The Order of 24 February 2026 established the list of medical devices for individual use that may be restored to good working order pursuant to Article L. 5212-1-1 of the Public Health Code1. The medical devices for individual use that…
Provision 224/2026 from the National Administration of Drugs, Food and Medical Devices (ANMAT) has amended the procedure governing the importation of used and refurbished medical devices1. The new regulations, which replace ANMAT Provision 806/2007, align the health regulations with the…
The Egyptian Drug Authority has announced the issuance of import approvals for refurbished spare parts for medical and laboratory equipment that are not classified as standalone devices1. Companies that import refurbished spare parts for medical and laboratory equipment that are…
Introduction This article provides a comprehensive overview of recent regulatory developments in South Africa pertaining to medical devices and in vitro diagnostics (IVDs), as announced by the South African Health Products Regulatory Authority (SAHPRA). One key update involves the phased…
On 16 June 2025, the cantons and Swissmedic distributed the ‘GPA-ambulant’ – an updated version of KIGAP 1.0, Good Practice for the Reprocessing of Medical Devices in Medical and Dental Practices and Other Users of Small Steam Sterilisers – to interested…
Final guidance entitled Remanufacturing of Medical Devices has been published by the Food and Drug Administration to help clarify whether activities performed on devices are likely ‘remanufacturing’ as opposed to ‘servicing’1,2. The guidance also clarifies existing regulatory requirements for remanufacturers…
Additional guidelines have been issued for business operators on remanufactured single-use medical devices1. These new guidelines include guidance on the concept of post-marketing safety measures for marketing authorisation holders of remanufactured single-use medical devices, plus two related questions and answers.…
The first edition of MDA/GL/10, Guidelines for Implementation of Medical Device Regulatory System – How to Submit an Application for Registration of a Refurbished Medical Device, was published in January 20231. This guidance has been developed to assist manufacturers and…
Notification No. 1213-1 of 13 December 2022 contains a form template for informing the Marketing Authorisation Holder of the sale, gift, lease or loan of its used medical equipment1. Manufacturers and distributors must handle such notifications in accordance with the…
New Guidelines for Medical Devices Refurbishment1 provide advice to industry on refurbishment procedures and the safety and performance requirements of refurbished medical devices intended to be used in the Ethiopian market. Reprocessing of single-use devices and the remanufacture of used…
In July 2022, the Ethiopian Food and Drug Authority posted the first edition of its Guideline for Decommissioning and Disposal of Medical Devices1. This Guideline is intended to establish a control system to ensure that medical devices destined for decommissioning…
The Medical Device Authority’s policy for the control of medical device refurbishment activities contained in Circular Letter No. 1 of 2016 (Revision 2) has been updated through the issuance of Circular Letter No. 3 of 2022, which took effect on…
New guidance has been published on the requirements that apply to refurbished medical devices placed in the Malaysian market (MDA/GD/0060)1. For unregistered medical devices, where refurbishment is conducted by the manufacturer, the manufacturer or Authorised Representative must register the medical…
Following the introduction of Regulation (EU) 2017/745 on medical devices, the reprocessing of disposable medical equipment in Norway has been prohibited since 1 January 20221. Previously, the reprocessing of disposable medical equipment had been permitted in Norway as a transitional…
On 1 January 2022, Swissmedic released a completely revised Swiss good practice for the reprocessing of medical devices – For healthcare facilities that process medical devices (GPA)1 to replace the version from 2016. This document should be regarded as a…
Resolution RDC No. 579 of 25 November 2021 defines the requirements for the importation, commercialisation and donation of used or refurbished medical devices intended for use in Brazil1. This Resolution applies to products regulated by Resolution RDC No. 185/2001 and…
Article 17 of Regulation (EU) 2017/745 on medical devices (MDR) includes specific provisions allowing for the reprocessing of single-use devices but only when permitted by Member States at a national level. Ireland’s position is set out in Statutory Instrument 261…
On 18 June 2021, a draft guidance for industry and Food and Drug Administration (FDA) staff was released concerning the remanufacturing of medical devices1,2. There is currently a lack of clarity regarding the distinction between ‘servicing’ and ‘remanufacturing’ of a…
