Wednesday 24 January 2018

Device Approval

Guest Editorial: How Chinese Medical Device Manufacturers are Entering Western Markets

February 28, 2012 | 2 comments

How Chinese Medical Device Manufacturers are entering Western Markets Guest Editorial: Dr. Camilla Storaa  The Chinese economy has grown to be […]

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New Jersey Company Agrees to Halt Production of Unapproved Dental Devices

February 14, 2012 | No comments

The US Food and Drug Administration announced a consent decree with a NJ company to halt the production of an unapproved medical […]

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EC’s Commissioner for Health and Consumer Policy Calls for Stricter Safety Controls, Postmarketing Surveillance for Medical Devices

February 10, 2012 | No comments

The European Commission’s (EC) Commissioner for Health and Consumer Policy John Dalli called for the EC to “look at the […]

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Perfect Image Solutions, LLC Issues Voluntary Recall – A Lesson in Reviewing Regulations Before Marketing and Selling

January 20, 2012 | 2 comments

Skipping the regulatory review of a new product to determine whether its FDA regulated comes with consequences as the FDA […]

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EC Looking to Recommend Tougher Regulations on Medical Devices, More Member State Coordination

January 20, 2012 | No comments

New changes are emerging from the French scandal involving breast implants. The European Commission (EC) will investigate whether or not […]

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CDRH Issues Draft Guidance on Substantial Equivalence Determinations

January 3, 2012 | No comments

The Center for Device and Radiological Health (CDRH) is the branch of the FDA responsible for managing premarket approval of […]

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Overview of Medical Device Approval in Mexico (COFEPRIS Certification)

December 12, 2011 | No comments

Medical device, including IVDs, face the challenge of gaining pre-market clearance in a variety of countries with regulatory frameworks that […]

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FDA Offers New Guidance for Artificial Pancreas Device Systems

December 1, 2011 | No comments

The FDA issued new guidelines on Thursday for the development of a potentially revolutionary device to treat type 1 diabetes […]

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Getting Started with a New Medical Device

November 30, 2011 | No comments

This question often pops-up in a first meeting with clients who have invented a new medical device: do I have […]

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FDA Extends Comment Period on 510(k) Guidance

November 14, 2011 | No comments

The FDA has extended the public comment period for its draft guidance on medical device 510(k) clearance for modified devices. […]

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