The seventh edition of MDA/GD/0026, Requirements for labelling of medical devices, has been published to include guidance for manufacturers on implementing electronic labelling for home-use medical devices1. The electronic labelling approach is permitted providing the manufacturer has conducted a risk…
The second edition of ISO 20417:2026, Medical devices – Information to be supplied by the manufacturer, was released in March 20261. ISO 20417 specifies the general requirements for information supplied by the manufacturer for medical devices and accessories, including identification,…
Comments were accepted until 16 January 2026 on a draft guidance entitled, Menstrual Products – Performance Testing and Labeling Recommendations1,2. This draft guidance document provides recommendations for performance testing, labelling, and information for inclusion in pre-market notification (510(k)) submissions, when…
The Legal Metrology (Packaged Commodities) Amendment Rules, 20251, which were published in the Official Gazette on 24 October 2025, exempt packages containing medical devices from the scope of the Legal Metrology (Packaged Commodities) Rules, 2011. Instead, such packages will now be…
Guidance on how medical devices must comply with the Essential Principles was updated in November 2025 to include information on Essential Principle 131. Essential Principle 13 of Schedule 1 to the Therapeutic Goods (Medical Devices) Regulations 2002 specifies the requirements for information…
Regulatory authority The primary authority responsible for the regulation of medical devices in Jordan is the Jordan Food and Drug Administration (JFDA), an independent public institution established in 2003. When the JFDA was first established by Provisional Law No. 31…
Swissmedic has adopted1, with immediate effect, the new European Union (EU) requirements for the electronic provision of instructions for use for medical devices as provided for by Commission Implementing Regulation (EU) 2025/1234 of 25 June 2025 amending Implementing Regulation (EU)…
The Directorate for Medical Products has submitted for consultation, on behalf of the Ministry of Health and Care Services, proposals for amendments1 to Regulation No. 1476 of 9 May 2021 on medical devices. The consultation, which runs until 17 November…
The seventh edition of the guidance document Requirements for Labelling of Medical Devices has been drafted and circulated for public comment1. This draft guidance updates and clarifies the requirements for medical device labelling, particularly the inclusion of electronic labelling requirements…
Comments are being accepted until 5 August 2025 on a draft guidance entitled, Hernia Mesh – Package Labeling Recommendations1,2. This draft guidance provides labelling recommendations for hernia mesh devices that are intended to help promote the safe and effective use…
According to paragraph 3 of Article 40.0 of Decree-Law No. 29/2024 of 5 April 2024, the labelling, instructions for use and advertising material of the device, implant card and other information to be made available by the manufacturer, namely graphical…
Commission Implementing Regulation (EU) 2025/1234 of 25 June 2025 has been published1 to amend Implementing Regulation (EU) 2021/2226 with respect to the provision of instructions for use in electronic form. The scope of Commission Implementing Regulation (EU) 2021/2226 was limited…
Introduction The National Drug Authority (NDA) has a mandate to ensure the availability, at all times, of essential, efficacious and cost-effective drugs to the entire population of Uganda, as a means of providing satisfactory healthcare and safeguarding the appropriate use…
The Medical Devices (Amendment) (Great Britain) Regulations 2025 will come into force on 24 May 2025 to provide continuity in the regulation of medical devices by maintaining the regulatory status quo1. These Regulations extend to England, Wales, Scotland and Northern Ireland, but…
A period of public consultation has been held on a draft Commission Implementing Regulation designed to amend the current rules for providing instructions for use for medical devices in electronic format1. The proposed Implementing Regulation would allow instructions for use…
The Estonian Medicines Agency has prepared an informational letter1 for foreign medical device manufacturers to explain the language requirements in Estonia and to help manufacturers better understand and comply with the requirements necessary for selling devices in Estonia. Information that…
Regulatory authority The Botswana Medicines Regulatory Authority (BoMRA) was established through the Medicines and Related Substances Act of 20131. BoMRA is responsible for regulating medical devices, including in vitro diagnostic medical devices (IVDs), to ensure compliance with strict standards for…
