Final guidance for investigators, industry and Institutional Review Boards (IRBs) entitled, Investigator Responsibilities – Safety Reporting for Investigational Drugs and Devices, was issued by the Food and Drug Administration in December 20251,2. The purpose of this guidance is to help…
Comments were accepted until 26 January 2026 on a proposal to reclassify certain post-amendments Class III nucleic acid-based test systems indicated for use with a corresponding approved oncology therapeutic product (product codes OWD, PJG, PQP and SFL) from Class III…
The American National Standards Institute (ANSI) and the Association for the Advancement of Medical Instrumentation (AAMI) have updated their human factors engineering standard for the medical device industry for the first time in more than 15 years1. ANSI/AAMI HE75:2025, Human…
On 6 January 2026, Clinical Decision Support Software – Guidance for Industry and Food and Drug Administration Staff was published to supersede the 2022 guidance of the same name1. This updated guidance clarifies the scope of the Food and Drug…
Guidance has been issued to provide clarity to industry and Food and Drug Administration (FDA) staff on the Center for Devices and Radiological Health’s compliance policy for low-risk products that promote a healthy lifestyle (i.e. general wellness products). This guidance…
The Food and Drug Administration (FDA) has published a final guidance entitled, Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices1,2. The purpose of this guidance is to clarify how the FDA evaluates real-world data (RWD) to determine…
The Food and Drug Administration (FDA) has issued a draft guidance1,2 to provide advice to industry and FDA staff on the expectations for Quality Management System Regulation (QMSR) requirements for pre-market submissions once the final rule amending Title 21 of…
Upon request, the Food and Drug Administration (FDA) has classified the field generator positioning device as Class I (general controls), as the Agency has determined that general controls will provide a reasonable assurance of safety and effectiveness for this device…
The electrical tongue nerve stimulator to treat motor deficits has been classified into Class II (special controls)1. This is a prescription device that consists of a non-implantable apparatus to generate electrical pulses for stimulation of the nerves in the tongue…
The Food and Drug Administration (FDA) has received a petition requesting partial exemption from the pre-market notification (510(k)) requirements for Class II radiology computer-aided detection and/or diagnosis devices and computer-aided triage and notification devices1. Specifically, the petition requests exemption from…
Interested parties have until 24 March 2026 to submit comments on the draft guidance entitled, Cuffless Non-invasive Blood Pressure Measuring Devices – Clinical Performance Testing and Evaluation1,2. This draft guidance provides recommendations for clinical performance testing and evaluation to support…
The anchored oesophageal sheath has been classified into Class II (special controls), as special controls in addition to general controls should provide a reasonable assurance of safety and effectiveness for the device type’s intended use1. The classification has been codified…
On 21 November 2025, the Ministry of Health of Ukraine adopted Order No. 17711, approving guidelines2 on the State’s healthcare technology assessment (HTA) of medical devices (ST-N МОZU 42-9.2:2025). The guidelines define the methodological features and principles (recommendations) for conducting…
Guidance from the Medicines and Healthcare products Regulatory Agency (MHRA) on how to notify the MHRA of an intention to carry out a clinical investigation for medical devices1 has been updated numerous times over the past three months. In January…
On 12 January 2026, updates were made to the guidance on submitting an application for approval of a clinical trial that includes an in vitro diagnostic device (IVD)1. This update has clarified the documentation requirements where the device is not…
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has provided guidance on its structured regulatory advice service for manufacturers and stakeholders developing medical devices and in vitro diagnostics (IVDs) in Great Britain1, which is particularly useful when the application…
A new roadmap was published on 15 December 2025 to set out deliverables and timelines to support the development of safe in vitro diagnostic (IVD) medical devices1. The roadmap outlines broad timelines and deliverables for 2026 and 2027 across three…
The registration of products, systems and treatment units will become mandatory in swissdamed from 1 July 2026, with a transition period until 31 December 20261. The product registration requirement in swissdamed will therefore come into effect in Switzerland approximately one…
The Swedish Medical Products Agency has separated medical technology from its other activity areas and created a new medical technology business area1. This will be led by a dedicated director with responsibility for developing and implementing strategies for both oversight…
The Council of Ministers has approved the text of the new Royal Decree on in vitro diagnostic medical devices (IVDs)1. This new Decree complements Regulation (EU) 2017/746, which established a new regulatory framework for IVDs with the aim of guaranteeing…
A period of public consultation has been held on the Medical Devices Reliance Guideline1 from the South African Health Products Regulatory Authority (SAHPRA). This Guideline is intended to provide information on, and outline the principles of, reliance-based review for both…
The Guideline for Users of Ultra-Portable X-Ray Equipment (SAHPGL-RDN-XR-27_v1) was first issued and implemented on 14 November 20251. The purpose of this Guideline is to assist importers, distributors, and users of ultra-portable digital x-ray (UP-XR) equipment in ensuring the safe…
Interested parties had until 14 December 2025 to submit comments on a draft Guideline for the Application of a License to Install, Use, Operate, and Apply for Magnetic Resonance Imaging (MRI) (SAHPGL-RDN-RDN-06_v1)1. The purpose of this draft document is to…
Comments have been solicited on the draft first version of SAHPGL-MD-21_v1, Guideline for Medical Device Certificate of Free Sale1. The purpose of this Guideline is to set out the process and requirements for applicants that manufacture medical devices, including in…
In the fourth version of SAHPGL-INSP-RC-08_v4, Guideline for Donation of Medicines, Medical Devices, and IVDs, updates have been made to include donation to the private sector1. The purpose of this revised document is to guide the appropriate, ethical, and effective…
