In communications dated 27 November 20231,2, the Kenya Bureau of Standards confirmed that the following two East African Standards (EASs) have been adopted via Gazette Notice No. 13353 of 29 September 2023: EAS 1069:2021, Cotton ear bud – Specification, which…
In September 2023, a question-and-answer document was published1 on the transitional provisions that apply to products without an intended medical purpose covered by Annex XVI to Regulation (EU) 2017/745 on medical devices (MDR). The purpose of this document is to…
Final guidance has been published on the Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process”1. This guidance replaces the 2000 guidance of the same name and…
Technical Considerations for Medical Devices with Physiologic Closed-Loop Control Technology (PCLC) has been published to highlight the technical considerations for medical devices that use PCLC technology to ensure their safe and effective use1,2. The final guidance provides recommendations for the…
On 10 October 2023, the Food and Drug Administration (FDA) published minor updates to the following magnetic resonance related guidance documents: Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices1; Testing and Labeling Medical Devices for Safety in the…
The following Guiding Principles and Key Points have been issued by the Center for Medical Device Evaluation1: Key Points for the Review of Artificial Intelligence Software Functions in Magnetic Resonance Imaging Systems (15 September 2023); Guiding Principles for the…
A period of public consultation has been held on the following draft guidelines1 issued by the Center for Medical Device Evaluation: Guiding Principles for the Registration and Review of Human Factors Design of Medical Devices (second consultation) (11 October…
A total of 45 medical device industry standards have been approved and published by the National Medical Products Administration1. Details of these standards are provided in Table CN2. CN2. Newly published medical device industry standards Standard number Standard name…
Seven medical device industry standard amendment orders have been approved and issued1. Details of these standards are provided in Table CN3. CN3. Medical device industry standard amendment orders Standard number Standard name Implementation details YY 0068.4-2009 Medical Endoscopy –…
Comments are being solicited on the following five draft medical device standards issued by the National Medical Products Administration: Medical glass thermometer1 This document specifies the requirements, test methods, inspection rules, marks, and operation instructions of medical glass thermometers.…
A revision of the mandatory standard SI 60601-1, Medical electrical equipment – Part 1: General requirements for basic safety and essential performance, has been circulated for public comment1. This draft standard revision adopts the international standard IEC 60601-1 edition 3.2…
Comments are being sought on the draft Kenya Standard DKS 638:2023, Absorbent cotton gauze and gauze bandages – Specification (fourth edition)1. This draft standard specifies the requirements and test methods for bleached absorbent gauze and gauze bandages for use in…
Specifications, test methods and performance criteria to be complied with by specific medical equipment were adopted on 15 August 2023 and will enter into force on 1 September 20241. These criteria apply to the following Class I/II devices: hearing…
In August 2023, the Food and Drug Administration (FDA) published two updates to its list of recognised consensus standards entitled Modifications to the List of Recognized Standards, Recognition List Number: 0591 and 0602. List Number 060 includes the complete recognition…
Commission Implementing Decision (EU) 2023/1410 of 4 July 20231 includes a reference to an additional harmonised standard for medical devices to support compliance with Regulation (EU) 2017/745 (the MDR): EN ISO 10993-10:2023, Biological evaluation of medical devices – Part 10:…
Guidance was published in May 2023 entitled, Non-Clinical Performance Assessment of Tissue Containment Systems Used During Power Morcellation Procedures1,2. This guidance recommends non-clinical test methods, test parameters and test acceptance criteria to support a pre-market notification (510(k)) submission/substantial equivalence determination…
The Architectural and Transportation Barriers Compliance Board has issued a notice of proposed rulemaking1 to remove the sunset provisions in the Board’s existing accessibility standards for medical diagnostic equipment relating to the low-height specifications for transfer surfaces, and replace them…
