Decree No. 342/2025/ND-CP, which took effect on 15 February 2026, updates the rules regarding the advertising of medical devices1. Importantly, Article 32 of this Decree explains that the regulations regarding the advertising of medical devices are now implemented in accordance…
The proposed rule entitled General and Plastic Surgery Devices: Restricted Sale, Distribution, and Use of Sunlamp Products, which published in the Federal Register on 22 December 2015, was withdrawn on 16 March 20261. The Food and Drug Administration received more…
United States Pharmacopeia (USP) General Chapter <665>, Plastic Components and Systems Used to Manufacture Pharmaceutical Drug Products and Biopharmaceutical Drug Substances and Products, comes into force on 1 May 20261. It deals with the chemical characterisation of plastic components and…
On 23 March 2026, the Food and Drug Administration (FDA) revoked1 the regulations entitled Mutual Recognition of Pharmaceutical Good Manufacturing Practice Reports, Medical Device Quality System Audit Reports, and Certain Medical Device Product Evaluation Reports: United States and The European…
Upon request, the Food and Drug Administration has classified the setmelanotide eligibility gene variant detection system into Class II (special controls), as the Agency has determined that special controls, in combination with general controls, should provide a reasonable assurance of…
The Food and Drug Administration (FDA) has classified the transcutaneous electrical nerve stimulator for the relief of congestion into Class II (special controls), subject to pre-market notification1. The Agency has taken this action because it has determined that classifying the…
Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions – Guidance for Industry and Food and Drug Administration Staff was published in February 20261. This final guidance document provides the Food and Drug Administration’s recommendations to…
Interested parties have until 29 May 2026 to submit comments on the proposed reclassification1 of Mycobacterium tuberculosis cell-mediated immunity tests and Mycobacterium tuberculosis cell-mediated immune response enzyme-linked immunospot tests intended for use as an aid in the diagnosis of Mycobacterium…
On 23 April 2026, the Centers for Medicare & Medicaid Services (CMS) and the Food and Drug Administration (FDA) announced the Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway1. This initiative is designed to accelerate access to certain…
When the Food and Drug Administration began implementing the Quality Management System Regulation on 2 February 2026, it discontinued use of its Quality System Inspection Technique for medical device inspections. It now conducts inspections using the process described in the…
On 19 February 2026, the US Food and Drug Administration (FDA) published another significant update to its list of recognised consensus standards entitled Modifications to the List of Recognized Standards, Recognition List Number: 0651. These standards are intended to help…
Non-invasive bone growth stimulators (product codes LOF and LPQ), which were post-amendments Class III devices, have been reclassified into Class II, subject to pre-market notification1. The reclassification of these devices has been codified under a new classification regulation, §890.5870, Non-invasive…
Optical diagnostic devices for melanoma detection (product code OYD) and electrical impedance spectrometers (product code ONV), both post-amendments Class III devices, have been reclassified into Class II (special controls), subject to pre-market notification1. The Food and Drug Administration (FDA) has…
Comments are being accepted until 18 May 2026 on a proposal to classify blood irradiator devices (product code MOT), which are currently unclassified pre-amendments devices, into two classes based on their intended use1. The Food and Drug Administration has proposed…
The digital therapy device for amblyopia has been classified into Class II (special controls), subject to pre-market notification1, and the classification has been codified at §886.5500. A digital therapy device for amblyopia is a device that incorporates dichoptic presentations on…
The Food and Drug Administration (FDA) has classified the device for sleep apnoea testing based on mandibular movement into Class II (special controls), subject to pre-market notification1 and codified the classification at §868.2376. A device for sleep apnoea testing based…
Upon request, the Food and Drug Administration (FDA) has classified1 the manual surgical instrument for appropriate patient selection for orthopaedic implant into Class II (special controls), subject to pre-market notification. The FDA has codified the classification at §888.4510. A manual…
Comments were accepted until 7 April 2026 on a list of Class II devices that have been proposed for exemption from the pre-market notification requirements, subject to certain limitations1. After considering the comments received, the Food and Drug Administration (FDA)…
Guidance entitled Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle has been finalised and published by the Food and Drug Administration (FDA)1. The guidance describes the principles and concepts that the FDA recommends sponsors and other interested…
The final guidance entitled Medical Devices with Indications Associated with Weight Loss – Premarket Considerations provides recommendations regarding non-clinical testing and clinical study design for medical devices with indications for use associated with weight loss to support pre-market submissions1. The…
In response to a de novo classification request, the Alzheimer’s disease pathology assessment test has been classified into Class II (special controls), subject to pre-market notification1. The classification has been codified at §866.5840. An Alzheimer’s disease pathology assessment test is…
On 20 February 2026, an update was issued1 to the guidance on how to register medical devices with the Medicines and Healthcare products Regulatory Agency (MHRA) for the Great Britain and Northern Ireland markets. The update included changes to the…
On 16 April 2026, a new statutory annual registration fee was added to the medical device fees section 7d1. The fee charged is £300 per Level 2 (or Level 1, where no Level 2 exists) Global Medical Device Nomenclature (GMDN®) Category.…
A consultation on proposals for indefinite recognition of CE marked medical devices in Great Britain was held from 16 February to 10 April 20261. The three proposals were as follows: Proposal 1. Extend the current transitional arrangements in Regulation…
Numerous guidance documents have been published recently by the Medicines and Healthcare products Regulatory Agency (MHRA) on various topics relating to medical device clinical investigations: Medical devices that need a clinical investigation1 – How to determine if it will…