A period of public consultation has been held on the Guideline for Licence Applications for Non-Ionising Radiation Medical and Non-Medical Devices Classified as Listed Electronic Products1. The purpose of this Guideline is to assist applicants in the submission of licence…
Revisions of several guidance documents were published in October 2025: GN-34: Guidance Document for IVD Analysers1 The second revision of GN-34 provides updated guidance to product owners and registrants concerning in vitro diagnostic (IVD) analysers and their associated accessories.…
Law No. 71/2025, which was published in the Official Gazette on 22 December 2025, establishes a national regime applicable to clinical research on medical devices and performance studies of in vitro diagnostic medical devices (IVDs)1, within the scope of the…
Food and Drug Administration (FDA) Circular No. 2025-007 establishes guidelines on the use of the eServices Portal System for the initial application of a Certificate of Medical Device Notification (CMDN)1. Specifically, it provides guidance on the filing of initial CMDN…
A period of public consultation has been held on draft Guidelines on the Qualification Criteria for Grouping of Medical Devices in Product Registration1. These Guidelines aim to establish a structured and transparent regulatory framework for the qualification and grouping of…
Comments have been sought on a draft Circular entitled Guidelines on the Inspection of Medical Device Establishments1. This draft Circular aims to provide guidance on the inspection of medical device establishments and the specific requirements that the Food and Drug…
Interested parties have until 6 February 2026 to submit comments on a proposed Executive Decree1 to regulate Law No. 90 of 26 December 2017 on medical devices and related products, as amended by Law No. 92 of 12 September 2019.…
Interpretive guidance1 has been published by the Federal Commission for the Protection against Sanitary Risks (COFEPRIS) for Mexican Official Standard NOM-241-SSA1-2025, Good Manufacturing Practices for Medical Devices. This guidance clarifies how manufacturers should meet Quality Management System (QMS) and Good…
All newly issued Product Classification Letters will have a validity period of up to two years from the release date of the letter, to ensure alignment with the latest regulatory requirements and facilitate better industry compliance1. If a Product Classification…
In April 2025, the new medical device ePermit System went live1 to facilitate import permit applications for medical devices and verification slip applications for non-medical devices that fall under the medical device tariff codes. Mandatory use of the ePermit System…
The Medical Device Authority published a guidance document entitled Change Management for Registered Medical Devices for public comment during December 20251. When finalised, this guidance document will replace the existing MDA/GD/0020, Change Notification for Registered Medical Device, and will be…
During December 2025, a period of public consultation was held on the second edition of the Medical Device Authority guidance document MDA/GD/0006, Definition of Medical Device1. This guidance document defines a medical device, an accessory to a medical device, components…
The Medical Device (Designated Medical Device) Order 2026 was published on 12 January 2026 and will come into effect on 1 June 20261. This Order lists the medical devices and the purposes for which they are used when classed as…
The Ministry of Health, Labour and Welfare’s Cabinet Order No. 362 of 20251–3 revises, among others, the Enforcement Order of the Act on Securing the Quality, Efficacy, and Safety of Pharmaceuticals, Medical Devices, etc. One amendment to the provisions identifies…
Comments are being accepted until 27 February 2026 on draft Review points for home-use medical devices that detect signs of illness and encourage medical consultations1. These review points (e.g. test conditions and evaluation points for evaluating safety and efficacy) apply to…
ISO/IEC TS 42119-2:2025, Artificial intelligence – Testing of AI – Part 2: Overview of testing AI systems, was first published in November 20251. This 34-page standard provides requirements and guidance on the application of the ISO/IEC/IEEE 29119 series to the…
Decree No. 221 of 2025, which sets out the procedures for implementing foreign halal certificate registration, was published on 15 September 2025 with an effective date of three months later1. Based on the provisions of Article 145 paragraph (2) of…
Updates have been published to the medical device classification lists for interventional radiology1, radiotherapy2, oncology3, and Class A (non-sterile and non-measuring) medical devices4. The existing classification lists for these categories of medical devices have been reviewed and new entries added…
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…
The Ministry of Health and Family Welfare has drafted significant changes to the Medical Devices Rules, 2017 in an effort to simplify licensing procedures, strengthen compliance, and introduce perpetual validity for licences and registration certificates1. The proposed amendments introduce streamlined…
MedTech Mitra’s In-Vitro Diagnostic [IVD] Innovators Handbook1 has been developed to support stakeholders involved in the development and evaluation of IVDs, including manufacturers, developers, regulators, healthcare providers, and academic researchers. The handbook addresses the complex requirements associated with IVD development…
On 31 December 2025, the following five guidance documents were updated with immediate effect: GN-07, Guidance on Listing Matters for Medical Device Importers1 Section 8.2.2 has been added to read: ‘8.2.2 If the existing importer list has expired, the…
At the 29th meeting of the Global Harmonization Working Party (GHWP) in Bangkok, Thailand on 4 December 2025, the following Working Group (WG) guidance documents were endorsed1 according to the simple majority rule: WG1-WG2-WG3, Guidance on Determining of Lead Authority…
A Decision dated 18 December 2025 has established the procedures for the internal and external quality control of computed tomography (CT) scanners. This decision will enter into force 18 months after its publication; operators of CT scanners must implement these…
Medical devices must bear the CE marking to be marketed within the European Union. However, in certain specific cases provided for by the Regulations, the French National Agency for Medicines and Health Products Safety (ANSM) may exceptionally grant a derogation…
