquisitions and stock maneuverings to offset challenging growth prospects.
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2011年 12月 12日

New Position Paper Urges Greater Industry Role in HTAs

In a new joint position paper, European medical technology associations are arguing for
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2011年 12月 7日

Indian Regulators Moving Ahead with Medical Devices Bill

India’s health ministry plans to push forward its proposed amendments to the country’s Drugs and Cosmetics Act that would
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2011年 12月 6日

New US Reimbursement Policy Targets Some Medical Devices

A new Centers for Medicare & Medicaid Services (CMS) policy going into effect early next year will require prior authorization for some medical devices and equipment for Medicare patients in seven US states. The new policy will also require pre-payment of reimbursement claims for some medical devices across 11 US states.
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2011年 12月 2日

GOST-R Certification Replaced & Draft Proposal for Regulatory Overhaul

In addition to new regulations implemented earlier last year, the regulatory system in Russia is poised for a fairly significant update with the expected implementation of the “Administrative
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