A new mandatory Israeli Standard, SI 1147, The elastic properties of flat, non-adhesive, extensible fabric bandages1, is set to replace mandatory standards SI 1147, SI 1147-1, SI 1147-2 and SI 1147-3. The newly-proposed SI 1147 would adopt the British Standard…
In order to further optimise the medical device standard system, the National Medical Products Administration has decided to abolish the following two medical device industry standards1: YY/T 0771.1-2020, Medical Devices of Animal Origin – Part 1: Application of Risk…
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 Changes in In Vitro Diagnostic Reagents (24 January 2025);…
Association for the Advancement of Medical Instrumentation (AAMI) technical information report (TIR) 99:2024, Processing of dilators, transesophageal and ultrasound probes in health care facilities, provides guidance on the proper processing of dilators and ultrasound probes in healthcare facilities to assist…
Four, final device-specific guidance documents for the Safety and Performance Based Pathway were published on 30 September 20241, with a fifth published on 15 October 20242: Dental Ceramics – Performance Criteria for Safety and Performance Based Pathway3; Dental Cements…
On 9 September 2024, three sterilisation standards were added to the Food and Drug Administration’s (FDA’s) recognised standards database1 for medical devices to help advance innovation in medical device sterilisation processes: ISO 11737-3:2023, Sterilization of health care products –…
Technical information report (TIR) 109 is being developed by the Association for the Advancement of Medical Instrumentation (AAMI) to define best practices for ensuring packaging integrity during transportation of sterile medical devices1. The new guidance document is expected to be…
An amendment1 to Administrative Order (AO) 2013-0031, Requirements for the Operation of Therapeutic X-ray Facility Utilizing Medical Linear Accelerators has been proposed to address the non-compliance of most therapeutic x-ray facilities with the manpower requirements and to accommodate dedicated radiation…
On 19 September 2024, the following three voluntary standards concerning ophthalmic optics were published and entered into force: SI 798-1, Ophthalmic Optics – Uncut Finished Spectacle Lenses – Part 1: Specifications for single-vision and multifocal lenses1; SI 798-2, Ophthalmic…
Please tell us a little about yourself and your role at Ropes & Gray. I am a partner in Ropes & Gray’s Singapore office. I focus my practice on life sciences and compliance regulatory matters and have advised many life…
Comments have been solicited on the following draft guidance documents prepared by the Global Harmonization Working Party (GHWP) ahead of its 28th annual meeting in December 2024: GHWP/WG7/PD002:2024, Guidance Document for Medical Device Organisations – Product Localisation for Manufacturing…
The five-part EN ISO 18113 series has been published to set out key requirements that manufacturers must provide for information accompanying in vitro diagnostic medical devices (IVDs), including the product label and instructions for use. Specific parts in the standard…
In late August/early September 2024, feedback was sought on a proposed Commission Implementing Regulation1 to amend Implementing Regulation (EU) 2022/1107, which sets out the Common Specifications for certain Class D in vitro diagnostic medical devices (IVDs). For Class D devices…
Commission Implementing Decision (EU) 2024/2631 of 8 October 20241 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) 2024/2631 adds the following…
The National Technical Responsible Unit for Clinical Evaluation Standardisation of Medical Devices has drafted the following two industry standards1: Terminology and Definitions for Real-World Data of Medical Devices; Biological Sample Management Requirements for Clinical Trials of In Vitro Diagnostic…
A three-month consultation period has been held on an updated version of GB 18280.1-2015, the national standard of the People’s Republic of China now entitled, Sterilization of health care products – Radiation – Part 1: Requirements for development, validation and…
A total of 34 medical device industry standards have been approved and published by the National Medical Products Administration1. The standard numbers, titles, and implementation dates are detailed in Table CN1. Table CN1. Newly published medical device industry standards…
The following Guiding Principles have been issued by the Center for Medical Device Evaluation1: Guiding Principles for the Registration Review of Breast Implant Products (2024 revised edition) (17 October 2024); Guiding Principles for the Registration Review of Ultrasonic Diagnostic Imaging…
The National Medical Products Administration has decided to abolish1 the medical device industry standard YY 0605.9-2015, Metallic Materials for Surgical Implants – Part 9: Forged High Nitrogen Stainless Steel. The date of repeal is set for 1 December 2025. …
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 Platelet-Rich Plasma Preparation Devices (21 October 2024); Guiding Principles for…
A national standard for sterile hypodermic needles for single use has been drafted1 and circulated for a 60-day comment period starting on 18 September 2024. This document specifies the requirements for single-use sterile injection needles with a nominal outer diameter…
Interested parties have until 13 November 2024 to submit comments on the proposed alignment of Australia’s Essential Principles for Safety and Performance with the European Regulations1,2. In 2019, the Therapeutic Goods Administration (TGA) held its first consultation on proposed changes…
In June 2024, the Food and Drug Administration (FDA) updated1 its recognised consensus standards database (List 62) to include new standards and new versions of recognised standards, as well as a revision to one standard’s extent of recognition. Highlights of…
The Association for the Advancement of Medical Instrumentation (AAMI) has updated its standard on ethylene oxide sterilisers for use in healthcare facilities to incorporate new technologies and address challenges faced by the industry. ANSI/AAMI ST24:2024, General-purpose ethylene oxide sterilizers with…
Numerous updates have been made in the first revision of MDCG 2021-5, Guidance on standardisation for medical devices1, primarily as a result of moving from the requirements of, and references to, the Directives to the new Regulations. The July 2024…
