In October 2022, Announcement No. 871 detailed 20 new and revised voluntary medical device industry standards (see Table CN1a). Similarly, in January 2023, 32 medical device industry standards were approved and announced in Announcement No. 82 (Table CN1b). …
Commission Implementing Regulation (EU) 2022/23461, dated 1 December 2022, specifies the Common Specifications for the groups of products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745 on medical devices (MDR). The Common Specifications for each…
On 10 August 2022, 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: 0581. These standards are intended to help manufacturers…
ANSI/AAMI ST98:2022, Cleaning validation of health care products – Requirements for development and validation of a cleaning process for medical devices1, has been published to replace TIR30:2011/(R)2016, A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable…
The Centre for Medical Device Evaluation has published several new guidelines1 as follows: Guidelines for the Registration and Review of the Analytical Performance Evaluation of In Vitro Diagnostic Reagents for Quantitative Detection (26 August 2022); Key Points for the…
The Centre for Medical Device Evaluation has published several new draft guidelines1 for public consultation, as follows: Guidelines for the Technical Review of Laparoscopic Endoscopic Surgical Systems – Part 1: Surgical Instruments (20 July 2022); Guidelines for the Registration…
In August 2022, Announcement No. 661 detailed 18 new and revised voluntary medical device industry standards (see Table CN1). [Table CN1. New and revised voluntary industry standards listed in Announcement No. 66] Standard number Standard name Type Date of…
On 9 September 2022, the National Medical Products Administration announced that the following 20 mandatory industry standards would be abolished1: YY 1075-2007, Rigid uterine endoscope YY 1082-2007, Hard articular endoscope YY 91083-1999, Fibre-guided light-guided cystoscope YY 0154-2013, Spring-loaded full-opening safety…
Interested parties have until 8 October 2022 to submit comments on the following two draft industry standards, which were released for public consultation on 10 August 20221: Clinical Evaluation of Medical Devices – Terms and Definitions; and Clinical Trials…
It has been announced that the following Draft Ugandan Standards have been withdrawn with effect from 14 May 2022: FDUS 966-1, Medical devices – Surgical gowns, drapes and clean air suits – Part 1: General requirements1; FDUS 883-1: 2009,…
The growing importance of climate concerns and the role and responsibility of industry in international initiatives is stimulating greater interest in the fundamental environmental properties and characteristics of products than previously. Until recently, attention concentrated on environmental management systems described…
Commission Implementing Decision (EU) 2022/757 of 11 May 20221 includes references to two additional harmonised standards for medical devices to support compliance with Regulation (EU) 2017/745 (the MDR): EN 285:2015+A1:2021, Sterilization – Steam sterilizers – Large sterilizers; EN ISO 14971:2019,…
Interested parties have until 23 August 2022 to submit comments on Health Canada’s proposed changes to the Medical Device Directorate’s List of Recognised Standards for medical devices1. The proposed changes include removing one standard, adding 29 new standards, and replacing…
In June 2022, another update to the recognised standards database, List 58, was released1 to add new standards and new versions of recognised standards, as well as revisions to some standards’ extent of recognition. The next Federal Register notice with…
New editions of the standards for medical device interoperability – the AAMI/UL 2800 series – have been published as joint standards by the Association for the Advancement of Medical Instrumentation (AAMI) and UL Standards & Engagement1. Four separate standards were…
The first revision of Ecuadorian Technical Regulation RTE INEN No. 121, Orthoses and prostheses, has been repealed and declared null and void with effect from 10 May 20221. Technical Regulation No. 121 established requirements that external limb prostheses and orthoses need…
Announcement No. 39 of 2022 announced the availability of 55 industry standards – four mandatory industry standards (YY) and 51 voluntary industry standards (YY/T)1. Additionally, it specified certain revisions of the following two standards: YY 9706.241-2020, Medical electrical equipment…
A 60-day comment period was opened on 18 May 2022 for the 32-page National Standard of the People’s Republic of China, Medical electrical equipment – Part 2-71: Particular requirements for the basic safety and essential performance of functional near-infrared spectroscopy…
On 4 February 2022, Uganda Standard US 706:2022, Non-woven surgical dressing – Specification (second edition) was published1 following the adoption of Draft Ugandan Standard DUS 706:2021. This standard specifies the requirements, sampling and test methods for three types of non-woven…
Final Draft Kenyan Standard FDKS 2925:2021, Textiles – Reusable sanitary towels – Specification (Second Edition 2022), specifies the requirements and test methods for reusable sanitary towels (including reusable panty liners) for external use1. When finalised, this second edition will cancel…
A revision of the mandatory standard SI 1313 on tampons for menstruation has been proposed1. This draft standard revision adopts the Australian Standard AS 2869:2008 with national deviations, as detailed in the standard Hebrew section, and differs significantly from the…
Ministerial Decree No. 524/2021 confirms1 that Egyptian Standard ES 6576, Anaesthetic and respiratory equipment – Breathing sets and connectors, is mandatory, and producers and importers have been provided with a six-month transition period in which to comply with the new…
Interested parties have until 4 June 2022 to submit comments on the following two standards: National Standard of the People’s Republic of China, Medical Electrical Equipment – Part 2-90: Particular Requirements for Basic Safety and Essential Performance of Respiratory…
Announcement No. 6 of 2022 announces the availability of one revised mandatory industry standard (YY) and two new voluntary industry standards (YY/T)1. These medical device standards are as follows: YY 9706.274-2022, Medical electrical equipment – Part 2-74: Special requirements…
The National Medical Products Administration has published several new final guidelines and draft guidelines1,2. The final guidelines are as follows: Guidelines for the registration and review of high strength and toughness pure titanium orthopaedic internal fixation implants (1 April…
