On 22 November 2023, the Australian Government released its 2023–2030 Australian Cyber Security Strategy1. This Strategy is the roadmap that will be used to help realise the Government’s vision of becoming a world leader in cybersecurity by 2030. Through the…
From 1 January 2024, any applicant that is deemed to be guilty of repetitive violations by the National Health Regulatory Authority (NHRA) will no longer be eligible1 for the exemptions for medical device importation provided for under Circular 23/2020. In…
Biodegradable, expanding haemostatic sponges are polyether-type polyurethane sponges that are composed of (DL-lactide-co-ε-caprolactone)-urethane copolymer and are disposable. Such products are sterilised by irradiation and are provided in a sterile state. They are used for temporary compression, haemostasis and support after…
Announcement No. 153 of December 20231 from the National Medical Products Administration concerned the publication of quality management standards for medical device operations (Good Manufacturing Practices, GMP). These standards will take effect on 1 July 2024 and, at that time,…
Good Online Supply Practices for Medical Devices have been drafted and circulated for public comment1. The purpose of this draft document is to strengthen the quality management of medical devices sold online, standardise the rules for medical device online distribution,…
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abolition of two medical device industry standards1: YY 0569-2011, Class II Biological Safety Cabinet, which will be repealed as of 1 November 2025; YY/T 0687-2008, Surgical instruments – Non-cutting articulated instruments…
From 1 January 2024, the Medical Device Division will accept1 a marketing approval issued by the Chinese National Medical Products Administration or the Ministry of Food and Drug Safety in the Republic of Korea to support compliance with the Basic…
A new guidance document – GN-10, Changes to Scheduled Medical Devices – has been published1 to help Local Responsible Persons in classifying, managing and reporting changes to scheduled medical devices, and explaining how to report relevant changes to the Medical…
A new Technical Reference document TR-008, Artificial Intelligence Medical Devices (AI-MD), was published on 3 January 2024 and took effect immediately1. Although the requirements for the safety, quality and performance of medical devices have already been established by the Essential…
The first edition of Technical Reference TR-007, Software Medical Devices and Cybersecurity, was issued on 29 December 2023 with immediate effect1. This document aims to provide an overview of, and definitions for, software developed for medical purposes, both software in…
Technical Reference TR-006, In vitro diagnostic medical device classification1, was revised in December 2023 in line with the International Medical Device Regulators Forum’s Principles of In Vitro Diagnostic (IVD) Medical Devices Classification (IMDRF/IVD WG/N64FINAL:2021). Amendments have been made to the following…
The classification lists for in vitro diagnostic medical devices (IVDs) under the provisions of sub-rule (2) of rule 4 of the Medical Devices Rules, 2017 have been updated and supplemented1. The classification list of IVD analysers has been updated and…
The National Single Window System (NSWS)1 has been established by the Central Government to act as a ‘one-stop shop’ for all approvals, licences, registrations and clearances that may be required to do business in India. The NSWS portal section created…
In light of the current situation in Israel as well as the validity extensions granted in Europe for regulatory approvals, a further administrative extension of validity will be granted to Medical Equipment Division approvals to ensure a continuous supply of…
In communications dated 27 November 20231,2, the Kenya Bureau of Standards confirmed that the following two East African Standards (EASs) have been adopted via Gazette Notice No. 13353 of 29 September 2023: EAS 1069:2021, Cotton ear bud – Specification, which…
Three new documents pertaining to Good Manufacturing Practices (GMP) for medical devices have been published by the Ministry of Food and Drug Safety: Medical Device Manufacturing and Quality Management (GMP) Review Casebook (Guide-1316-01)1, dated 15 November 2023, which introduces…
From 1 December 2023, all completed advertisement applications must be sent via email to advertisement@mda.gov.my1. Applications received in hard copy will no longer be processed. Applications must include all the requested information, and a completed checklist form to confirm all…
With effect from 1 October 2023, a Certificate of Free Sale (CFS) will only be issued for registered medical devices, so CFSs for export-only medical devices will no longer be issued1. CFSs for export-only medical devices that were issued before…
The second editions of MDA/GD/0062, Medical Device Guidance Document – Harmonised Classification of Medical Devices in ASEAN [Association of South East Asian Nations]1, and MDA/GD/0063, Medical Device Guidance Document – Harmonised Borderline Products in ASEAN2, were published in December 2023.…
In response to a Decision from the General Registration Technical Committee Meeting, the Medical Device Authority (MDA) has determined1 that, from 1 January 2024, only the recognised Quality Management System (QMS) standards stated in Table MY1 will be accepted for…
Interested parties have until 15 March 2024 to comment on a draft schedule of fees and charges for licensing, registration, and other authorisations and regulatory services performed by the Food and Drug Administration (FDA)1,2. The current fees and charges of…
A period of public consultation has been held on a draft Circular on the use of the Food and Drug Administration (FDA) eServices Portal System for the initial application of a Certificate of Medical Device Notification (CMDN)1. This draft Circular…
From 1 July 2024, a fee increase averaging 5% will be implemented by the Health Sciences Authority for medical devices and other therapeutic products1. This fee revision is necessary to recover part of the costs for the services rendered to…
On 20 November 2023, the Health Sciences Authority made changes to its document on Change Notification applications for changes to registered medical devices resulting from the European Union Regulations on medical devices and in vitro diagnostics (IVDs)1. This revised document…