Regulatory authority The Saudi Food and Drug Authority (SFDA) is responsible for the administration of medical device regulation in the Kingdom of Saudi Arabia. It oversees the evaluation, classification, registration and licensing of all medical devices, as well as medicinal…
Public feedback is being sought on a draft guidance document concerning the non-clinical and clinical performance testing, labelling, and pre-market submission recommendations for pulse oximeters for medical purposes1,2. When finalised, this draft guidance document will provide recommendations regarding non-clinical and…
Final guidance has been published on communications from companies to healthcare providers regarding scientific information on unapproved uses of approved/cleared medical products1,2. This guidance describes the Food and Drug Administration’s (FDA’s) enforcement policy regarding certain company-initiated communications of scientific information…
Guidelines for the correct labelling of medical surgical devices were formalised through publication of the Decree of the Director General of 17 December 20241. These guidelines have been designed to help protect the health of the consumer and the professional…
Country Are eIFUs allowed? For which users? Additional comments Australia Yes for: a) active implantable medical devices and their accessories b) implantable medical devices and their accessories c) fixed installed medical devices d) medical devices and their accessories fitted with…
A guidance document entitled Acceptable Media for Electronic Product User Manuals, which was originally published in March 2010, has been updated to clarify that manufacturers can provide user manuals accompanying electronic products in either paper or electronic form1. This action…
Resolution (RDC) No. 924 of 19 September 20241, which was published in the Official Gazette No. 185 of 24 September 2024, establishes standardised phrases for the declaration of the presence of natural rubber latex on labels of affected medical devices,…
Regulatory authority The Ministry of Food and Drug Safety (MFDS) is responsible for medical device regulation in the Republic of Korea. It oversees the evaluation, classification, registration, and licensing of all medical devices. It is also responsible for reviewing and…
The language requirements for the information and instructions that accompany a medical device and an in vitro diagnostic medical device in a specific country, provided by the European Commission and Member States, have been updated. Revision 1 of the tables1…
Feedback is being sought until 28 May 2024 on how instructions for use (IFU) are provided, and whether electronic IFUs (eIFUs) should be made available in more flexible formats1. Specifically, the consultation wants stakeholder input on the following questions: …
Regulatory authority The Iranian Food and Drug Administration (IFDA) is an independent agency which operates under the Ministry of Health and Medical Education and oversees the evaluation, classification, registration, licensing, and importation of all medical devices. The head of the…
To help manufacturers of medical devices and in vitro diagnostics (IVDs) understand the language requirements for the information and instructions that accompany a device in a specific country, the European Commission and Member States have created tables1 that provide an…
A notification1 was issued in December 2023 regarding the additional marking of medical devices and in vitro diagnostics (IVDs) during the transition period that applies for transitioning from Directives 90/385/EEC, 93/42/EEC and 98/79/EC to Regulations (EU) 2017/745 and (EU) 2017/746.…
In November 2023, the Global Harmonization Working Party (GHWP) finalised and released the following guidance documents: GHWP/WG1-WG2-WG3/F002:2023, Principles of Regulatory Requirements for Electronic Instructions for Use (eIFU)1 GHWP/WG2/F001:2023, Guidance for Additional Considerations to Support Conformity Assessment of In vitro…
The Ministry of the Environment has changed the timetable for the implementation of producer responsibility for packaging from 1 January 2025 to 1 July 20251. The start date for reporting the quantities of packaging that companies expect to market has…
On 16 October 2023, updated guidance was issued1 to address commonly asked questions on the off-label use of medical devices. ‘Off-label use’ means using a product for a reason that is not listed as one of the indications for use…