ANSI/AAMI SW96:2023, Standard for medical device security – Security risk management for device manufacturers1, provides specific requirements for managing security across the total medical device lifecycle. This standard is based on guidance previously published in: AAMI TIR57:2016/(R)2023, Principles for…
By the end of 2024, the Food and Drug Administration (FDA) intends to withdraw Laser Products – Conformance with IEC 60825-1 and IEC 60601-2-22 (Laser Notice No. 50) because newer International Electrotechnical Commission (IEC) standards have since been released. As…
The Supplement for Medical Devices 5.0 to the Mexican Pharmacopoeia has been published1. This Supplement includes the specifications and methods of analysis and/or testing for medical equipment, software (newly added), prostheses, orthoses, functional aids, diagnostic agents, materials and substances for…
Official Mexican Standard NOM-241-SSA1-2021, Good manufacturing practices for medical devices [GMP], entered into force on 20 June 2023, 18 months after its publication in the Official Gazette of the Federation1. The purpose of this standard is to establish the minimum…
The mandatory Official Mexican Standard NOM-010-SSA-2023, Prevention and control of human immunodeficiency virus infection, entered into force on 5 June 20231, repealing Official Mexican Standard NOM-010-SSA2-2010. The purpose of this new standard is to establish updated methods, principles, and operating…
The following guidelines and key points’ documents have been issued by the Center for Medical Device Evaluation1: Guidelines for the Registration and Review of Extracorporeal Membrane Oxygenation (ECMO) Temperature Control Equipment (20 July 2023); Guidelines for the Registration and…
A period of public consultation has been held on the following draft guidelines1 and key points2 documents issued by the Center for Medical Device Evaluation: Key Points for Animal Test Review of Extracorporeal Membrane Oxygenation (ECMO) Consumable Products (10…
On 24 May 2023, the National Medical Products Administration released its 2023 medical device industry standard formulation and revision plan1, which includes 15 mandatory standards and 102 recommended standards. The mandatory industry standards relate to: Medical electrical equipment – Part…
Twenty medical device industry standards have been approved and published by the National Medical Products Administration1. Details of these standards are provided in Table CN1. CN1. Newly published medical device industry standards Standard number Standard name Type Implementation date…
Interested parties may submit comments on a draft update to the 2008 standard GB 22457 on the service of prosthesis fitting1. The standard specifies the service requirements for fitting a prosthesis, such as reception, examination, signing agreements, prescription, fitting cycle,…
Comments are being sought on proposals to declare the following standards voluntary: SI 798-1, Ophthalmic Optics – Uncut Finished Spectacle Lenses – Part 1: Specifications for single-vision and multifocal lenses1; SI 798-2, Ophthalmic Optics – Uncut Finished Spectacle Lenses…
The final rule entitled Radiological Health Regulations: Amendments to Records and Reports for Radiation Emitting Electronic Products; Amendments to Performance Standards for Diagnostic X-ray, Laser and Ultrasonic Products, which was published in January 20231, entered into force on 21 February 2023. To…
Performance criteria and testing methodologies for soft (hydrophilic) daily wear contact lenses have been identified in a new guidance document1,2 under the Safety and Performance Based Pathway. Applicants planning to submit a pre-market notification (510(k)) for certain soft daily hydrogel…
Comments are being accepted until 30 May 2023 on a draft guidance entitled Orthopedic Non-Spinal Bone Plates, Screws, and Washers--Premarket Notification (510(k)) Submissions1,2. The scope of this draft guidance is limited to Class II, orthopaedic, non-resorbable, non-spinal bone plate and…
The Guiding Principles section of the Center for Medical Device Evaluation’s (CMDE’s) website has been optimised for use on mobile telephones and computers, and fully updated with a new interface and new functions1. The new website displays the classification catalogue…
The Center for Medical Device Evaluation has recently published the following guidance documents1: Guidelines for the Registration and Review of Drug-Coated Balloon Dilatation Catheters (13 April 2023); Guiding Principles for the Registration and Review of Intravascular Retrieval Devices (13 April 2023); Guidelines for…
