On 9 July 2024, Regulation (EU) 2024/1860 was published in the Official Journal1 to implement a gradual rollout of the EUDAMED database, introduce an obligation to inform in case of interruption or discontinuation of supply, and set new transitional provisions…
Medical Device Coordination Group (MDCG) 2024-1-5, Guidance on the vigilance system for CE-marked devices – Device Specific Vigilance Guidance (DSVG) 05, Urogynaecological Surgical Mesh Implants used for Pelvic Organ Prolapse Repair and Stress Urinary Incontinence, was published in June 20241. This…
The Ministry of the Environment has announced that the implementation of producer responsibility for packaging will be postponed from 1 July 2025 to 1 October 20251. This delay will give municipalities and manufacturers more time to adapt to the new…
The State Institute for Drug Control’s Medical Device Regulation Section has published Methodological Recommendations for the Implementation of IVDR [In Vitro Diagnostics Regulation] Requirements for In Vitro Diagnostic Medical Devices Manufactured and Used Only Within a Healthcare Facility1 (i.e. in-house…
Health Canada, the US Food and Drug Administration (FDA) and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) have jointly identified several guiding principles for transparency for machine learning-enabled medical devices (MLMDs)1. These principles build upon the guiding principles…
Health Canada has sought comments on proposed amendments1 to the Food and Drug Regulations and the Medical Devices Regulations that would help address and mitigate the harm to public health caused by shortages. Specifically, they would help prevent shortages of…
Amendments have been made to the Food and Drug Regulations and the Medical Devices Regulations (MDR) to establish clear obligations for industry when conducting recalls of therapeutic products and to strengthen Health Canada’s oversight of these recalls1. All amendments to…
Disposition No. 5634/2024 sets out the new annual fees for the maintenance of a registration in the Register of Medical Technology Producers and Products for both commercialised and non-commercialised products1 (see Table AR1). These fees are approximately three and a…
The Therapeutic Goods Legislation Amendment (2024 Measures No. 2) Regulations 2024 was registered on 14 June 20241,2. Changes to the exemption for certain prescription spectacle lenses, and to the classification rules for programmed or programmable medical devices or software that…
Version 3.0 of the guidance on the regulatory requirements for in-house in vitro diagnostic medical devices (IVDs) was published by the Therapeutic Goods Administration on 1 May 20241. This guidance is intended to support Australian laboratories that manufacture in-house IVDs…
New guidance has been released by the Therapeutic Goods Administration to assist sponsors, manufacturers, and software developers in understanding the boundaries between software that is and is not regulated1. The guidance examines each software exclusion in the Therapeutic Goods (Excluded…
The user guide1 for the Clinical Trial Notification (CTN) form has been updated (version 1.4, May 2024) to reflect recent updates to the online CTN form that came into effect on 5 April 2024. The CTN form now includes new…
A period of public consultation1 is being held until 6 August 2024 to determine whether legislating some products, where possible to declare their regulatory category formally (e.g. medical device, not a medical device, or other therapeutic good), will provide additional…
In an effort to improve the management of medical device clinical trial institutions and standardise their supervision and inspection, the National Medical Products Administration (NMPA) has published Measures for the Supervision and Inspection of Medical Device Clinical Trial Institutions (Trial)1,…
The Announcement of the National Medical Products Administration on Standardising the Classification and Definition of Medical Device Products (No. 59 of 2024) was published on 11 May 2024 to revise and standardise the classification processes for medical devices, combination products and newly…
In May 2024, an updated version of the Classification Catalogue of In Vitro Diagnostic [IVD] Reagents was published1–3 and this version will become effective on 1 January 2025. The IVD reagents included in the Classification Catalogue refer to IVD reagents…
According to Announcement No. 30 of 2022, radiofrequency therapeutic devices and radiofrequency skin therapeutic devices that act on human skin and subcutaneous tissue, cause pathological/physiological changes in human tissues and cells, and are intended to be used to treat skin…
Administrative requirements for the temporary importation and use of medical devices by medical institutions to meet an urgent clinical need have been issued and implemented in China through publication of Announcement No. 97 of 20241. These requirements clarify the obligations…
Announcement No. 68 of 2024 of the National Medical Products Administration states that, from 1 June 2024, certain administrative documents relating to medical device registration will be issued electronically, to further improve the efficiency and convenience of the Government’s services1. These…
The following Guiding Principles have been issued by the Center for Medical Device Evaluation1: Guiding Principles for the Registration Review of Traditional Chinese Medicine Pulse Diagnosis Equipment Products (17 June 2024); Guiding Principles for the Registration Review of Medical…
A period of public consultation has been held on the following draft guidelines1 issued by the Center for Medical Device Evaluation: Key Points and Judgment Principles for the Inspection of Medical Device Clinical Trial Projects (Draft for Comments) (14…
A dynamic List of Mandatory Standards Applicable to Medical Device Products has been updated1 to clarify the mandatory national standards and mandatory industry standards applicable to specific types of medical devices for ease of use by applicants/registrants. The 2024 List…
