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…
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…
ISO 14155:2026, Clinical investigation of medical devices for human subjects – Good clinical practice (Edition 4) was published in March 20261. This standard specifies Good Clinical Practice (GCP) for the design, conduct, recording and reporting of clinical investigations carried out…
A Working Draft of ISO/AWI 8250, Cleanliness of medical devices – Process design and test methods, has been approved for registration as a Committee Draft1. This draft standard deals with the cleanliness of medical devices immediately after production (i.e. before…
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,…
Technical Reference document TR-010, Combination Products, was published on 1 April 2026 and became effective immediately1. This document aims to describe different categories of combination products and their examples. It also provides a reference regarding whether combination products meet the…
Commission Implementing Decision (EU) 2026/193 of 28 January 20261 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) 2026/193 adds the following…
The recently published EN IEC 60601-2-57:2026, Medical electrical equipment – Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring, cosmetic and aesthetic use, specifies essential safety and performance…
On 13 March 2026, the following two medical device industry standards were repealed1: YY/T 0605.8-2007, Surgical Implants – Metallic Materials – Part 8: Forged Cobalt-Nickel-Chromium-Molybdenum-Tungsten-Iron Alloys; YY/T 0728-2009, Surgical Implants – Use of the Terms ‘Eversion’ and ‘Inversion’ in…
The following Guiding Principles1 have been issued by the National Medical Products Administration’s Center for Medical Device Evaluation: Guiding Principles for the Registration Review of Intravascular Ultrasound Diagnostic Equipment (13 April 2026); Guiding Principles for the Registration Review of…
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…
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…
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…
Introduction In 2022, the Journal of Medical Device Regulation published an article1 by this author describing the prospects for the evolution of ISO 10993-1, with particular attention to the progressive alignment with the ISO 14971 risk management system and the…
The Egyptian Standard ES 5526-3, Transfusion Equipment for Medical Use – Part 3: Blood-Taking Sets for Single Use, was adopted on 22 October 2025 and will enter into force the day after its date of publication in the Official Gazette.…
After soliciting public opinions and organising expert reviews, the National Medical Products Administration (NMPA) has determined two recommended medical device industry standard development plans and published them for public comment1. The project plans apply to the following recommended industry standards:…
Interested parties had until 10 January 2026 to submit comments on the draft National Standard of the People’s Republic of China GB 12260-20XX, Cardiopulmonary bypass systems – Roller blood pumps1. When finalised, this standard will replace GB 12260-2017. The revised…
New and revised medical device industry standards listed in Table CN3 have been recently approved and published1. The standard number, name, status and implementation date are detailed in the table. Table CN3. New and revised medical device industry standards…
The following Guiding Principles have been released by the National Medical Products Administration1 and the Center for Medical Device Evaluation2. Final documents: Guiding Principles for the Registration Review of Human Leukocyte Antigen (HLA) Genotyping Test Reagents (9 January 2026);…
The fourth edition of ISO 7405:2025, Dentistry – Evaluation of biocompatibility of medical devices used in dentistry, has been issued1. ISO 7405 provides a set of biological test methods to evaluate the biocompatibility of medical devices used in dentistry. These…
Commission Implementing Decision (EU) 2025/20781 amends the Annex to Implementing Decision (EU) 2021/1182 with respect to harmonised standards for surgical clothing and drapes, medical face masks and sterilisers for medical purposes. Implementing Decision (EU) 2021/1182 lists the references of harmonised…
Comments are being accepted until 4 November 2025 on the following draft standards: National Standard of the People’s Republic of China, Implants for surgery – Metallic materials – Part 1: Wrought stainless steel1 This document specifies the performance requirements and…
New and revised medical device industry standards listed in Table CN1a have been recently approved and published1. The standard number, name, status and implementation date are detailed in the table. Table CN1a. New and revised medical device industry…
The following Guiding Principles have been released by the National Medical Products Administration1 and the Center for Medical Device Evaluation2: Guiding Principles for On-site Inspections of the Quality Management Standards for Online Sales of Medical Devices (26 September 2025);…
