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Regulatory Updates

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Get the latest global medical device regulatory news from our experts.

New Brazil INMETRO ordinance eases inspection and documentation requirements
  • Regulatory Update
Feb 2, 2023

Brazil’s New RDC 751/2022 Incorporates European MDR Risk Classification Rules

Brazilian regulators align medical device classification rules to those of EU MDR
European Union
  • Regulatory Update
Feb 1, 2023

European Commission Proposal for Amending MDR, IVDR Makes Progress

The European Council has published a proposal for amending (EU) 2017/745 and (EU) 2017/746.
US FDA medical device user fees see modest increase for 2022
  • Regulatory Update
Jan 31, 2023

US FDA and Health Canada Launch eSTAR Pilot

The US FDA and Health Canada have announced the launch of their joint eSTAR pilot program, an interactive medical device submission form.
Additional data entry modules now online for European medical device, IVD registrants
  • Regulatory Update
Jan 30, 2023

European Commission Reports on Clinical Evaluation Consultation Procedure for Medical Devices

First EC annual report published on medical devices subject to MDR CECP requirements
US FDA formally proposes aligning Quality System Regulations with ISO 13485
  • Regulatory Update
Jan 25, 2023

US FDA Issues Final Rule to Streamline Radiological Health Regulations

The US FDA issued a final rule to streamline the radiological health regulations and clarify certain provisions.
View of London
  • Regulatory Update
Jan 24, 2023

UK MHRA Updates Roadmap for New Medical Device Regulations

UK regulators cover near-term plans to roll out new medical device market requirements
Canada Skyline.
  • Regulatory Update
Jan 19, 2023

Canada Update: Proposed Amendments to Regulations on Licensing Drugs and Medical Devices

Health Canada is proposing amendments to regulations on licensing drugs and medical devices. Also, Health Canada published its annual adjustment of fees for the fiscal year 2023-2024.
Illustration of a checklist.
  • Regulatory Update
Jan 17, 2023

European Regulators Clarify Standard Fees for MDR, IVDR

The European Medical Device Coordination Group (MDCG) has issued new guidance on standard fees for the MDR and IVDR.
New Saudi medical device regulation
  • Regulatory Update
Jan 17, 2023

KSA Update: New Guidance on Saudi Medical Device Classification and More

The Kingdom of Saudi Arabia (KSA) has introduced new guidance on medical device classification as well as other updates including guidelines for the use of radiation-emitting medical devices.
Japan city mountain
  • Regulatory Update
Jan 10, 2023

Japan Update: Notifications on Used Medical Device Sales; Simplification of Procedures for Online Applications; and More

Japanese regulators issued regulations on used medical device sales; simplification of online applications procedure, and more.
China Update: IVD classification rules, medical device self-testing requirements
  • Regulatory Update
Jan 6, 2023

China Update: Announcement No. 124 of 2022; Draft Guidelines for the Registration of Implantable Medical Devices

Chinese regulators issue regulations for enterprises’ management of medical device safety, plus draft guidelines for the registration and review of implantable medical device batteries
20th Notified Body designated under EU MDR while IVDR designations lag
  • Regulatory Update
Jan 6, 2023

What's in Store for the EU Medical Device and IVD Sectors in 2023?

Key issues regarding European MDR and IVDR compliance and implementation heading into 2023
European Union
  • Regulatory Update
Jan 3, 2023

EC Names Eighth Notified Body for IVDR

The European Commission (EC) has named QMD Services GmbH as the eighth Notified Body designated to the In Vitro Diagnostic Regulation (IVDR).
US FDA medical device user fees see modest increase for 2022
  • Regulatory Update
Dec 16, 2022

Applying the US FDA's New Human Factors Engineering Guidance for Medical Device Submissions

Our Human Factors Research & Design team takes a closer look at new FDA HFE guidance for medical devices
European Union
  • Regulatory Update
Dec 15, 2022

IVDR Update: European MDCG Issues Guidance on Substantial Modification of a Performance Study

An MDCG guidance document explains the process for obtaining permission to conduct a substantial modification of a performance study in European Union member states according to Regulation (EU) 2017/746.
European Union
  • Regulatory Update
Dec 13, 2022

European MDCG Clarifies Market Access Requirements for Legacy Devices Under Article 97 MDR

An MDCG position paper explains the process for obtaining permission to sell legacy devices in European Union member states according to Article 97(1) MDR
20th Notified Body designated under EU MDR while IVDR designations lag
  • Regulatory Update
Dec 8, 2022

European Commission Proposes Extending MDR, IVDR Transition Periods

European regulators have put forth amendments to MDR, IVDR compliance timelines to avoid medical device and IVD supply disruptions
Japan PMD Act revisions include fast-track reviews for some medical devices and IVDs
  • Regulatory Update
Dec 8, 2022

Japan’s MHLW Updates Medical Device Program Display Code and Labeling Laws

Japanese medical device regulators have updated program codes and labeling rules.
FDA Logo
  • Regulatory Update
Dec 8, 2022

New US FDA Guidance on Human Factors Engineering for Medical Devices

US regulators lay out recommendations for HFE information to include in medical device registration applications
US FDA formally proposes aligning Quality System Regulations with ISO 13485
  • Regulatory Update
Dec 6, 2022

FDA Asks COVID Test Makers to Switch from Emergency to Premarket Approvals

The US FDA has announced that manufacturers of new COVID-19 tests should now follow traditional premarket pathways.