Australia’s Therapeutic Goods Administration publishes guidance on clinical decision support software exemptions
Australia’s TGA is currently reforming the regulation of software-based medical devices, with an amendment that introduces significant regulatory carve-outs taking effect this week after being postponed due to the COVID-19 pandemic. In support of the changes found in the amendment, the TGA has published guidance on the regulation of clinical decision support software (CDSS) on its website. This guidance document has been […]
Stark Associates bags a COVID-19 based R&D and Regulatory Submissions Contract for a US Medical Device Manufacturing Co.
Stark Associates announced winning a strategic contract to support Research & Development for COVID-19 protective gear along with regulatory submissions for a Louisville, KY based, Medical Devices Manufacturing Company in partnership with University of Louisville (UofL), KY. The proposed project will see Stark supporting Research & Development for the nanotechnology based color changing biosensors in […]
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 […]
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 […]
CDSCO India: Regulatory updates on Medical device and IVDs announced
Central Drugs Standard Control Organization (CDSCO), India has rolled out several changes to its regulatory process for medical devices and in-vitro diagnostic medical devices. List of regulated medical devices- CDSCO has added ultrasound equipment to its list of medical devices falling under regulatory requirements in India. Compliance deadline of November 1, 2020 has been set for registration […]
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 […]
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 […]
FDA issues final guidance on medical devices containing animal or animal-derived materials
The US Food and Drug Administration (FDA) has issued final guidance on medical devices containing materials derived from animal sources on March 15, 2019.The guidance is intended to help medical device companies establish and document procedures that mitigate risk of infectious disease exposure through contact with devices containing animal-derived materials. In the final guidance, the recommendations for […]
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