A period of public consultation has been held on Real-world data for medical devices - Technical Guidelines for Clinical Evaluation (Draft for comments)1. The purpose of these draft guidelines is to standardise and guide the use of real-world data in…
Feedback has been sought on the Basic Principles of Medical Device Safety and Performance (Draft for Solicitation of Comments)1, which has been developed to standardise further the requirements for the review and approval of medical devices, implement a regulatory scientific…
On 18 December 2019, three Draft East African Standards (DEAS) relating to surgical sutures and suture needles were released for public consultation. Comments are being accepted until 9 February 2020 with a proposed date of adoption set for 1 March 2020. The…
Technical Regulation RTE INEN 185, Rotating dental instruments. Diamond instruments, has been repealed and is therefore null and void1. This Technical Regulation, which was first published in August 2014, established the product requirements, packaging and labelling requirements, conformity assessment tests, sampling,…
Three Draft East African Standards (DEAS) relating to surgical sutures and suture needles have been released for public consultation. Comments are being accepted until 15 March 2020 although no proposed date of adoption or entry into force has been specified.…
Three Draft East African Standards (DEAS) relating to surgical sutures and suture needles have been released for public consultation. Comments are being accepted until 7 March 2020; no date of adoption or entry into force has been specified. The three…
A number of symbols that can be used by manufacturers on product labelling in order to comply with Regulation (EU) 2017/745 on medical devices (MDR) have been published on the International Organization for Standardization (ISO) website as part of the…
Five new guidance documents have been published recently by the Saudi Food and Drug Authority (SFDA): MDS-G34, Guidance on Requirements for Unique Device Identification (UDI) for Medical Devices (11 December 2019)1 The purpose of this guidance is to specify the…
Three Draft East African Standards (DEAS) relating to surgical sutures and suture needles have been released for public consultation. Comments are being accepted until 15 March 2020 (extended from 16 February 2020) with a proposed date of adoption set for…
Notification No 2562 of the Ministry of Public Health was issued in December 2019 to amend the regulations concerning silicone breast implants and to align them with international norms1. Silicone breast implants are considered high risk medical devices as they…
On 20 September 2019, the following three Ugandan Standards (US) entered into force: US 1958-1:2019, Surgical sutures – Specification – Part 1: Absorbable1; US 1958-2:2019, Surgical sutures – Specification – Part 2: Non Absorbable2. These two standards specify the…
IEC 63077:2019, Good refurbishment practices for medical imaging equipment, was published on 13 November 20191. IEC 63077:2019 describes and defines the process of refurbishing used medical imaging equipment without changing the finished medical imaging equipment’s performance, safety specifications, or intended use…
In December 2019, ISO 14971:2019, Medical devices – Application of risk management to medical devices, was published1. This standard specifies terminology, principles and a process for risk management of medical devices, including software as a medical device and in vitro…
A list of standards (by category) that will be recognised by the Saudi Food and Drug Authority (SFDA) has been drafted and circulated for comment1. These recognised standards may be used to support medical device pre-market submissions and to satisfy…
Comments are being solicited on a mandatory national standard of the People’s Republic of China concerning ophthalmometers1. This standard specifies the terms and definitions, requirements, and test methods for both continuous and digital indicative ophthalmometers. It is based in part…
Comments are being accepted until 3 November 2019 on a Technical Regulation for Medical Devices and Accessories, which has been drafted by the Ministry of Industry, Commerce & Tourism in coordination with National Health Regulatory Authority (NHRA)1. The purpose of…
The second revision of Ecuadorian Technical Regulation RTE INEN 049, Natural rubber latex male condoms, has been issued pursuant to Resolution No 19 049 of 26 July 2019 by the Under-Secretariat for Quality of the Ministry of Production, Foreign Trade,…
Three draft resolutions, all dated 16 September 2019, have been proposed to update the minimum requirements for the identity and quality of certain medical devices. Draft Resolution No 7091 proposes a revision of Resolution RDC No 3, dated 4 February…
On 24 October 2019, 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: 0521. These standards are intended to help…
Comments were accepted until 31 October 2019 on the draft guidance entitled, Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment1-3. The purpose of this draft guidance is to set out the Food and Drug Administration’s…
As part of its commitment to strengthening and modernising the 510(k) programme, the Food and Drug Administration (FDA) has issued four draft guidance documents1 and updated a final guidance document2 concerning the Safety and Performance Based Pathway. The four draft…
Guidance entitled Coronary, Peripheral, and Neurovascular Guidewires--Performance Tests and Recommended Labeling has been issued1,2 to update and clarify performance testing and labelling recommendations to support a pre-market notification (510(k)) submission for guidewires intended for use in the coronary vasculature, peripheral…
A Draft Commission Implementing Decision, which would update the Common Technical Specifications (CTSs) provided for in Article 5.3 of Directive 98/79/EC by amending Decision 2002/364/EC, has been circulated for public comment1,2. The proposal would update the CTSs for certain in…
A draft Commission Implementing Regulation setting out the rules for the application of Regulation (EU) 2017/745 with respect to the Common Specifications for the reprocessing of single-use medical devices has been released1. During the consultation period, which ended on 20…
In June 2019, the Therapeutic Goods Administration (TGA) released new guidance1 on the Therapeutic Goods (Conformity Assessment Standard for Quality Management Systems) Order 20192. The 2019 Order specifies relevant conformity assessment standards for medical device Quality Management Systems (QMSs), and…
