Interested parties have until 16 March 2021 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 three standards, adding 14 new standards, and replacing…
Two final guidance documents have been published1 to provide performance criteria for the following device types in support of the Safety and Performance Based Pathway: Conventional Foley catheters2 that are intended for drainage and/or irrigation of the urinary tract.…
Recognition and Withdrawal of Voluntary Consensus Standards; Guidance for Industry and Food and Drug Administration Staff has been published to provide guidance on the procedures the Center for Devices and Radiological Health (CDRH) follows when it receives a request for…
The unique properties of nitinol have prompted the Food and Drug Administration to issue new guidance1,2 outlining the specific technical considerations for devices that have at least one patient contacting component comprised of nitinol. The guidance provides clarity and consistency…
In light of the COVID-19 pandemic, steps are being taken to prevent a shortage of face masks for medical and hospital staff in El Salvador. As part of these efforts, Salvadoran Technical Regulation RTS 11.03.01:20, Medical supplies. Face masks for…
Two draft standards affecting medical suction equipment have been proposed1. Draft Egyptian Standard ES 6134-2, Medical Suction Equipment – Part 2: Manually Powered Suction Equipment, is technically identical to ISO 10079-2:2014. It specifies the safety and performance requirements for manually…
A total of 34 medical device industry standards were approved and published in October 20201. Three of the standards are mandatory and the remainder are recommended. A list is provided in Table 1. Table 1. New Chinese medical device…
Comments are being accepted until 4 December 2020 on several standards that specify basic safety and performance requirements for various medical electrical equipment1: National Standard of the People’s Republic of China, Medical Electrical Equipment – Part 2-39: Particular Requirements…
Comments were accepted until 30 October 2020 on two new Chinese standards concerning medical electrical dental equipment1: National Standard of the People’s Republic of China, Medical Electrical Equipment – Part 2-60: Particular Requirements for the Basic Safety and Essential…
Comments are being accepted until 20 November 2020 on four draft Egyptian Standards (ESs) for intravascular catheters1. ES 6788-1, Intravascular Catheters – Sterile and Single-use Catheters – Part 1: General Requirements, is technically identical to ISO 10555-1:2013 and ISO 10555‑1:2013/Amendment 1:2017. It…
Israeli Mandatory Standard SI 60601 Part 2.4, Medical electrical equipment: Particular requirements for the basic safety and essential performance of cardiac defibrillators, was published on 17 May 2020 and entered into force on 16 July 20201. This revision of the…
DKS 2925: 2020, Kidney Trays – Specification, sets out the requirements for stainless steel and enamelled iron kidney trays1. A kidney dish (British English) or emesis basin (American English) is a shallow basin with a kidney-shaped base and sloping walls…
Six guidance document revisions have been issued recently by the Saudi Food and Drug Authority (SFDA): MDS-G21, Guidance on Requirements of Shipments Clearance at Ports of Entry, version 4.0, 20 October 20201 The purpose of this guidance is to clarify the…
Several frequently asked questions/ambiguities on the performance evaluation of point-of-care COVID-19 serology antibody test kits have been addressed by the South African Health Products Regulatory Authority in a Communication to stakeholders (MD024)1. The questions/ambiguities that have been addressed are as…
Draft Tanzania Standard TDC 9(6784) P3, Textiles – Surgical face masks – Specification, has been developed1 to specify the performance requirements, sampling, and test methods for surgical face masks intended to limit the transmission of infective agents from staff to…
A Ugandan standard has been drafted to specify the requirements, test methods, and sampling for petrolatum gauze1, also known as paraffin gauze or vaseline gauze. This Draft Ugandan Standard DUS 2229-2, Surgical gauze – Specification – Part 2: Petrolatum (first edition)…
ISO 14155, Clinical investigation of medical devices for human subjects – Good clinical practice, has been updated1 to help manufacturers comply with the requirements for Good Clinical Practice (GCP) in the design, conduct and reporting of clinical investigations carried out…
A new, 43-page guidance has been released1 for manufacturers who are planning and performing their post-market surveillance activities. Other organisations such as importers, distributors and reprocessors who are connected to the manufacturer in the product lifecycle and who play a…
Quality in 510(k) Review Program Pilot The Quality in 510(k) Review Program Pilot is an alternate method for submitting a pre-market notification submission (510(k)) to the Food and Drug Administration (FDA) for certain device types. The method uses the FDA’s…
Introduction Artificial intelligence (AI) is making its way into our daily lives: through image search functions, digital voice assistance, and even in our personally recommended list of items to watch on popular streaming services, often without us being aware of…
A Standardisation Request for Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) was adopted by the European Commission on 15 May 2020 as Implementing Decision C(2020) 25321. However, this Standardisation Request was…
The Medicines and Healthcare products Regulatory Agency (MHRA) continues to produce supporting guidance and information for industry, healthcare professionals and patients covering the COVID-19 pandemic. The most recent documents are as follows1: How tests and testing kits for coronavirus…
Amendment No. 11,2 to the first revision (1R)3 of Ecuadorian Technical Regulation RTE INEN No. 186, Electromedical equipment and systems, has been published under Resolution MPCEIP-SC-2020-0177‑R of 10 June 2020 and entered into force on 16 June 2020. The revised…
Comments are being accepted until 25 August 2020 on Draft Ecuadorian Technical Regulation PRTE INEN No. 262, Assistive products for walking1. This draft Technical Regulation, which is based on internationally accepted standards, establishes the requirements to be met by assistive…
The repeal of three Technical Regulations concerning dental equipment has been postponed until August 2020. These documents are as follows: Ecuadorian Technical Regulation RTE INEN No. 199, Dentistry equipment, will be repealed on 5 August 20201; Ecuadorian Technical Regulation RTE…