A public consultation has been held on a proposal to establish new technical requirements for the importation, commercialisation, and donation of used, reprocessed medical devices1. Resolution RDC No. 25/2001, which currently sets out requirements for the importation, marketing and donation…
Introduction The successful functioning of healthcare systems around the world is largely dependent on the ability to provide quality, safe, cost efficient, and effective medical services to patients. The ever-increasing pressures to reduce ‘healthcare costs, reduce estimated time to repair…of…
Introduction Ophthalmic device use has seen an increase recently due to emerging technology in the areas of retinal and fundus imaging. There are different types of devices that are used to diagnose or treat eye-related disorders and most of them…
Commission Implementing Regulation (EU) 2020/1207 of 19 August 20201 sets out the Common Specifications (CSs) for the reprocessing of single-use devices as part of the application of Regulation (EU) 2017/745 on medical devices. Commission Implementing Regulation (EU) 2020/1207 has entered…
On 25 August 2020, changes were introduced to the definition of a medical device and other related definitions in the Therapeutic Goods Act 1989 and the Therapeutic Goods (Medical Devices) Regulations 2002. These changes did not, however, include the proposed…
Malaysia has updated its policy on the implementation and enforcement of rules relating to the refurbishment of medical devices1. The revised policy, which was agreed at the Medical Device Authority Meeting No. 2/2020, re-confirms that all types of refurbishment activities…
Introduction According to Title 21 of the Code of Federal Regulations (21 CFR) §801.5, reprocessing instructions are considered part of a device’s instructions for use1. This regulation supports the language of the law in section 502(f) of the Federal Food,…
In June 2020, the Health Sciences Authority (HSA) released guidance on medical devices used for the decontamination of single-use respirators during the COVID-19 pandemic1. Although respirators are generally intended for single use as their manufacturers have not validated and developed…
A period of public consultation has been held on draft guidance designed to specify the requirements for notification of refurbished medical devices to the Medical Device Authority (MDA)1. According to the guidance, a refurbished medical device is: ‘a medical…
IEC 63077:2019, Good refurbishment practices for medical imaging equipment, was published on 13 November 20191. IEC 63077:2019 describes and defines the process of refurbishing used medical imaging equipment without changing the finished medical imaging equipment’s performance, safety specifications, or intended use…
A draft Commission Implementing Regulation setting out the rules for the application of Regulation (EU) 2017/745 with respect to the Common Specifications for the reprocessing of single-use medical devices has been released1. During the consultation period, which ended on 20…
The National Health Surveillance Agency (ANVISA) has extended1 a provisional measure adopted in 2018 to permit the reuse of devices used in cardiac procedures while new rules on the subject are undergoing public consultation (see previous article). This extension, which…
In an effort to ensure that servicing activities are clearly distinguished from remanufacturing, and that all stakeholders understand the differences, the National Electrical Manufacturers Association (NEMA) has published NEMA/MITA RMD P1-2019, Considerations for Remanufacturing of Medical Imaging Devices1. This document…
The reprocessing of single-use medical devices (SUDs) takes place worldwide, including, to varying levels, within European hospitals. Manufacturers, hospitals and commercial companies have historically been subject to different regulatory requirements but this will all change with the adoption of the…
Comments were accepted until 15 July 2017 on proposed minimum quality, safety and efficacy requirements for reprocessed single-use medical devices (SUDs)1. In Japan, reprocessing is defined as the process of collecting, disassembling, cleaning and reassembling used SUDs to re-distribute as…
From 8 August 2017, manufacturers of certain reusable medical devices will have to include validated instructions for use and validation data regarding cleaning, disinfection and sterilisation in their pre-market notifications (510(k)s) to support their substantial equivalence determinations1. A list of…
Brazil is a large country with extensive and constantly expanding medical device regulations. This report explores the changes that are likely to have the greatest impact on companies’ regulatory strategies during 2018. Firstly, it sets out the official regulatory agenda…