An update of the standards used for the sanitary control and verification of the conformity of sterile, single-use hypodermic needles and syringes, as previously established in Ministry of Health Exempt Decree No. 1887 of 27 December 2007, have been published1.…
On 26 June 2025, the US Food and Drug Administration (FDA) published another update to its list of recognised consensus standards entitled Modifications to the List of Recognized Standards, Recognition List Number: 0641. These standards are intended to help manufacturers…
Comments are being accepted until 16 September 2025 on the following four draft African standards (DARS): DARS 2162:2025, Medical cotton swabs – Specification, which specifies requirements, sampling and test methods for medical cotton swabs, excluding non-woven cotton swabs1. DARS…
Technical Reference Document TR-007, Software Medical Devices and Cybersecurity, has been updated and became effective immediately1. This TR provides an overview and definitions of medical device software, including software in a medical device (SiMD) and software as a medical device…
A new Technical Reference Document – TR-009, Personalised Medical Devices – has been published1 and became effective immediately. This document aims to provide definitions and examples of personalised medical devices, and to identify and describe different categories of devices that…
To further optimise the medical device standard system, the National Medical Products Administration has decided to abolish1 the following three medical device industry standards: YY/T 0605.7-2007, Surgical Implants – Metal Materials – Part 7: Malleable and Cold-Worked Cobalt-Chromium-Nickel-Molybdenum-Ferroalloys (date…
The National Medical Products Administration has issued the Quality Management Standards for Online Sales of Medical Devices, which will come into effect on 1 October 20251,2. These Standards are an important measure to implement the provisions of laws and regulations…
On 25 June 2025, 38 medical device industry standards (revisions and new documents) were approved and published1. The standard number, name, status and implementation date are detailed in Table CN1. Table CN1. 38 new and revised medical device industry standards…
In order to further strengthen the role of medical device registration review guidelines in registration applications and technical reviews, the Center for Medical Device Evaluation has created and published a medical device registration review guidelines compilation plan for 2025 (see…
The following Guiding Principles have been finalised and published by the National Medical Products Administration1 and the Center for Medical Device Evaluation2: Guiding Principles for the Classification and Definition of Medical Devices Containing Light Sources for Myopia Control and…
A period of public consultation has been held on the following Key Points and Guiding Principles that have been released by the Center for Medical Device Evaluation1: Guiding Principles for the Registration and Review of Helicobacter pylori Resistance Gene…
Introduction Regulatory frameworks for medical devices have historically balanced innovation with patient safety. Yet, as medical technologies become increasingly modular, software enabled and patient specific, traditional regulatory models – rooted in predicate comparison or exhaustive clinical trials – struggle to…
On 20 March 2025, 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: 0631. These standards are intended to help…
The final version of Official Mexican Standard NOM-241-SSA1-2025, Good manufacturing practices for medical devices, was published in April 20251. Among the modifications contained in this latest version of the standard is the elimination of the chapter relating to the classification…
The existing mandatory Israeli Standard SI 867 – Clinical thermometers: Metallic liquid-in-glass thermometers with maximum device is to be declared voluntary1. This declaration aims to remove unnecessary trade obstacles and lower trade barriers. These thermometers are listed in Israel’s Medical…
Comments are being sought on proposals to make the following Israeli Standards (SI) voluntary instead of mandatory, in an effort to remove unnecessary trade obstacles and lower trade barriers: SI 1147 – Elastic bandage: General requirements1; SI 1147 Part…
Five parts of the Israeli Standard SI 1268 on syringes and needles are to become voluntary instead of mandatory to remove unnecessary trade obstacles and lower trade barriers: SI 1268 Part 3 – Syringes and needles: Sterile hypodermic syringes…
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…
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 –…
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…
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…
The Food and Drug Administration (FDA) has updated its ‘Recognized Consensus Standards’ database (List 63)1, which includes, among other changes, three newly recognised standards for medical device sterilisation and interoperability: ISO 11737-3, Sterilization of health care products – Microbiological…
