Regulatory Updates

Oct 18, 2021

US FDA Roundup: Final De Novo Rule, GUDID for Class I Medical Devices, Reclassification of Surgical Staples

US regulators have issued final rules for de novo novel device classification requests and up-classification of surgical staplers, as well as updated GUDID submission requirements for some class I devices. Learn more at Emergo by UL.

Phased implementation timeframes for European IVDR compliance

Oct 14, 2021

European IVDR Application Partially Postponed

European Commission proposes staggered IVDR compliance timelines to address various implementation challenges.

Oct 11, 2021

Eudamed Update: Additional Data Entry Modules Now Online for European Medical Device, IVD Registrants

European Commissioners have launched additional modules for the Eudamed medical device and in vitro diagnostic (IVD) product database developed to improve European market transparency.

Oct 11, 2021

Japanese Regulators Extend Medical Device Single Audit Program (MDSAP) Pilot

Updated Japan MHLW requirements for MDSAP report submissions take effect in April 2022

Oct 1, 2021

China Update: Clinical Evaluation Authority, Plus Guidelines for Animal Testing Studies

Chinese regulators plan new unit for clinical evaluation efforts, as well as revise animal testing study guidelines for medical device registrants. Learn more at Emergo by UL.

A person with a pen holding a checklist.

Sep 24, 2021

Learning Management System (LMS) Reporting: Formatting for Regulatory Audits

What to look for in life sciences LMS reporting features to meet requirements of FDA and other regulatory auditors and inspectors. Learn more about LMS technologies at ComplianceWire.

Sep 24, 2021

US FDA Rolls Out List of Registered Medical Devices Featuring Artificial Intelligence and Machine Learning

FDA regulators have published a searchable list of medical devices incorporating artificial intelligence and machine learning (AI/ML) to promote transparency. Learn more about US FDA regulations at Emergo by UL.

Sep 20, 2021

Australia TGA to Accept CE Mark Conformity Assessments for Some High-Risk Medical Devices, IVDs

The therapeutic goods administration (TGA) will accept conformity assessments from European notified bodies for some Class III medical devices, active implantable devices and Class 4 IVDs submitted for registration in Australia. Learn more at Emergo by UL

UK MHRA seeks public comment on 2023 medical device, IVD regulatory updates

Sep 19, 2021

UK Regulators Issue New Consultation on Updated Medical Device Regulations Slated for July 2023

UK MHRA seeks public comment on 2023 medical device, IVD regulatory updates

Sep 13, 2021

IVDR Watch: IVD Expert Panel Now Accepting Submissions for Performance Evaluation Consultations

The European Commission's Expert Panel for IVDs is now accepting submissions from Notified Bodies for consultations on performance evaluations for high-risk IVD devices.

Aug 30, 2021

Singapore HSA Finalizes Unique Device Identification (UDI) Requirements for Medical Devices

Singapore's health sciences authority (HSA) has issued final guidance on unique device identification (UDI) rules for medical devices and IVDs, with a phased implementation timeline for compliance. Learn more at Emergo by UL.

Aug 26, 2021

Chinese Regulators Revise Drug-Device Combination Product Registration Requirements

Chinese regulators have updated marketing application requirements for makers of combination products featuring pharmaceutical and medical device components. Learn more about NMPA regulations for combination products, medical devices and IVDs.

UKCA certification deadlines pushed back, but not for medical devices (so far)

Aug 25, 2021

UKCA Marking Delay: What it Means for Medical Device and IVD Manufacturers

UKCA certification deadlines pushed back, but not for medical devices (so far)

Aug 17, 2021

EU Regulatory Roundup: Combination Products, Eudamed, COVID-19 IVDs

Latest guidelines from European Medicines Agency (EMA) and EC Medical Device Coordination Group (MDCG) on CIV-ID generation for clinical studies, COVID-19 IVD performance evaluations and more.

Aug 10, 2021

US FDA Medical Device User Fees See Modest Increase for 2022

FDA has set a 2.5% increase for medical device user fees for its 2022 fiscal year. Learn more about US medical device and IVD regulations at Emergo by UL.

Aug 4, 2021

Proposed US FDA Program Targets Medical Device Supply Chain Shortages

A new program proposed by the US Food and Drug Administration would bolster domestic supply chains for medical devices during public health emergencies, but would also entail additional compliance work for manufacturers.

Aug 4, 2021

South Korea MFDS Plans Several Medical Device Regulatory Updates for 2022

The Ministry of Food and Drug Safety (MFDS), South Korea’s medical device market regulator, plans to roll out several amendments to the country’s Medical Devices Act over the course of 2022, and has also expanded its list of devices eligible for electronic

Brazil ANVISA provides new details on proposed UDI framework for medical devices

Aug 2, 2021

Brazil’s New UDI Requirements for Medical Devices: Compliance Implications for Manufacturers

Brazil ANVISA provides new details on proposed UDI framework for medical devices

Jul 31, 2021

New Guidelines Published on Integrating UDI Into Quality Management Systems Under MDR, IVDR in Europe

The European Medical Device Coordination Group (MDCG) has published new recommendations for medical device manufacturers on integrating Unique Device Identification (UDI) data into their quality management systems

UK MHRA foretells brave new world of medical product oversight with new Delivery Plan

Jul 28, 2021

Post-Brexit Medical Device and IVD Oversight: A New Plan for the UK MHRA

UK MHRA foretells brave new world of medical product oversight with new Delivery Plan