In response to the COVID-19 public health emergency, the Directorate General of Medicines, Supplies and Drugs (DIGEMID) has issued a few legislative documents to support access to critical products. The regulatory documents affecting medical devices are as follows1: Ministerial…
The following three medical electrical equipment standards affecting X-ray equipment have been circulated for public comment until 21 September 2020: National Standard of the People’s Republic of China, Medical Electrical Equipment – Part 2-44: Particular Requirements for the Basic…
Through publication of Ministerial Decree No. 174/20201, medical device manufacturers and importers have been given a six-month transition period to comply with the following Egyptian standards: ES 1885-4, Sterile hypodermic syringes – Safety requirements and test methods. Part 4: Syringes…
Comments are being accepted until 7 September 2020 on a draft amendment1 of the Public Notice on Standard Specifications of Medical Devices. These changes would strengthen the safety standards for light emitting diode (LED) masks and adjust the minimum thickness…
In mid-May 2020, three Ugandan Standards (US) were proposed for almost immediate adoption and entry into force. US EN 14763:2020, Medical face masks – Requirements and test methods, specifies the construction, design and performance requirements, and test methods for medical…
ISO/TR 24971:2020, Medical devices – Guidance on the application of ISO 14971, was published in June 20201 to provide updated guidance on the development, implementation and maintenance of a risk management system for medical devices, including in vitro diagnostic medical…
Commission Implementing Decision (EU) 2020/3501 has amended Decision 2002/364/EC2 with respect to the definitions of first-line assays and confirmatory assays, as well as the requirements for devices for self-testing and requirements for human immunodeficiency (HIV) and hepatitis C virus (HCV)…
Updated lists of standards harmonised under the Active Implantable Medical Device Directive (90/385/EEC), the Medical Device Directive (93/42/EEC) and the In Vitro Diagnostic Medical Device Directive (98/79/EC) have been cited in the Official Journal in the form of three Commission…
A period of public consultation is being held until 4 May 2020 on draft performance criteria for soft (hydrophilic) daily wear contact lenses, which could be used to support applications submitted under the Safety and Performance Based Pathway1,2. Under this…
The first revision (1R) of Ecuadorian Technical Regulation RTE INEN No 186, Electromedical equipment and systems, has been published under Resolution No. 19 099 of 13 December 2019 and will enter into force six months after the working day following…
Three Technical Regulations concerning dental equipment have been repealed and are now null and void1-3. These documents are as follows: Ecuadorian Technical Regulation RTE INEN No 199, Dentistry equipment; Ecuadorian Technical Regulation RTE INEN No 205, Dental chairs; Ecuadorian…
On 30 March 2020, 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: 0531. These standards are intended to help…
Three draft resolutions from 16 September 2019 were adopted on 6 March 2020 to update the minimum requirements for the identity and quality of certain medical devices. The proposed revision of Resolution RDC No 3, dated 4 February 2011, which…
On 20 March 2020, the National Medical Products Administration published its 2020 Medical Device Industry Standard Revision Program1. Table 1 lists the 86 standards, of which there are nine mandatory standards (five new and four amendments) and 77 recommended standards…
Comments are being accepted until 12 May 2020 on three National Standards concerning medical electrical equipment, namely: Medical Electrical Equipment – Part 1: General Requirements for Basic Safety and Essential Performance1, which applies to medical electrical equipment and medical electrical…
An Egyptian standard has been drafted1 in line with the technical requirements of ISO 7886-4:2018. This draft Egyptian standard, Sterile hypodermic syringes – Safety requirements and test methods Part 4: Syringes with re-use prevention feature, specifies requirements for sterile single-use hypodermic syringes…
An 18-page draft Egyptian standard entitled, Sharps injury protection – Requirements and test methods – Sharps protection features for single-use hypodermic needles, Introducers for catheters and needles used for blood sampling, has been circulated for public comment1. No date of…
A period of public consultation has been held on a revision of the Israeli Mandatory Standard SI 60601 Part 2.4, Medical electrical equipment: Particular requirements for the basic safety and essential performance of cardiac defibrillators1. This draft standard revision adopts the…
A number of new standards for medical devices have been published by the Kuwait Standard & Metrology Department in line with internationally accepted standards1. For each of these standards, a 60-day comment period has been opened. It is usual for…
The second version of MDS-G46, Guidance on Requirements for Medical Masks – Recognized Standards, was published on 9 April 20201. The guidance specifies and clarifies the requirements and recognised standards for obtaining a Medical Devices Marketing Authorization for a medical…
ISO 15223-1:2016, Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements, is undergoing revision1. It is currently at the Draft International Standard (DIS) ballot stage, with voting…
On 20 April 2020, the Saudi Food and Drug Authority (SFDA) issued MDS-G47, Guidance on Requirements for Ventilators, Ventilator Tubing Connectors, and Ventilator Accessories – Recognized Standards1. This guidance specifies and clarifies the requirements and recognised standards for obtaining a…
Introduction Nitinol is an alloy of nickel and titanium with major applications in the medical device industry due to its unique pseudoelasticity and shape memory behaviour. Nitinol has been used extensively in cardiovascular stents, heart valves, guidewires, etc, as well…
Comments are being solicited until 7 February 2020 on proposed performance criteria for magnetic resonance (MR) coils in support of the Safety and Performance Based Pathway1,2. Applicants planning to submit a pre-market notification (510(k)) using the Safety and Performance Based…
On 23 December 2019, the Food and Drug Administration (FDA) updated its Recognized Consensus Standards database1. In total, 102 standards were added, including ISO 14971:2019, Medical devices – Application of risk management to medical devices. Reference 1. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm
