中国国际医疗器械设计与制造技术展览会(Medtec China)2021

Dedicated to design & manufacturing for medical device

December 7-9 2022 | Suzhou lnternational Expo Centre B1-E1

Policies & Regulations

2022.08.15
State-of-the-Art:Unpacking MDR’s Evolving Requirements
Per EU MDR regulations, any medical device on the market must be considered “state-of-the-art.” However, the term is not explicitly defined. Exploring MDR verbiage around standards harmonization, risk management and clinical data may allow a clearer understanding of regulatory expectations to emerge.......



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2022.08.04
FDA eases UDI compliance requirements for some low-risk medical devices
The U.S. Food and Drug Administration has exempted low-risk medical devices considered consumer health products from some Unique Device Identification compliance requirements in accordance with least burdensome principles......
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2022.07.13
Would the New CMS Rule Harm Medtech?

Centers for Medicare and Medicaid Services (CMS) unveiled its 2023 payment proposal. Here's how it would impact some medical device companies and sectors......



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2022.06.27
A Haystack with No Needle: Is an Extractables Study Appropriate for Limited-Contact Devices?
Based on ISO 10993-18, some medical device manufacturers to wonder if an extractables study is required for all devices, regardless of duration of contact. Experts at Nelson Labs share their knowledge on the matter......



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2022.05.31
In Vitro Diagnostic Medical Devices Regulation Takes Effect
The deadline impacts new devices but amended regulation grants most IVDs (depending on their risk class) three to five more years to comply......



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2022.05.23
Exploring Valve Technology Requirements Under the New MDR
Among the many standards and regulations affecting the medical device industry is the European Parliament (EU) 2017/745 standard, also known as the Medical Device Regulation......



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2022.04.28
Moody’s warns of cybersecurity, antitrust and supplier risks for medical device companies
Medical device companies face heightened cybersecurity burdens, antitrust enforcement and supplier risks, according to a new report out of Moody’s.......



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2022.04.22
Assessment of Medical Devices Without Animal Experiments

To ensure patient safety, regulations such as the EU Medical Device Regulation require risk assessments to be conducted for all medical devices, including biological evaluation in accordance with ISO 10993. This article explores how manufacturers can have their products assessed efficiently without animal experiments......



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2022.01.25
Extended Transitional Provisions for EU’s IVDR Expected Rather than a Delay

Revisions to the IVDR’s transitional provisions may grant some IVD manufacturers extra time for compliance, but there is much work to do......



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2022.01.10
Medtronic Recalls Synergy Cranial and Related Software Due to Glitch
Medtronic is recalling its Synergy Cranial and StealthStation S7 Cranial software due to the risk of potential inaccuracies......



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