Second Corrigendum by EU MDR grants grace period for some self-certified Class I medical devices
The European Parliament adopted the second corrigendum of the Medical Devices Regulation (EU) 2017/745 (MDR)pg 44 of 145 for English, with significant compliance deadline implications for some currently self-certified devices. This change suggests that devices (not custom made devices) that are self-certified Class I under the current Medical Devices Directive 93/42/EEC (MDD) but that will be […]
US FDA issues detailed Framework for the Safety and Performance Based Pathway for abbreviated 510(k) medical device review
As a first step towards operationalizing of the Safety and Performance Based Pathway, the FDA has issued draft guidances identifying performance criteria and testing methodologies for certain devices within five class II device types. The FDA expects to operationalize this pathway once the first device types and applicable performance criteria have been identified and final […]
ANVISA: Reached milestone of 5000 international health product certifications using MDSAP in 2019
Brazilian medical device market regulator, ANVISA, according to a recent report showed a significant increase in medical device manufacturers participating in the Medical Device Single Audit Program (MDSAP), with nearly half of all quality management system certifications issued in 2019 under MDSAP. According to the report, the Medical Device Single Audit Program (MDSAP) reached, in […]
Ministry of Food and Drug Safety Korean reduces submission requirements for high-risk devices
South Korean MFDS have reduced the registration submission requirements for Class-IV medical devices. This noticeis expected to reduce submission preparation timeframes for Class IV device applicants, and potentially eases South Korean market entry. As per the noticefrom MFDS, manufacturers of Class IV devices will no longer be required to prepare and submit full Summary Technical […]
Singapore Health Sciences Authority: new guidance on special authorization routes for unregistered medical devices
The Singapore Health Sciences Authority (HSA) has issued new guidance on Special Authorization Routes (SARs) for the unregistered medical devices in the country. These SARs allow qualified healthcare providers in Singapore to utilize unregistered devices in case of emergencies, or when more conventional therapies have proven unsuccessful.The new guidance covers application processes, requirements and post-market […]
MHRA explains role of UK responsible person
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) have published new details on the role and responsibilities of the UK Representative if a no-deal Brexit withdrawal from the European Union comes to pass. The updated guidancedocument explained the rules of how non-UK manufacturers could place their devices on the UK market. The manufacturers would have to […]
US FDA: guidance for abbreviated 510(k) programs finalized, updates Refuse to Accept policy
The US FDA’s Center for Devices and Radiological Health (CDRH) has issued final guidance for its Abbreviated 510(k) premarket notification pathways following proposals in 2018 to expand access to these programs, as well as its Refuse to Accept policy for inadequate or incomplete 510(k) submissions. Abbreviated 510(k) program for faster FDA clearance FDA and CDRH […]
USFDA updates on hike in user fees for the 2020 fiscal year
US Food and Drug Administration medical device have increased the user fees by about six percent for 510(k) premarket notifications, Premarket Approvals (PMAs) and other market registration applications for the 2020 fiscal year. FDA’s user fee schedule for 2020 shall take effect from October 1, 2019, and entails six-percent increases for both standard and small-business rates. The […]
TGA have implemented the cybersecurity regulatory recommendations:
Australia’s Therapeutic Goods Administration (TGA) has implemented the final guidance on pre- and post-market cybersecurity regulatory recommendations for medical device, software and IVD manufacturers and sponsors. The TGA guidance applies to software as a medical device (SaMD) as well as medical devices and IVDs incorporating components that may be vulnerable to cyber threats. The TGA guidance aligns […]
Four organizations designated as UDI Issuing Agencies by EC
The European Commission has designated four organizations as Unique Device Identification (UDI) Issuing Agencies to support medical device and IVD manufacturers comply with new regulatory requirements applicable for Medical Devices under the Medical Devices Regulation (EU) 2017/745 (MDR) and In-Vitro Diagnostic Medical Devices (EU) 2017/746 (IVDR). These agencies will issue the unique codes necessary for […]
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