STARK BLOG
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 […]
NMPA China begins laying groundwork for UDI Pilot program
National Medical Products Administration (NMPA), China, has begun laying the groundwork for a Unique Device Identification (UDI) pilot program scheduled to run through July 2020.NMPA will carry out the pilot in collaboration with the National Health Care Security Administration (NHCSA) as well as the National Institutes of Medical Device Standards Management. Medical device manufacturers will create UDI numbers […]
Happy 4th July-2019
Celebrate the spirit of Independence. We wish you safe and happy 4th of July from Stark Associates.
Factsheet released by EC: prediction on possible failure of manufacturers in meeting compliance deadlines
European Commission advises a new factsheet for healthcare providers and institutions for healthcare providers and institutions to prepare for possible shortages of some medical devices and IVDs if the manufacturers do not meet compliance deadlines for the Medical Devices Regulation (MDR) and In-vitro Diagnostic Medical Devices Regulation (IVDR). The factsheet cites several issues pertaining to […]
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 […]
USFDA defines Test Plan for Digital Health Software Precertification (Pre-Cert) Program
The FDA is seeking test cases from software organizations planning to submit a De Novo Request or 510(k) submission for software as a medical device (SaMD) in 2019 or shortly thereafter to meet the goals of the Test Plan. The FDA’s request for test case submissions follows the rollout of the Pre-Cert program’s test plan earlier in 2019 establishing processes […]
Guidance on Unique Device Identification (UDI) system in Saudi Arabia
The Saudi Food and Drug Authority (SFDA) has issued guidance on establishing a Unique Device Identification (UDI) system in Saudi Arabia. The guidance covers all medical devices and accessories registered in Saudi Arabia, with the exception of custom-made devices as well as investigational medical devices and IVD devices. The UDI requirements listed by SFDA, generally in line […]
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