Guidance has been provided on the preparation of technical requirements for medical devices, including in vitro diagnostic reagent products, that need to be included as part of an application for registration or filing1. The guidelines outline general requirements for the…
The second revision of Technical Regulation (RTE INEN) No. 049, Natural rubber latex male condoms, has been repealed and declared null and void1. This repealed standard had established the requirements to be met by natural rubber latex male condoms prior…
On 22 April 2022, 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: 0571. These standards are intended to help manufacturers…
The following four device-specific final guidance documents have been released to provide performance criteria for pre-market notification (510(k)) submissions to support the optional Safety and Performance Based Pathway, as described in the guidance entitled Safety and Performance Based Pathway1: …
A first revision has been issued1 for the Medical Device Coordination Group (MDCG) 2021-21 guidance on the performance evaluation of SARS-CoV-2 in vitro diagnostic medical devices (IVDs), in the context of conformity assessment under either Directive 98/79/EC or Regulation (EU)…
On 9 March 2022, the comment period closed for the submission of feedback on the draft Common Specifications for certain Class D (highest risk) in vitro diagnostic medical devices (IVDs)1. Adoption of the Common Specifications by the Commission was planned…
Joint Working Group 1 (JWG1) of ISO/TC 210 and IEC/SC 62A is currently working on a revision1 of ISO 14971:2007 and its companion technical report ISO/TR 24971:2013, which are concerned with the application of risk management to medical devices. As for…
On 1 May 2017, the China Food and Drug Administration’s standard YY/T0287-2017/ISO13485:2016, Medical devices – Quality management systems – Requirements for regulatory purposes, came into effect1. The Chinese standard is equivalent to the internationally-harmonised standard ISO 13485:2016. It specifies that the…
Minor updates have been made to GD207, Guidance on the Content of ISO 13485 Quality Management System Certificates Issued by Health Canada Recognized Registrars1. The new version, dated 14 March 2017, now includes references to ISO 13485:2016 (CAN/CSA-ISO 13485:16), as…
Comments are being accepted until 19 March 2022 on a draft Commission Implementing Regulation1 laying down Common Specifications for the groups of products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745 on medical devices (MDR).…
The European Commission’s Comitology Committee has confirmed that draft Common Specifications for certain Class D (highest risk) in vitro diagnostic medical devices (IVDs) will be released soon for public consultation, with adoption by the Commission currently set for the first…
Commission Implementing Decision (EU) 2022/6 of 4 January 20221 includes references to nine additional harmonised standards for medical devices to support compliance with Regulation (EU) 2017/745 (the MDR), including a reference for EN ISO 13485: EN ISO 10993-9:2021, Biological…
Industry and Food and Drug Administration (FDA) staff have been provided with draft guidance1,2 to help assess the credibility of computational modelling – defined as trust in the predictive capability of a computational model – used to support medical device…
A final guidance has been published entitled Non-Clinical and Clinical Investigation of Devices Used for the Treatment of Benign Prostatic Hyperplasia (BPH)1,2. This guidance identifies the key features of non-clinical and clinical investigational plans used to support Investigational Device Exemption…
Guidance has been drafted to set out the technical considerations for medical devices with Physiologic Closed-Loop Control (PCLC) technology1,2. It highlights technical considerations for the development of medical devices employing PCLC technology to ensure safe and effective use and provides…
On 9 December 2021, 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: 0561. These standards are intended to help manufacturers…
Draft Peruvian Metrology Standard (PNMP) No. 02X:202X, Ophthalmic instruments – Impression and applanation tonometers – Part 1: Metrological and technical requirements; Part 2: Test procedures; and Part 3: Test report format (first edition) has been circulated for public comment1. This…
Comments were accepted until 3 January 2022 on the following two Draft East African Standards (DEAS): DEAS 1069:2021, Cotton ear bud – Specification (first edition), which specifies requirements, sampling and test methods for cotton ear buds1; DEAS 1070:2021, Medical…
An appendix to Announcement No. 144 of 2021 contains 19 new and revised voluntary industry standards that were adopted in December 20211. These medical device standards are listed in Table CN1 overleaf. Table CN1. New and revised voluntary industry standards…
Interested parties have until 19 February 2022 to submit comments on the standard Sterilization of Health-Care Products – Ethylene Oxide – Requirements for the Development, Validation and Routine Control of a Sterilization Process for Medical Devices (GB 18279-20XX)1. This draft…
The National Medical Products Administration has published a number of new final guidelines and draft guidelines1,2. The final guidelines are as follows: Guidelines for the Registration and Review of Fluorescence Immunochromatography Analysers, 28 December 2021; Guidelines for the Registration and…
Specifications, test methods and performance criteria to be complied with by specific medical equipment have been drafted for a period of public consultation1. This document applies to the following Class I devices: mechanical walkers (classification code O.3825), specifically walking…
An amendment has been drafted to the Medical Devices Rules, 2017 that, if finalised, would temporarily ease the registration requirements concerning ISO 13485 certification. Under the draft proposal, applicants have until 28 February 20221 (a previous draft had stated 30…
Comments were accepted until 16 January 2022 on the following two Draft East African Standards (DEAS): DEAS 1069:2021, Cotton ear bud – Specification (first edition), which specifies requirements, sampling and test methods for cotton ear buds1; DEAS 1070:2021, Medical…
Comments were accepted until 3 January 2022 on the following two Draft East African Standards (DEAS): DEAS 1069:2021, Cotton ear bud – Specification (first edition), which specifies requirements, sampling and test methods for cotton ear buds1; DEAS 1070:2021, Medical…