Interested parties have until 20 November 2023 to submit comments to the Global Harmonization Working Party (GHWP) Secretariat (secretariat@ghwp.info) on the following proposed guidance documents: Guidance Document on the Risk-Based Approach to Quality Management System Aspects: ISO 13485:20161 Guidance for…
Final guidance has been published1,2 to provide labelling recommendations for hydrogen peroxide-based contact lens care products (HPCPs) submitted in pre-market notification (510(k)) submissions. These labelling recommendations are important because misuse associated with these devices has resulted in serious eye injuries.…
Regulatory authority State registration is a mandatory procedure necessary for the legal circulation of medical devices in the Republic of Serbia. The following authorities are involved in the approval and marketing of medical devices: Ministry of Health (www.zdravlje.gov.rs) is…
Consultations carried out by the National Agency for the Safety of Medicines and Health Products (ANSM) with pharmacists who distribute or use medical devices or in vitro diagnostic medical devices show that most of the Field Safety Notices (FSNs) they…
Regulatory essentials Regulatory authority Directorate of Medicines and Pharmacy (Direction du Médicament et de la Pharmacie, DMP) Classification system Medical devices: Classes I, Im (measuring), Is (sterile), IIa, IIb, III In vitro diagnostic reagents: None Registration requirements Application form, administrative…
Resolution RDC No. 777 of 1 March 20231 has made minor changes to the rules for risk classification, notification and registration, and labelling/instructions for use of medical devices as set out in Resolution RDC No. 751 of 15 September 20222.…
Overview of Mexico Mexico is a country with more than 125 million inhabitants and a wide diversity of medical conditions, most of them chronic and degenerative, such as cardiovascular disease, diabetes and cancer. To understand the Mexican market for medical…
Descripción general del país México es un país con más de 125 millones de habitantes, con una gran diversidad de padecimientos, la mayoría crónico degenerativos, como son las enfermedades cardiovasculares, diabetes, cáncer, entre otros. Para entender el mercado de los…
Introduction The entire Brazilian regulatory framework for medical devices has undergone a fundamental review to ensure a high level of health and safety, bringing more robustness, transparency, predictability and sustainability to manufacturers, importers, exporters, distributors and the market. The new…
The Department of Medical Devices has announced that the Act on Medical Devices and In Vitro Diagnostic Medical Devices (Act No. 375/2022 Coll.) has been published and took effect on 22 December 20221. This Act aligns Czech legislation with Regulation (EU)…
The updated Estonian Medical Device Act entered into force on 1 January 20231. This Act specifies, among other things, important requirements for the production, distribution and use of medical devices in Estonia. It also establishes fees and changes the previously…
On 20 January 2023, the Estonian Health Board decided that if a product (e.g. a disinfectant) meets the requirements of both the Medical Device Regulation and the Biocides Regulation, dual labelling of the product is acceptable1. Previously, these products had…
[Chart summarising the language requirements for labels and instructions for use by lay persons and professional users in the European Union.] Member State Language(s) required for lay use Language(s) required for professional use Source document Austria German German and English…
Procedures have been issued1 for evaluating modifications of registered medical devices (case studies) in terms of their instructions for use or package labels following the implementation of Regulation (EU) 2017/745 on medical devices. A flowchart of the evaluation process, including…
A period of public consultation has been held on a draft guidance entitled Hydrogen Peroxide-Based Contact Lens Care Products: Consumer Labeling Recommendations--Premarket Notification (510(k)) Submissions1,2. This draft guidance provides labelling recommendations for hydrogen peroxide-based contact lens care products (HPCPs) submitted…
Comments have been solicited on draft guidance entitled Laser-Assisted In Situ Keratomileusis (LASIK) Lasers–Patient Labeling Recommendations1–3. This guidance sets out the Food and Drug Administration’s proposed recommendations for the content and format of patient labelling for LASIK devices, including: general…
The Collegiate Board of Directors has approved the proposed Resolution1 that revises RDC No. 185/2001, the regulation that deals with the registration of medical devices in Brazil. The new text aligns with Mercosur Resolution GMC No. 25/2021, which updates the documentation…
