Worldwide Medical Device Regulatory Updates

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.

Health Canada Clarifies Performance Targets, Reports Decline in MDL Submissions

Health Canada’s intake of Medical Device License (MDL) applications has shown a slow but steady decrease in the regulator’s number of license approvals from 2011 to mid-2016.

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US FDA Urges National Device Evaluation System Incorporating UDI

Top US Food and Drug Administration officials are pushing for implementation of a national system for evaluating medical device pre- and post-market data including Unique Device Identification (UDI) to better address safety and effectiveness issues for patients and users.

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Brazilian Regulators Allow More Flexibility for Device Registration Transfers, Extend Tech File Deadline

Brazilian medical device market regulator ANVISA has signaled that a new regulation providing more flexibility for transferring medical device registrations between holders.

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MEDDEV 2.7/1: A Closer Look at Updated Guidance on European Clinical Evaluations

Following the release of MEDDEV 2.7/1 with updated guidance on clinical evaluations in Europe, Emergo takes a deeper dive into some of the new version’s recommendations and their impacts on medical device manufacturers.

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Final FDA Guidance Issued on Medical Device Electromagnetic Compatibility

US medical device market regulators have finalized guidance on how manufacturers of electrically powered devices should prove electromagnetic compatibility (EMC) for premarket clearance or approval.

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New MEDDEV on European Clinical Evaluation Reports: A Broader Scope

Revised European guidance on Clinical Evaluation Reports (CER) for medical devices takes a more comprehensive approach to total-product-lifecycle issues and introduces more thorough pre- and most-market data requirements.

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In Brief: Brazil’s ANVISA Updates Modification Process for Lower-risk Cadastro Devices

Brazilian medical device market regulators have eased requirements for making changes to lower-risk or cadastro registrations for medical devices and IVDs.

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India Issues Draft Medical Device Regulations Separate from Drug Law

Indian medical device market regulators have released new draft regulations following the government’s recent announcement that it would scrap the Drugs and Cosmetics (Amendment) Bill of 2013 in favor of separate laws for drugs and devices.

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MDR Analysis: Does your medical device fall under the scope of new European regulations?

Now that the European Medical Device Regulation (MDR) is widely available in draft form, manufacturers and other industry participants can more accurately predict key issues that will affect them—including how and whether the scope of the new regulations covers their devices.

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Corrections to Australian Government’s Prostheses List have Reimbursement Implications

The Australian Department of Health recently issued several corrections to its list of prosthetic medical devices used to determine reimbursement rates from private health insurers in the country.

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