US FDA outlines next steps following COVID-19 PREPP
The US FDA have made an announcement followed by issuing a summary report on findings of a third-party review of the agency’s pandemic response efforts, the PREPP which was undertaken from July to December 2020. Based on the summary report findings as well as current FDA priorities and responsibilities, the agency will initially focus on five PREPP-related efforts. The […]
Ministry of Health and Family Welfare, India propose use of American Standard Test Methods for medical device conformance
India’s Ministry of Health and Family Welfare has proposed recognizing American Standard Test Methods (ASTM) as acceptable tools for demonstrating conformance of medical devices to safety and conformance requirements and obtaining market access in the country. The notification would amend India’s Medical Device Rules, 2017 to allow medical device market applicants to use ASTM methods to demonstrate […]
Australia’s Therapeutic Goods Administration carves out exemptions for some software-based medical devices
TGA has published the Therapeutic Goods (Excluded Goods) Amendment (Software-Based Products) Determination 2021, which will become effective on February 25, 2021. This amends the Therapeutic Goods (Excluded Goods) Determination 2018 to identify software-based devices, including software as a medical device (SaMD), that are excluded from the TGA’s medical device regulatory framework and should not be included in the […]
CFDA announces classification adjustments and UDI submission guidelines
CFDA have announced two important medical devices regulatory, first about the classification changes, and the second regarding the submission of unique device identifier (UDI) data. Adjustments in classification catalog NMPA has partially revised the Medical Device Classification Catalog, as discussed in Announcement No. 147 of 2020 (link in Chinese). Considerable changes include down-classification of 15 device types […]
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 […]
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 […]
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 […]
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