Regulatory & Compliance Perspectives
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Medtech In Chile: Currently Latin America’s Easiest Market, But For How Long?
6/16/2021
The total market size of the medical device sector in Chile is about $1.7 billion and has grown a whopping 75 percent since 2017. The nation imports most of its medical devices, and it currently has the easiest regulatory hurdles for medtech in Latin America. However, you should prepare for the upcoming bill that may impact regulation.
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The “Resiliency Roadmap” — Next Steps For FDA Inspections
6/11/2021
More than a year into the COVID-19 pandemic and FDA’s abrupt suspension of on-site inspections in March 2020, the agency released the Resiliency Roadmap for FDA Inspectional Oversight in May 2021. This article examines how this news affects the pharmaceutical, biotech, and medical device industries.
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The Role Of The Contract Manufacturer Under The EU MDR & IVDR
5/31/2021
As of May 26, 2021, medical device companies must now comply with the EU's Medical Device Regulation (MDR) requirements, and the In Vitro Diagnostics Regulation (IVDR) requirements are effective in May 2022. This article examines the role of the contract manufacturer under these regulations.
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FDA’s Safety And Performance-based Pathway: An Alternative To Substantial Equivalence For 510(k) Submissions
5/26/2021
The FDA's 510(k) clearance of medical devices is based on proven substantial equivalence with claimed predicate device(s). In concert with the goal of adopting the least burdensome approaches, the FDA provides an alternate pathway based on proven safety and performance characteristics, instead of devices’ equivalence to other predicates.
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ISO 10993-23: The “Step-Wise” Approach To Evaluate Potential Irritants In Medical Devices Becomes Effective
5/12/2021
The new ISO 10993-21:2021 specifies the procedure for the assessment of the biological irritating potential of medical devices, materials, or their extracts. It is relevant to all directly or indirectly contacting medical devices regardless of the nature and duration of body contact.
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Not A Time For Novices: FDA Needs A Leader With Deep Agency Roots And Expertise
5/5/2021
With the crossing of President Biden's 100th day in office, the administration still hasn’t nominated an FDA commissioner candidate, a delay that daily weakens the FDA and undermines the agency’s ability to act boldly and decisively in order to face the challenges caused by the pandemic and its aftermath. This article makes the case for what traits we need to see in an FDA leader and who would fit the bill.
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Are You Ready For The FDA’s “Data Effect” Tsunami? 8 Steps To Prepare
5/5/2021
The FDA is moving forward with its Data Modernization Action Plan, the next leg of the Technology Modernization Action Plan. As such, you'll need to prepare yourself for the influx of questions, audits, observations, warning letters, and more. Here's what you can do to position yourself for success.
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A Road Map To China’s Medical Device Registration Process
4/28/2021
China has one of the most promising medical markets and its healthcare industry is currently the second largest in the world. How do you register your device there with the proper authorities? The pre-market or product registration procedures are different for imported products and local domestic products.
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The Top 10 Most-Cited Issues In FDA FY2020 Medical Device Inspections
4/26/2021
The first article in this series discussed the background and a few high-level observations of the FDA’s summaries of its medical device quality system inspections. This article digs into the details of the FY2020 observations. What were the top 10 most-cited issues, and what are the takeaways you can implement?
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How To Navigate Clinical Data Per EU MDR
4/7/2021
The EU MDR puts a higher emphasis on clinical data for medical devices and calls for increased scrutiny on the duty of manufacturers to continuously collect clinical data in the postmarket setting. Matthias Fink, MD, of TÜV SÜD America explains the MDR requirements surrounding clinical data.