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…
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…
The EN ISO 15883 series of standards describes the design and functionality of washer-disinfectors used to disinfect medical tools. Part 5 of this series, which was previously published as a Technical Specification, has been completely updated and published as EN…
The fourth edition of ISO 10993-10:2021, Biological evaluation of medical devices – Part 10: Tests for skin sensitization, was published in November 20211. This 48-page standard specifies the procedure for the assessment of medical devices and their constituent materials regarding…
On 8 September 2021, the European Committee for Standardization (CEN) made available EN ISO 13485:2016/A11:20211. This revised standard for medical device Quality Management Systems has been amended to include new Annexes ZA and ZB that link the requirements of Regulation (EU) 2017/745…
Two guidance documents have been drafted by the Food and Drug Administration (FDA) to identify performance criteria and testing methodologies for additional device types under the Safety and Performance Based Pathway1. These draft guidances are: Denture Base Resins –…
The consolidated Metrological Technical Regulation for clinical thermometers of thermometric liquid in glass was published as Ordinance No. 323 of 23 July 2021 in the Official Journal of 27 July 20211. The consolidated Metrological Technical Regulation establishes the minimum conditions…
Decree 42 (exempt) incorporates portable automatic external defibrillators into the sanitary control system1 established in Article 111 of the Sanitary Code and its regulations, approved by Decree No. 825 of 1998. This change will take effect on 17 March 2022.…
A total of 63 medical device industry standards have been reviewed, approved and published in September 20211. Eight of the standards are mandatory and the remainder are recommended. Reference 1. https://www.nmpa.gov.cn/directory/web/nmpa/images/1631177365624030840.docx
Egyptian Standard ES 3241-1, Injection equipment for medical use – Part 1: Ampoules for injectables, was published on 13 June 2021 and entered into force on 14 June 20211. This standard is technically identical to ISO 9187-1:2010 (confirmed in 2015).…
A list of Indian Standards published under the Medical Equipment and Hospital Planning Department (MHD) of the Bureau of Indian Standards has been compiled for easy reference1. The standards are divided into the following categories: surgical instruments (MHD-01) –…
To ensure the protection of medical, occupationally exposed personnel and members of the public from the harmful effects of using ionising radiation devices in planned exposure situations, an Administrative Order has been proposed1 to update the national basic radiation protection…
Draft Rwanda Standard DRS 478:2021, Medical ultrasound gel – Specification, establishes the requirements, sampling and test methods for medical ultrasound gels1. A period of public consultation has been held on the draft standard but no date of adoption or entry…
Comments are being accepted until 13 November 2021 on Draft Ugandan Standard DUS 706:2021, Non-woven surgical dressing – Specification (second edition)1. This DUS specifies the requirements, sampling and test methods for three types of non-woven surgical dressings, namely unpadded swabs,…
On 15 June 2021, three Draft Ugandan Standards (DUSs) were adopted as Ugandan Standards (USs). DUS 2287:2020 was adopted as US 2287:2021, Alcohol swabs – Specification (first edition)1, which specifies the requirements, sampling and test methods for alcohol swabs, also…
A first amendment has been drafted1,2 for ISO 10993-18:2020, Biological evaluation of medical devices – Part 18: Chemical characterization of medical device materials within a risk management process. This proposed amendment is undergoing voting in the ballot stage until 8…
Commission Implementing Decision (EU) 2021/1182 of 16 July 20211 includes references to five harmonised standards for medical devices drafted in support of Regulation (EU) 2017/745 (the MDR). Following a request from the European Commission, the European Committee for Standardization (CEN)…
A new standard, QFIS 001:2021, has been developed to identify and define requirements to ensure a medical device functions safely, and that the safety properties and characteristics of the device do not deleteriously affect its function resulting in an inferior…
On 9 July 2021, the Food and Drug Administration updated its Technical Considerations for Non-Clinical Assessment of Medical Devices Containing Nitinol final guidance to clarify acceptance criteria for nitinol transformation temperatures when evaluating nitinol pseudoelastic properties1. The previous version of…
On 29 April 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: 0551. These standards are intended to help manufacturers…
Guidance on key performance aspects of medical/surgical face masks and respirator standards has been updated in May 2021 and requirements on particulate filtration efficiencies have been inserted1. This updated guidance is intended to assist manufacturers in choosing appropriate standards and…
The National Medical Products Administration has updated its catalogue of medical device standards, which are technical specifications that should be followed during the development, production, operation, use, supervision and management of medical devices1. At the end of May 2021, there…
All medical devices that are locally manufactured in, or imported into, the Philippines must refer to and comply with relevant product standards before a Certificate of Medical Device Notification or a Certificate of Medical Device Registration can be issued for…
A second edition of Draft Uganda Standard DUS 883-1: 2021, Single-use medical examination gloves – Part 1: Specification for gloves made from rubber latex or rubber solution1, has been circulated for public comment and is expected to be adopted on…
The following two Draft Ugandan Standards (DUSs) on surgical clothing have been drafted and are set for adoption on 1 December 2021: DUS 966-1:2021, Surgical clothing – Specification – Part 1: Surgical gowns and drapes, Second Edition1 This draft…