A new medical device industry standard – YY/T 1888-2023, Recombinant humanised collagen – has been approved and published1. It will take effect on 20 July 2023. This standard specifies the quality control, technical requirements, test methods, stability, biological evaluation, packaging,…
On 17 March 2023, the National Medical Products Administration announced the approval of 20 new and revised industry standards1. Table CN1 lists these standards and their implementation dates. CN1. New and revised industry standards Standard number Standard name Type…
A period of public consultation is being held on two draft Chinese standards concerning active implantable medical devices: GB 16174.1, Implants for surgery – Active implantable medical devices – Part 1: General requirements for safety, marking and for information…
Comments have been solicited on the following four draft Egyptian Standards (ES): ES 6134-1, Medical Suction Equipment – Part 1: Electrically Powered Suction Equipment1 This draft standard specifies safety and performance requirements for electrically powered medical and surgical suction…
A new regulation has been drafted to stipulate the requirements that apply to certain medical devices with respect to demonstrating their pre-clinical performance1. The requirements for specifications, test methods and performance will come into effect one year after the regulation…
The following five final documents have been endorsed at the 26th Annual Meeting of the Global Harmonization Working Party (GHWP) held in February 20231: GHWP/SECRETARIAT/F001:2023, Amendment 8 to the Global Harmonization Working Party House Rules GHWP/WG2-WG1-WG3/F001:2023, Categorisation of Changes…
The List of Recognized Standards for Medical Devices has been updated with effect from 15 November 20221. A total of 29 standards have been added, 41 have been amended and one standard (ISO 17664:2004-Ed.2.0, Sterilization of medical devices – Information to be provided…
On 4 January 2023, the Food and Drug Administration (FDA) updated its recognised consensus standards database1. This latest update, known as List 59, includes one new standard and new versions of three recognised standards, as well as extended transition periods…
By means of Directorial Resolution No. 014-2022/INACAL/DM1, the mandatory Peruvian Metrological Standard NMP 025:2022, Ophthalmic Instruments – Printing and Flattening Tonometers, 1st edition has been approved. This standard consists of three parts: technical and metrological requirements; test procedures; and a…
Comments are being sought on Draft Peruvian Metrological Standard PNMP 014:2022 Electrical Energy Measurement Equipment. General Requirements, Tests and Test Conditions. Metering Equipment1, which is in line with IEC 62052-11:2020. The draft standard specifies the requirements and associated tests, with…
On 29 December 2022, three ‘Key Points for Technical Review’ documents were issued by the Centre for Medical Device Evaluation through Announcement No. 47 of 2022 to standardise further the technical review of medical devices. These documents were1: Key…
GB 9706.1-2020, Medical electrical equipment – Part 1: General requirements for basic safety and essential performance, will replace GB 9706.1-2007 on 1 May 20231,2. Its supporting parallel standards have all been released, and the special standards are being released in…
A dynamic List of Mandatory Standards Applicable to Medical Device Products has been issued1 to clarify the mandatory national standards and mandatory industry standards applicable to specific types of medical devices for ease of use by applicants/registrants. If a listed…
ISO/IEC 27001:2022, Information security, cybersecurity and privacy protection – Information security management systems – Requirements, was published on 25 October 20221. This 19-page document specifies the requirements for establishing, implementing, maintaining and continually improving an information security management system within…
The following new and updated guidance documents have been released by the Saudi Food and Drug Administration (SFDA): MDS-G004, Guidance for Requirements of Surgical and Medical Examination Gloves – Recognized Standards (version number 1.1, dated 14 December 2022)1 The…
Comments are being accepted until 19 March 2023 on draft Kenyan standard DKS 2170-1:2022, Medical gases – Specification. Part: 1. Medical Oxygen1. This first part of KS 2170 prescribes the requirements and test methods for compressed medical oxygen intended for…
Four Egyptian Standards (ESs) for intravascular catheters were adopted on 17 November 2022 and entered into force on 6 December 2022. Producers and importers of affected intravascular catheters have been provided with a six-month transition period for compliance courtesy of…