A period of public consultation has been held on a revised draft of GN-20, Guidance on Clinical Evaluation1. The updates reflect the Health Sciences Authority’s position on the use of real-world data in medical device clinical evidence, as well as…
Following consultation with industry, the Cyber Security Agency of Singapore (CSA) has launched a nine-month trial1 for participating medical device manufacturers to test out and provide feedback on the requirements and application processes for the Cybersecurity Labelling Scheme for Medical…
In a communication dated 18 December 20231, it was confirmed that the final text of the amendments to the Regulations Governing Issuance of Medical Device License, Listing and Annual Declaration (April 2021) had been adopted, published and entered into force on…
On 5 January 2024, the Ministry of Public Health published an Announcement regarding the need to establish a quality system for importing or selling medical devices in Thailand1. This Announcement will become effective on 5 January 2025. According to this…
A period of public consultation has been held on a draft Announcement1 of the Ministry of Public Health regarding the production of medical devices exempted according to Section 27(8) of the Medical Device Act B.E. 2008. The production of medical…
A second revision of the Guide on the Implementation of the Medical Device Sales, Advertising and Promotion Regulation (TCS-KLVZ-08) was published in January 20241. Topics covered include: the application, authorisation certificate, employment certificate and identity card; education, examination, certificate…
Circular No. 20/2023/TT-BYT, which came into effect on 1 January 2024, has repealed a number of legal documents issued by the Minister of Health1. It has completely repealed the following five documents: Circular No. 30/2015/TT-BYT of 12 October 2015 regulating…
On 27 November 2023, the US Food and Drug Administration (FDA) sent a letter1 notifying the Global Harmonization Working Party (GHWP) of its decision to officially withdraw as a member of the GHWP, citing increasing concerns about divergent harmonisation efforts…
In November 2023, the Global Harmonization Working Party (GHWP) finalised and released the following guidance documents: GHWP/WG1-WG2-WG3/F002:2023, Principles of Regulatory Requirements for Electronic Instructions for Use (eIFU)1 GHWP/WG2/F001:2023, Guidance for Additional Considerations to Support Conformity Assessment of In vitro…
The 51-page standard ISO/IEC 42001:2023, Information technology – Artificial intelligence – Management system, was published in December 20231. ISO/IEC 42001 is an international standard that specifies requirements for establishing, implementing, maintaining, and continually improving an Artificial Intelligence Management System (AIMS)…
In the first quarter of 2024, the Medical Device Register (RZPRO) will be replaced fully by the Medical Device Information System (ISZP)1. This change will affect distributors, service providers and custom-made medical device manufacturers. Before the ISZP’s launch, information on…
The Ministry of the Environment has changed the timetable for the implementation of producer responsibility for packaging from 1 January 2025 to 1 July 20251. The start date for reporting the quantities of packaging that companies expect to market has…
Guidance has been published by the Medical Device Coordination Group on medical device software intended to work in combination with hardware or hardware components (MDCG 2023-4)1. Specifically, the guidance examines and provides clarifications on which regulatory considerations apply when the…
In September 2023, the third version of the Manual on borderline and classification for medical devices under Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices was published1. This document presents the borderline…
In September 2023, a question-and-answer document was published1 on the transitional provisions that apply to products without an intended medical purpose covered by Annex XVI to Regulation (EU) 2017/745 on medical devices (MDR). The purpose of this document is to…
On 20 October 2023, the European Commission published1 Commission Delegated Regulation (EU) 2023/2197 to amend Regulation (EU) 2017/745 on medical devices (MDR) with respect to the assignment of unique device identification device identifiers (UDI-DIs) for contact lenses. The published text…
Comments were accepted until 27 October 2023 on the proposed fees for 2024 for medical device related activities conducted by the Health Products Regulatory Authority (HPRA)1. A general fee increase of 1.5% has been proposed. It has also been proposed…
The State Institute for Drug Control (SUKL) has confirmed1 that manufacturers, Authorised Representatives, importers or distributors of medical devices or in vitro diagnostic medical devices (IVDs) who make a medical device or IVD available on the Slovak market according to…
The Federal Council has agreed to amend the Medical Devices Ordinance (MepV) to improve the safety of devices without an intended medical purpose1. Switzerland has adapted the MepV for these products in line with the European Union (EU) requirements, taking…
Comments are being accepted until 4 December 2023 on a proposed rule to improve the safety and effectiveness of laboratory developed tests (LDTs)1. LDTs are in vitro diagnostic medical devices (IVDs) that the Food and Drug Administration (FDA) has described…
Final guidance has been published on the Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process”1. This guidance replaces the 2000 guidance of the same name and…
Final guidance for industry and Food and Drug Administration (FDA) staff entitled Antimicrobial Susceptibility Test (AST) System Devices – Updating Breakpoints in Device Labeling has been released1,2 to provide information on updating susceptibility test interpretative criteria (STIC)/breakpoints and associated performance…
Technical Considerations for Medical Devices with Physiologic Closed-Loop Control Technology (PCLC) has been published to highlight the technical considerations for medical devices that use PCLC technology to ensure their safe and effective use1,2. The final guidance provides recommendations for the…
