On 5 March 2025, Regulation (EU) 2025/327 on the European Health Data Space (EHDS) was officially published in the Official Journal of the European Union1 and entered into force later that month, marking the beginning of the transition period. The…
In February 2025, the European Medicines Agency (EMA), in collaboration with the European Commission, formally established a standard procedure for manufacturers of certain high-risk medical devices to request scientific advice on their intended clinical development strategy and proposals for clinical…
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…
Commission Implementing Decision (EU) 2025/681 of 8 April 20251 amends the Annex to Implementing Decision (EU) 2021/1182, which lists the references of harmonised standards drafted in support of Regulation (EU) 2017/745 (MDR). Commission Implementing Decision (EU) 2025/681 adds the following…
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…
The Central Administration for Medical Supplies has announced1 the activation of a link that allows local medical supply manufacturers to upload the required documents (specified in the link) for review by the relevant department. This link is for use by…
The Egyptian Guideline for Medical Device Vigilance System 2025 has been the subject of a recent public consultation1. This document sets out the objectives and processes of Egypt’s medical device post-market surveillance and vigilance system, as conducted by manufacturers with…
The new price list for services in the field of medicines and medical products performed by the Agency for Medicinal Products and Medical Devices of Croatia (HALMED) entered into force on 1 April 20251. The new fees apply to all…
Feedback has been sought on measures to optimise the supervision of the entire lifecycle and support the innovative development of high-end medical devices1. The term ‘high-end medical devices’ refers to products such as medical robots, high-end medical imaging equipment, artificial…
Table CN1 lists 10 new medical device industry standards that have been published and their dates of implementation1. [Table CN1. New medical device industry standards] Standard number and name Status Implementation date YY 0267-2025, Blood Purification Extracorporeal Circulation System…
The National Medical Products Administration has decided to abolish the following medical device industry standards: YY 0605.12-2016, Surgical implants – Metallic Materials – Part 12: Wrought cobalt-chromium-molybdenum alloys (date of repeal: 1 November 2026)1; YY/T 1294.2-2015, Surgical implants –…
In order to standardise and improve the quality of inspections of medical device clinical trials, the National Medical Products Administration has revised its Key Points and Judgment Principles for Inspection of Medical Device Clinical Trial Projects1. The drug regulatory authorities…
The Center for Medical Device Evaluation has developed the following two Implementation Rules1: Implementation Rules for the Special Review Application for Innovative Medical Devices by the Medical Device Technology Review Center, covering: Chapter I: General Provisions Chapter II: Innovation…
The following Guiding Principles have been published by the Center for Medical Device Evaluation1: Guiding Principles for Clinical Evaluation and Registration Review of Extracorporeal Membrane Oxygenation Systems (22 April 2025); Guiding Principles for the Registration Review of Type I…
Announcement No. 3 of 2025, dated 27 March 2025, details further support available for innovative medical device products in China1. For innovative medical device products, after the applicant completes the pre-clinical research and development of the product and the feasibility…
The following draft Guiding Principles have been issued by the Center for Medical Device Evaluation for the purpose of seeking feedback from interested stakeholders1: Guiding Principles for the Registration Review of Laparoendoscopic Surgery Systems – Part 4: Risk Management…
Comments are being sought on two draft standards concerning contact lenses: National Standard of the People’s Republic of China, Ophthalmic optics – Contact lenses – Part 2: Rigid contact lenses, which specifies the requirements, test methods, labelling, marking and…
Interested parties have until 7 May 2025 to submit feedback on a draft revision of the Medical Device Classification Rules1. These rules are used to guide the formulation and adjustment of the classification guidelines and the classification catalogues of medical…
Announcement No. 30 of 2025 has been published to amend and optimise matters relating to the manufacture of imported medical devices1. The foreign-invested companies referred to in the Announcement may be companies established by the registrant of imported medical devices,…
Between 20 February 2025 and 21 April 2025, Health Canada sought feedback on the updated Guidance on the Management of Applications for Medical Device Licences1. This document explains to medical device manufacturers how medical device licence applications submitted under the…
Pre-market guidance for machine learning-enabled medical devices (MLMD)1, published in February 2025, outlines supporting information to consider when manufacturers are demonstrating the safety and effectiveness of an MLMD for the purposes of applying for or amending a Class II, III or…
Interested parties – including manufacturers, importers and distributors of all classes of medical devices included in a co-packaged drug product – have until 18 May 2025 to submit comments on a draft guidance that explains the regulatory requirements for co-packaged…
In order to adapt to the new regulations for in vitro diagnostic medical devices (IVDs), the notifications of products previously regulated under the technical name ‘solution for cleaning equipment’ are being cancelled1. ‘Solution for cleaning equipment’ means laboratory products used…
The rule on the health classification of ultrasensitive C-reactive protein (CRP) tests has been revised and, as a result, the classification of these devices has been changed from risk Class III to risk Class II1. The classification rules that regulate…
Comments are being accepted until 26 May 2025 on a draft Normative Instruction that establishes the requirements for the transmission of data to, and management of, the database on the Unique Device Identification (UDI) of medical devices1, as established by…