On 2 March 2026, the President of the European Commission and the President of the Swiss Confederation signed1 a broad package of agreements to strengthen bilateral cooperation between the European Union (EU) and Switzerland, and to provide a more stable…
The ‘Legacy Devices’ feature was activated in the [unique device identification] UDI Devices module of swissdamed on 5 February 20261. This new feature allows legacy devices – devices under the old legislation according to Article 101 of the Medical Devices…
Medical devices, systems and procedure packs The registration of medical devices, systems, and procedure packs in accordance with Article 108 of the Medical Devices Ordinance (MepV) will become mandatory in swissdamed on 1 July 2026, with a transitional period until…
Version 2.1 of the Swiss Good Practice for the Maintenance of Medical Devices (GPI) has been published1. This latest update makes editorial changes and adjustments on page 19 (section 4.2.2, Maintenance by internal or external, manufacturer-independent maintenance providers) and page…
The Guidelines for Amendments and Modifications of Medical Device Products was revised on 16 March 20261 to provide updated guidance to applicants on preparing documents for submitting Change Notification applications for medical devices. The update explains which changes fall outside the scope…
A period of public consultation1 has been held on a draft Announcement of the Ministry of Public Health Regarding the Criteria, Methods, and Conditions for the Use of Medical Devices in Clinical Research Studies, B.E. designed to revise and modernise…
On 25 February 2026, the South African Health Products Regulatory Authority (SAHPRA) published a Guideline for Licence Applications for Non-ionising Radiation Medical and Non-medical Devices Classified as Listed Electronic Products (SAHPGL-RDN-NM-01)1. The selling, letting, use, application, installation, manufacture, and importation…
On 8 April 2026, the Medical Products Agency published a new version of its guidance on the use of artificial intelligence (AI) in Swedish healthcare1, updating the previous guidance from 2023. Among other things, the guidance highlights the importance of…
Guidance (SAHPGL-MD-21) has been provided on obtaining a Certificate of Free Sale (CFS), which serves as confirmation that the listed medical devices, including in vitro diagnostic medical devices (IVDs), are legally sold or distributed, without restriction, in South Africa1. The…
Version 1 of the Medical Devices Reliance Guideline, SAHPGL-MD-22, was published on 25 February 20261. This guideline outlines the principles and procedures for reliance-based review in both pre-market and post-market regulatory activities for medical devices, including in vitro diagnostics (IVDs). It defines…
Public feedback has been solicited on a draft Administrative Order designed to provide guidance on good storage and distribution practices for medical devices1. It is intended for establishments involved in manufacturing, importing, distributing, and selling medical devices, including in vitro…
Comments have been sought on draft Guidelines on the Maintenance of Importation and/or Distribution Records, and the Reporting of Product Complaints, Adverse Events, and Field Safety Corrective Actions for Medical Devices1. The purpose of these Guidelines is to establish requirements…
According to a recent Communication to Stakeholders (MD102025/26)1, licensees are required to apply for an amendment of a medical device establishment licence in the event of a change in any of the following: particulars of the licence holder; Class…
Stakeholders have been provided with clarification1 on the requirements for medical device (including in vitro diagnostic, IVD) manufacturers, distributors and wholesalers who appoint or contract a third-party to perform manufacturing, distribution or wholesaling activities on their behalf, for the purpose…
A public consultation has been held1 on proposals for new criteria for the eco-labelling of medical devices made of plastic or silicone under the Nordic Swan Ecolabel, a voluntary eco-labelling scheme for the Nordic countries (Denmark, Finland, Iceland, Norway and…
MDA/GD/0006, Definition of Medical Device, was updated in March 20261 to include definitions for the terms ‘accessory’, ‘component’ and ‘spare part’. This second edition of the guidance aims to assist industry stakeholders in correctly identifying which items require registration and…
The third edition of the medical device guidance document MDA/GD/0043, Import and/or Supply of Unregistered Medical Devices Under Special Access Exemption Application, was released in March 20261. This updated guidance outlines the regulatory framework for the importation and use of special…
The guidance document MDA/GD/0066, Importation of medical device for personal use, has been officially withdrawn. However, all information previously contained in the guidance document will continue to be made available on the MDA website for regulatory reference1. Reference 1. …
On 3 February 2026, the Medical Device Authority (MDA) became1 a participating national regulatory authority in the World Health Organization (WHO) Collaborative Registration Procedure for WHO prequalified in vitro diagnostics (IVDs). This reliance-based regulatory mechanism is designed to facilitate and…
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 revision of the Mandatory Standard SI 60601-1, dealing with the general requirements for basic safety and essential performance of medical electrical equipment, was published in Israel’s Official Gazette, Section of Government Notices, No. 12252 and entered into force on…
An updated English compilation of the Medical Device GMP [Good Manufacturing Practice] Regulations was issued in February 20261. The compilation covers four main pieces of legislation: Enforcement Rule of the Medical Devices Act (effective 31 October 2025) [Ordinance of…
The Medical Device Authority (MDA) has confirmed1 that approvals issued by the Health Sciences Authority (HSA) of Singapore will be permitted for use in conformity assessments through the verification process, following the successful completion of a six-month pilot programme. Both…
In March 2026, the Medical Device Authority (MDA) officially launched its Innovative Medical Device Review Pathway, a strategic initiative to support the development and regulatory readiness of innovative medical devices in Malaysia1. Currently, the pathway includes a sole, key initiative:…
Pursuant to Section 15 of the Medical Device Act 2012 (Act 737), it is compulsory for all tenderers (bidders) to possess a valid Establishment Licence prior to participating in any new tender or subsequent tender activities. In addition, tenderers must…
