EU: Medical Devices Regulation – instructions for use in electronic format The EU Commission is conducting a public consultation on a new regulation allowing instructions for use in electronic format under the Medical Devices Regulation. Commission Implementing Regulation (EU) 2021/2226 as regards electronic instructions for use of medical devices currently restricts its application to specific...
Mexico: New regulation for medical devices Mexico has published a draft Mexican Official Standard PROY-NOM-137-SSA1-2024 on the labelling of medical devices. The notified draft Mexican Official Standard is mandatory throughout Mexican territory for establishments involved in the manufacture, packaging, distribution and import of medical devices to be marketed or supplied in Mexico. The notified...
EU: Longer transition period for the Medical Devices Regulation EU published a Proposal for a Regulation amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices. Regulation (EU) 2017/745 on medical devices (MD Regulation) and Regulation (EU) 2017/746 on in vitro diagnostics...
EU: New Guidance on the difference between medical devices and medicinal products The EU Medical Device Coordination Group has published a new document: A Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices. The reason for this guidance is a blurred difference between the two legal definitions:...
USA: Quality System Regulation Amendments for medical devices and harmonization with international standards The American Food and Drug Administration (FDA) has proposed to amend the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) Regulation to align more closely with the international consensus standard for medical devices. This may happen by...
Philippines: Adoption of the Post-Marketing Alert System (PMAS) Requirements for medical devices The Philippines is a signatory to ASEAN Medical Device Directive (AMDD) since 2014 and it adheres and commits to its provisions and its Annexes. The government of Philippines signed the Instrument of Ratification of the AMDD on 18 November 2020 and the...
Draft Commission Implementing Regulation laying down common specifications for the groups of products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745 (Medical Devices Regulation) on medical devices was published. Generally, the Medical Devices Regulation applies to medical devices for human use and accessories for such devices in the Union. However,...
El Salvador published a New Salvadoran Technical Regulation RTS 11.03.02:21: Medical devices. Requirements for the sanitary regulation of medical devices. The notified Regulation establishes the technical provisions governing the sanitary regulation of medical devices in El Salvador, on the basis of the existing legal framework and the internationally harmonized principles of good regulatory practice. The...
Draft Commission Implementing Regulation laying down common specifications for the groups of products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745 (Medical Devices Regulation) on medical devices was published. Generally, the Medical Devices Regulation applies to medical devices for human use and accessories for such devices in the Union. However,...
Mexico published technical regulations pertaining to Mexican Official Standard NOM-241-SSA1-2018: Good manufacturing practices for medical devices. The purpose of this Standard is to establish the minimum requirements for the design, development, manufacturing, storage and distribution processes of medical devices, based on their level of risk; in order to ensure that they consistently meet the requirements...
The content provided on this website is not intended to and does not constitute legal advice. Submissions or postings to the website are not confidential. We do not warrant or guarantee the accuracy, completeness or adequacy of the content. Your use of the content on the website or materials linked from this website is at your own risk.
Copyright © Product Compliance Institute 2025
English 
Deutsch 
Français 
Italiano 
Español 
Polski 
Português do Brasil