In May 2019, ISO 20916:2019, In vitro diagnostic medical devices -- Clinical performance studies using specimens from human subjects -- Good study practice, was published1 by the International Organization for Standardization (ISO). This new, 56-page standard defines good study practice…
A draft first revision (1R) of Ecuadorian Technical Regulation PRTE INEN No 186, Electromedical equipment and systems, has been circulated for public comment1. The draft Ecuadorian Technical Regulation establishes revised requirements to be met by electromedical equipment and systems, prior…
Resolution of the Collegiate Board of Directors (RDC) No 291, dated 24 June 2019, provides for the use of parametric release and the use of biological indicators in place of the sterility test for new health products sterilised by ethylene…
On 17 July 2019, the Food and Drug Administration (FDA) updated its recognised consensus standards database1. New or revised recognised standards were added and standards that are no longer recognised were deleted. The Agency is permitted to determine which new…
Comments are being accepted until 13 August 2019 on a draft guidance document providing recommendations on the testing for interference by biotin on the performance of in vitro diagnostic devices (IVDs)1,2. The draft guidance is intended to help device developers…
Guidance has been drafted to outline recommendations for conducting mouse embryo assays (MEAs) to support pre-market submissions and lot release of assisted reproduction technology (ART) devices1,2. MEAs are used to assess the potential for embryotoxicity of ART devices that contact…
In an effort to align current Food and Drug Administration (FDA) regulatory requirements for laser product safety with international consensus standards, two new guidance documents have been released. Laser Products – Conformance with [International Electrotechnical Commission] IEC 60825-1 Ed. 3…
The Food and Drug Administration’s (FDA’s) policy on the regulation of medical x-ray imaging equipment, which is subject to the Federal Food, Drug and Cosmetic Act (FFD&C Act) and FDA’s regulations that apply to medical devices and electronic products, has…
Clarification of the Food and Drug Administration’s interpretation of certain aspects of the performance standard requirements for fluoroscopic equipment has been issued in the form of a final guidance document1,2. The performance standard requirements for fluoroscopic equipment are contained in…
Members of industry who submit, and Food and Drug Administration staff who review, information regarding orthopaedic devices using Ultrahigh Molecular Weight Polyethylene (UHMWPE) material have been provided with recommendations on the characterisation and testing of those devices1,2. UHMWPE materials include…
Guidance for industry and Food and Drug Administration staff entitled Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions has been developed to describe relevant information that manufacturers and third-party testing facilities (e.g. test laboratories) should include…
A final, leapfrog guidance has been published by the Food and Drug Administration to provide best practice recommendations for utilising animal studies to demonstrate that organ preservation devices are suitable for clinical use1,2. The Agency recommends balancing the ethical principles…
Introduction The final draft (FDIS) of the third edition of ISO 14155 is, at the time of writing, being prepared for circulation and ballot as ISO/FDIS 14155:2019. At this stage, only editorial changes are permitted, so the FDIS is likely…
In February 2019, the second editions of ISO 11607-1:2019, Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging systems1, and ISO 11607-2:2019, Packaging for terminally sterilized medical devices – Part 2: Validation…
On 26 March 2019, the following Draft Uganda Standards (DUSs) were formally adopted1: DUS 1958-1: 2018, Surgical sutures – Specification – Part 1: Absorbable; DUS 1958-2: 2018, Surgical sutures – Specification – Part 2: Non Absorbable; DUS 1959: 2018,…
Draft Uganda Standard (DUS) 2140: 2019 explains how to use the ISO 7886 and ISO 7864 standards for hypodermic syringes and hypodermic needles, respectively1. The draft standard outlines sampling and acceptance criteria for ISO 7886 for hypodermic syringes and ISO…
General and specific requirements, packaging rules, labelling criteria, sampling and methods of testing that apply to medical ultrasound gel are set out in a new Draft Uganda Standard (DUS)1. Comments on DUS 2129:2019 are being accepted until 7 June 2019…
A new Draft Uganda Standard (DUS) has been developed for umbilical cord clamps1. DUS 2111: 2018, Umbilical cord clamp – specification, sets out the requirements, test methods and sampling for umbilical cord clamps. It does not, however, include specifications for…
A number of new guidance documents pertaining to medical devices have been published1 by the Saudi Food and Drug Authority: MDS-G35, Guidance to Implement a Medical Devices Standard ‘Quality Management System’ Regulatory Requirement (ISO 13485:2016) (15 April 2019); MDS-G34,…
Two sets of amendments have been proposed to the Regulations on standard specification of medical devices. The first establishes new standard specifications for 135 Class I medical devices (e.g. endotherapy needle, general purpose, reusable)1. The second creates new standard specifications for…
A new mandatory Mexican Official Standard on excimer laser ophthalmic surgery practices has been drafted1. PROY-NOM-029-SSA3-2018, Regulation of health services – Practice of excimer laser ophthalmic surgery, applies to all medical healthcare facilities in the public, social and private sectors…
A second revision of Technical Regulation (PRTE INEN) No 049, Natural rubber latex male condoms, has been drafted and circulated for comment by the Ecuadorian Standardization Institute1. This revised standard establishes the requirements that must be met by natural rubber…
Controls have been introduced for the manufacture and/or import of sunglasses into Argentina, as well as for sunglasses destined for international trade1. Sunglasses are defined as glasses and filters of zero rated power (i.e. non-prescription) that protect against solar radiation.…
On 14 March 2019, 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: 0511. These standards are intended to help…
A draft guidance document entitled Technical Considerations for Non-Clinical Assessment of Medical Devices Containing Nitinol has been published1,2 to set out proposed recommendations for what manufacturers should include in their pre-market submissions for devices containing nitinol (an alloy of nickel…