The following Guiding Principles have been issued by the Center for Medical Device Evaluation1: Guiding Principles for the Registration Review of Traditional Chinese Medicine Pulse Diagnosis Equipment Products (17 June 2024); Guiding Principles for the Registration Review of Medical…
A period of public consultation has been held on the following draft guidelines1 issued by the Center for Medical Device Evaluation: Key Points and Judgment Principles for the Inspection of Medical Device Clinical Trial Projects (Draft for Comments) (14…
A dynamic List of Mandatory Standards Applicable to Medical Device Products has been updated1 to clarify the mandatory national standards and mandatory industry standards applicable to specific types of medical devices for ease of use by applicants/registrants. The 2024 List…
Recently, 36 new medical device industry standards have been released and details are provided in Table CN11. In addition, the following two medical device industry standards have been amended2: YY 0167-2020, Non-absorbable Surgical Sutures, Medical Device Industry Standard No.…
Comments are being sought1 on a revision of the Mandatory Standard SI 60601-1, Medical electrical equipment – Part 1: General requirements for basic safety and essential performance. This draft standard revision adopts the international standard IEC 60601-1:2005+A1:2012+A2:2020 (edition 3.2), with…
The following technical documents have been issued1 recently by the International Medical Device Regulators Forum (IMDRF): IMDRF/RPS WG/N9 Final:2024 (Edition 4), Non-In Vitro Diagnostic Device Table of Contents (nIVD ToC) (25 June 2024); IMDRF/RPS WG/N13 Final:2024 (Edition 4), In…
Commission Implementing Decision (EU) 2024/815 of 6 March 20241 amends the Annex to Implementing Decision (EU) 2021/1182, which lists the references of harmonised standards drafted in support of Regulation (EU) 2017/745 (the MDR). Commission Implementing Decision (EU) 2024/815 adds the…
On 1 March 2024, the Food and Drug Administration (FDA) published an update to its list of recognised consensus standards entitled Modifications to the List of Recognized Standards, Recognition List Number: 0611. Among other changes, List 061 recognises three new…
The following Guiding Principles and Key Points have been issued by the Center for Medical Device Evaluation1: Guiding Principles for the Clinical Evaluation and Registration Review of the Same Types of Absorbable Surgical Sutures (10 April 2024); Guiding Principles…
A period of public consultation has been held on the following draft guidelines1 issued by the Center for Medical Device Evaluation: Guiding Principles for Registration and Review of Laparoscopic Surgery Systems – Part 5: Systems and Software (22 April…
On 19 February 2024, 20 medical device industry standards were approved and published1. Table CN1 lists these standards and their implementation dates. CN1. Newly approved medical device industry standards Standard number Standard name Type Implementation date YY 1001-2024 All…
On 27 March 2024, five medical device industry standards were announced for abolition with immediate effect1. Table CN2 details these standards. CN2. Abolished medical device industry standards Standard number Standard name YY/T 0684-2008 Neurosurgical implants – Identification and packaging of…
A mandatory Egyptian Standard (ES) on implants for surgery was adopted on 18 December 2023 and entered into force on 5 January 2024. Producers and importers of affected devices have been provided with a six-month transition period for compliance courtesy…
On 18 December 2023, a mandatory Egyptian Standard (ES) on infant transport incubators was adopted, and it entered into force on 5 January 20241. Ministerial Decree No. 499/2023 provides producers and importers of affected devices with a six-month transition period…
On 5 January 2024, the following four Egyptian Standards (ESs) entered into force: ES 6134-1, Medical Suction Equipment – Part 1: Electrically Powered Suction Equipment1, which is technically identical to ISO 10079-1:2022; ES 6134-2, Medical Suction Equipment – Part…
First amendments of three mandatory standards in the SI 60601-1 series have been circulated for public comment: SI 60601 Part 2.2, Medical electrical equipment: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and…
Compliance with the revised version of the Japanese Industrial Standard relating to the application of usability engineering to medical devices (JIS T 62366-1:2022) became mandatory on 31 March 20241. IEC 62366-1:2015, Medical devices – Part 1: Application of usability engineering to medical…
Following a public consultation held in 2020 and a review of the comments received during that consultation, Medsafe has decided to recommend1 that the following updated standards for contraceptive devices be published in the New Zealand Gazette: ISO 4074:2015,…
The list of recognised standards that may be used to support applications for permission to market medical devices and supplies was updated in February 20241. Version 3 of MDS-G-020 contains: 18 general standards; 100 standards on anaesthetics, respiration, and…
The Guideline on Testing, Control and Calibration Activities to be Conducted within the Scope of the Regulation on Testing, Control and Calibration of Medical Devices (version 1) has been repealed and replaced by the Guideline on Testing, Control and Calibration…
An update of the standards used for sanitary control and verification of the conformity of hypodermic, sterile and single-use needles and syringes, as previously established in Ministry of Health Exempt Decree No. 1887 of 27 December 2007, has been proposed1.…
The following Guiding Principles have been issued by the Center for Medical Device Evaluation1: Guiding Principles for the Registration and Review of Remote Monitoring Systems (18 January 2024); Guidelines for Clinical Trial Registration Review of Non-Small Cell Lung Cancer-Related Gene Mutation…
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 Technical Review of Ophthalmic Phacoemulsification and Vitrectomy Equipment and Accessories (2023 revised…
A total of 13 medical device industry standards and seven medical device industry standard amendment orders have been approved and published by the National Medical Products Administration1. Details of these standards are provided in Tables CN1a and CN1b. CN1a.…
The National Medical Products Administration has announced the abolition of two medical device industry standards1: YY 0569-2011, Class II Biological Safety Cabinet, which will be repealed as of 1 November 2025; YY/T 0687-2008, Surgical instruments – Non-cutting articulated instruments…