Circular No. (5) for the Year 20251, dated 24 March 2025, specifies certain amendments to Resolution No. (69) of 2024, which amends certain provisions of Resolution No. (48) of 2020 concerning the quality control of medical devices and products. The…
Consultation has been held on proposed amendments to the Therapeutic Goods Administration’s (TGA’s) fees and charges for the 2025–2026 financial year1. The proposal applies the 3.2% indexation factor to all fees and charges in 2025–2026. However, in applying the indexation…
Interested parties have until 23 May 2025 to submit comments on proposed changes to the classifications and definitions for in vitro diagnostic medical devices (IVDs)1. The consultation aims to confirm views on aligning Australia’s classification rules, principles, and definitions with…
As of 5 March 2025, the Uniform Recall Procedure for Therapeutic Goods (URPTG) has been replaced by the new Procedure for Recalls, Product Alerts and Product Corrections (PRAC)1. While the PRAC is a complete re-write of the URPTG to improve…
Guidance was published on 6 March 20251 to clarify the new regulatory requirements for medical devices containing medicinal, microbial, recombinant, or animal origin substances that came into effect on 1 July 2024. The new guidance helps sponsors interpret the new…
Sponsors and manufacturers have been provided with new guidance1 to help them understand their regulatory obligations under the Australian Unique Device Identification (UDI) system for medical devices and in vitro diagnostics. The guidance outlines the requirements for obtaining and applying…
In February 2025, the Therapeutic Goods Administration (TGA) published the outcome1 from a public consultation paper entitled, Proposed clarification of how Clinical Decision Support System (CDSS) software is regulated. This consultation sought feedback on the appropriateness of the current exemption…
In February 2025, the Therapeutic Goods Administration (TGA) published the outcome1 from a public consultation paper entitled, Clarifying and strengthening the regulation of Artificial Intelligence (AI). This consultation aimed to identify areas for improvement in the legislative framework to mitigate…
Since publication of ANMAT Provision No. 2565/25, imported medical products and their accessories may not enter Argentina if their expiration date is less than six months1. However, medical products and their accessories included in Article 1 and with a useful…
New final guidance has been published by the Food and Drug Administration (FDA) entitled, Transitional Enforcement Policy for Ethylene Oxide Sterilization Facility Changes for Class III Devices1,2. This guidance forms part of the FDA’s efforts to help maintain patient access…
A draft guidance for industry entitled Study of Sex Differences in the Clinical Evaluation of Medical Products has been released for public comment1,2. Clinical trials and non-interventional studies of medical products should be designed to enrol sufficient numbers of females…
On 21 November 2024, the Center for Devices and Radiological Health launched a communications pilot to enhance the medical device recall programme1. This pilot is intended to improve the timeliness of communications about corrective actions being taken by companies that…
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…
On 13 January 2025, minor updates were made to guidance entitled Premarket Approval Application [PMA] and Humanitarian Device Exemption [HDE] Modular Review to include existing processes for modular HDE submissions and other minor clarifications1. This guidance supersedes guidance previously issued…
Global Unique Device Identification Database (GUDID) – Guidance for Industry and Food and Drug Administration [FDA] Staff was issued on 17 December 20241, superseding guidance of the same name from June 2014. This guidance update reflects upcoming changes to the…
Final guidance has been published on Notifying FDA [Food and Drug Administration] of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act [Federal Food, Drug and Cosmetic Act]1,2. This guidance finalises a…
The Food and Drug Administration (FDA) has published for comment the draft guidance entitled Artificial Intelligence Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations1,2. This draft guidance proposes recommendations tailored to a total product lifecycle (TPLC) approach for…
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…
Guidance has been finalised on marketing submission recommendations for a Predetermined Change Control Plan (PCCP) for artificial intelligence (AI)-enabled device software functions1,2. This guidance provides recommendations on the information to include in a PCCP in a marketing submission for a…
Interested parties have until 10 March 2025 to submit comments on the draft guidance entitled, Validation of Certain In Vitro Diagnostic Devices for Emerging Pathogens During a Section 564 Declared Emergency, to ensure that the Agency considers those comments before…
Final guidance entitled, 510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review1,2, which supersedes the previous 510(k) Third Party Review Program guidance, clarifies how the Food and Drug Administration (FDA) will use third party review organisations…
Final guidance has been published1,2 setting out recommendations for pre-market notification (510(k)) submissions for orthopaedic, non-spinal bone plates, screws, and washers. The scope of this guidance is limited to Class II, orthopaedic, non-resorbable, non-spinal bone plate and screw systems, standalone…
Comments are being accepted until 7 April 2025 on a draft guidance entitled, Evaluation of Sex-Specific and Gender-Specific Data in Medical Device Clinical Studies, which provides guidance on the study and evaluation of sex- and/or gender-specific data in clinical investigations…
Data Normalization Challenges and Mitigations in Software Bill of Materials (SBOM) Processing – A White Paper for Medical Device Manufacturers has been prepared by The MITRE Corporation on behalf of the Food and Drug Administration1. SBOMs have emerged as key…
Guidance has been drafted on protocol deviations for clinical investigations of drugs, biological products, and medical devices1,2. Protocols document the study design, objectives, population, planned procedures, investigational product management, method(s) of data capture, monitoring and oversight plans, and statistical analysis…
