Regulatory Updates

Apr 28, 2021

TFDA Makes Further Announcements Regarding New Medical Device Regulations and Fees

Emergo by UL has assembled this roundup of key communications dealing with a new listing process for designated Class I devices.

Apr 27, 2021

In Brief: Japan PMDA Issues Guidance on Package Insert Digitization Requirements

Japan's Pharmaceuticals and Medical Devices Agency (PMDA) published a guidance document with directions for posting digital package inserts online

Apr 21, 2021

European Commission Offers New Guidance on Medical Device Standards Development

European Commission group provides new guidance on current and future approaches to medical device standards harmonization and development.

Apr 21, 2021

In Brief: Vietnamese Ministry of Health Proposes New Decree for Medical Device Regulation

The Vietnamese Ministry of Health published a draft decree meant to consolidate and expand the country's regulatory framework for medical devices.

New US FDA guidance provides content recommendations for medical device software premarket submissions

Apr 20, 2021

US FDA Removes Some Software Functions from Medical Device Classification Regulations

The US food and drug administration adjusted the language in eight medical device classification regulations in a ruling published in the federal register.

Apr 13, 2021

TFDA Releases Details About Transition to New Taiwanese Medical Device Regulations

The Taiwan Food and Drug Administration (TFDA) has published documents explaining aspects of the transition to new medical device regulations.

Mar 29, 2021

NMPA Publishes Revised Chinese Medical Device Regulations

Emergo by UL experts have conducted an initial review and identified the new information about the regulations that medical device manufacturers and importers will need to know.

Mar 26, 2021

Brazilian Regulators Update Economic Monitoring Requirements for Some Medical Devices

Brazilian medical device regulator ANVISA has issued new regulations regarding economic monitoring of certain device types in order to boost transparency and establish reference pricing for these products.

Mar 24, 2021

Guidelines Released for Transition in Philippines to ASEAN Harmonized Requirements

The Food and Drug Administration (FDA) of the Philippines published Circular No. 2021-002, providing for further implementation of the Association of Southeast Asian Nations (ASEAN) regulatory framework for medical devices.

Mar 23, 2021

European Regulators Publish New Q&A on Custom-Made Medical Devices

Manufacturers of custom-made medical devices (CMD) have a new FAQ resource for MDR compliance from the European commission's medical device coordinating group, or MDCG. Learn more at Emergo by UL.

Mar 22, 2021

US FDA Publishes EUA Templates for COVID-19 IVD Submissions

The new and updated templates support Emergency Use Authorization (EUA) for IVDs intended for the diagnosis and/or treatment of COVID-19.

Mar 21, 2021

New Taiwanese Medical Device Regulations Set for May 2021

Taiwan Medical Devices Act will establish new regulatory framework for medical device market access. Learn more at Emergo by UL.

Mar 15, 2021

Australia Will Develop UDI System for Medical Devices Following New Regulatory Amendment

An amendment to Australia's therapeutic goods act 1989 calls for the creation of a unique device identification (UDI) system for medical devices.

Mar 10, 2021

Importers in Northern Ireland Must Comply with MDR Requirements

Medical device and IVD importers active in Northern Ireland must comply with MDR and IVDR requirements, according to updated UK MHRA guidance. Learn more at Emergo by UL.

Mar 1, 2021

Eudamed Requirements Ahead of Eudamed

Eudamed is one of the key drivers of the European Medical Devices Regulation (EU) 2017/745 (MDR) and the In-Vitro Diagnostic Medical Devices Regulations (EU) 2017/746 (IVDR).

Feb 28, 2021

UK Passes Post-Brexit Medical Device Regulatory Bill into Law

The UK Parliament passed the Medicines and Medical Devices Act 2021, providing the foundation for the country's post-Brexit regulatory system for healthcare products.

Feb 23, 2021

UK MHRA Provides Registration Requirements for IVDs Undergoing Performance Evaluation

The United Kingdom's medicines and healthcare products regulatory agency, (MHRA) updated its medical device and IVD registration guidance to include a section on IVDs undergoing performance evaluation.

Feb 16, 2021

How Legacy Medical Devices and IVDs Will be Managed in Europe’s Eudamed Database

Unique device identifier assignments and guidelines for legacy devices whose CE Marking will remain valid after MDR, IVDR come fully into force

Feb 14, 2021

Norwegian Language Requirement Will Apply Following MDR Implementation

The Norwegian medicines agency (NoMA) has confirmed that, in order to be marketed in Norway, medical devices must include labeling and instructions for use (IFUs) in the Norwegian language.

US FDA readies transition plans for COVID-19 medical device enforcement policies

Jan 25, 2021

US FDA Ramping up Permanent 510(k) Exemptions for Dozens of Medical Devices

Nearly 100 low- and moderate-risk medical devices may soon be exempt from 510(k) premarket notification requirements in the US, according to a new FDA notice.