In a collaboration between the British Standards Institution (BSI) and the Association for the Advancement of Medical Instrumentation (AAMI), a guidance document has been drafted on the application of ISO 14971 to artificial intelligence (AI) and machine learning (ML)1. The…
In July 2021, the fourth edition of ISO 15223-1:2021, Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General Requirements, was published1. This fourth edition cancels and replaces the third edition…
On 15 April 2021, the following three Commission Implementing Decisions for harmonised standards in support of the current Directives on medical devices were published in the Official Journal: Commission Implementing Decision (EU) 2021/6091, amending Implementing Decision (EU) 2020/439 with…
In April 2021, the Medical Device Coordination Group published MDCG 2021-5, Guidance on standardisation for medical devices1. This new guidance does not really present any new information, it merely consolidates information and attempts to present it in a clear and…
The European Commission has adopted a Commission Implementing Decision1 on a standardisation request to the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (CENELEC) in support of Regulation (EU) 2017/745 on medical devices and Regulation (EU)…
On 3 March 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: 0541. These standards are intended to help manufacturers…
The following two Egyptian Standards concerning injection containers and accessories entered into force on 15 January 20211: ES 4436-1, Injection containers and accessories – Part 1: Injection vials made of glass tubing, which is technically identical to ISO 8362-1:2018; ES…
The Department of Health and Family Welfare has issued a proposal1 to allow American Standard Test Methods (ASTMs) to be used for demonstrating conformity to the requirements of the Medical Devices Rules, 2017. According to the current Rule 7 of…
From 1 January 2025, only ISO 13485 certificates issued by third-party certification bodies accredited by the Singapore Accreditation Council (SAC) will be accepted for medical device licence applications1. By the end of 2021, certification bodies should aim to achieve SAC…
Comments are being accepted until 8 May 2021 on a Draft Ministerial Regulation1 that mandates single-use hygienic face masks must conform to the standard for single-use hygienic face masks, namely TIS 2424:2562(2019). This standard applies to single-use hygienic face masks…
The following two Draft Ugandan Standards (DUSs) concerning thermometers have been circulated for public comment1: DUS 2299:2021, Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature, First Edition This draft standard covers electronic instruments intended for intermittent…
With effect from 1 March 2021, the following medical equipment must undergo inspection/testing of their safety and technical features1: ventilators; anaesthesia machines with breathing systems; electric scalpels; incubators for newborn babies; defibrillators; artificial kidney machines. The Ministry of…
ISO/TS 22421:2021, Sterilization of health care products — Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities, sets out the common requirements for sterilisers used for terminal sterilisation of medical devices in healthcare facilities1. The…
In April 2021, a new 72-page standard was published on information to be supplied by the manufacturer with a medical device1. ISO 20417:2021 sets out the requirements for the identification and labels on a medical device or accessory, the packaging,…
On 1 June 2021, the Draft Ugandan Standard DUS 2276: 2020, Medical cotton swabs – Specification (first edition), is expected to be adopted in the country, although as yet no date of entry into force has been set1. This draft…
In January 2021, the first edition of the guidance MDA/GD/0033, Medical Face Mask and Respirator, was published1. This guidance document specifies the requirements for medical face masks and respirators that are regulated under the Medical Device Act (Act 737). Generally,…
KS 2925: 2020, which sets out the requirements for stainless steel and enamelled iron kidney trays, was adopted on 4 December 20201 through Gazette Notice No. 10268. A kidney dish (British English) or emesis basin (American English) is a shallow…
A partial amendment of the Ministerial Order for the Standard of Manufacturing Control and Quality Control for Medical Devices and In vitro Diagnostic Pharmaceutical Products (Ministerial Order No. 169 of 2004, the QMS Ministerial Order) has been proposed1. The amendment would…
Comments are being accepted until 12 February 2021 on a draft Egyptian standard that sets out requirements and test methods for external limb prostheses and external orthoses1. The draft Egyptian standard is technically identical to ISO 22523:20062. The draft standard…
Interested parties had until 12 January 2021 to submit comments on the following draft standards1: National Standard of the People’s Republic of China, Copper-bearing Contraceptive Intrauterine Devices – Requirements and Tests This draft standard applies to disposable copper-bearing contraceptive…
Guidelines for the technical review of seven types of in vitro diagnostic medical devices (IVDs) have been published through Announcement No. 80 of 2020, dated 9 December 20201. Devices covered by these guidance documents are: household IVDs; specific protein…
In light of the COVID-19 pandemic and the difficulty of carrying out overseas inspections, Argentina will accept1 ISO 13485 or Medical Device Single Audit Program (MDSAP) certificates instead of certificates issued by the National Administration of Drugs, Food, and Medical…
On 21 January 2021, the Food and Drug Administration (FDA) updated its recognised consensus standards database1. New and revised recognised standards were added, as well as revisions to some standards’ extent of recognition or transition periods. Nine standards included in…
The following three device-specific final guidance documents have been released1 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 Pathway2: …