The Egyptian Drug Authority (EDA) has set out1 the procedures to be followed in case of expiry of quality certificates for medical supplies and devices issued under the former European Directive 93/42/EEC on medical devices. In accordance with the implementation…
The Egyptian Drug Authority is holding a public consultation until 18 July 2024 on the draft regulatory guideline, Guideline for Preclinical Testing and Clinical Investigation for Medical Devices1, which is intended to provide guidance to those involved in designing pre-clinical…
On 18 July 2024, the Ethiopian Food and Drug Authority posted a new Medical Devices Adverse Event Reporting (MDAER) form on its website for use by healthcare professionals and users1. MDAER is one of the post-market surveillance tools used by…
On 5 June 2024, the Department of Health announced that it had established the Hong Kong Centre for Drugs and Medical Devices Preparatory Office1. The remit of this Preparatory Office is to put forward recommendations and steps for the formal…
Recently, 36 new medical device industry standards have been released and details are provided in Table CN11. In addition, the following two medical device industry standards have been amended2: YY 0167-2020, Non-absorbable Surgical Sutures, Medical Device Industry Standard No.…
A new electronic service platform – the Medical Device Information System (MDIS) – was launched in April 2024 to provide a one-stop service for industry to submit online applications for listing of medical devices and traders in accordance with the Medical…
The Department of Health is preparing to implement the second phase of new regulations on the procurement of medical equipment1; the first phase started on 21 June 2023. These strengthened measures will be implemented in two stages: Stage 1…
Guidance Document No. GN-01, Overview Guidelines for Medical Device Administrative Management Systems, was updated on 13 May 2024 (GN-01:2024-2(C)) with immediate effect1. This most recent version of GN-01 adds a new section 3.2.1.13. This section adds devices for non-clinical purposes…
As reported previously in the Journal, all non-notified Class C and D medical devices that were under mandatory registration moved to the licensing regime with effect from 1 October 20231 and now require a manufacturing/import licence to be placed on…
On 11 May 2024, the Ministry of Health issued Announcement Number FR.03.01/E/884/2024 concerning the application of Good Distribution Practices (Cara Distribusi Alat Kesehatan yang Baik, CDAKB) as a condition of obtaining a distribution permit1. Based on Minister of Health Regulation…
On 2 June 2024, the Medical Equipment Division launched a fast-track registration process for Class II medical devices and medium-risk in vitro diagnostics (IVDs)1. The instructions for submitting requests for fast-track registration (new/renewal/change) appear on the Ministry of Health website…
The Medical Equipment Division has published updated procedures for initial, renewal and change registration applications, including details of the required accompanying documents. These updated procedures will come into effect on 1 January 20251. For each of these procedures, new versions…
Comments are being sought1 on a revision of the Mandatory Standard SI 60601-1, Medical electrical equipment – Part 1: General requirements for basic safety and essential performance. This draft standard revision adopts the international standard IEC 60601-1:2005+A1:2012+A2:2020 (edition 3.2), with…
Circular Letter No. 1/2024 sets out the implementation and enforcement policy relating to medical devices that are imported from, or exported to, countries without diplomatic ties with Malaysia that are subjected to trade restrictions1. Although the Medical Device Act 2012…
On 5 June 2024, the Medical Device Authority (MDA) began issuing electronic establishment licences1. An establishment can download its establishment licence from the MeDC@St 2.0+ system once the application has been completed (status complete) and the licence fee payment has…
The Medical Device Authority has advised establishments to submit medical device re-registration applications via the MeDC@St 2.0+ system one year prior to the certificate expiration date to avoid any issues that might occur during the re-registration process1. According to the…
On 7 June 2024, the Medical Device Authority launched the first phase of a pilot survey to assess the readiness of medical device establishments in Malaysia to provide all the information required for the Unique Device Identification (UDI) of their…
The Government of New Zealand has announced that the Therapeutic Products Act will be repealed in 2024 so that a better regime can be put in place to provide New Zealanders with safe and timely access to medical devices, medicines…
Guidance has been provided on the streamlined registration process for next generation medical devices, which allows applicants to leverage data that has been submitted to the Health Sciences Authority for previously registered devices1. Medical devices often undergo numerous iterations to…
The Thai Food and Drug Administration (FDA) has introduced changes to simplify the registration process for medical devices in Thailand1. There are two registration pathways mentioned in the announcement: Full pathway, with three options for evaluating the quality, performance,…
The Medical Device Control Division of the Food and Drug Administration (FDA) has published information to help manufacturers decide if their software qualifies as a medical device1, to determine its risk classification2, and to specify the applicable product registration documents3.…
On 1 May 2024, the Thai Food and Drug Administration (FDA) announced that three documents would no longer need to be submitted as hard copies during regulatory transactions, to reduce the administrative burden on companies1. Registrants of health products contacting…
Guidelines have been drafted for referencing original documents or transferring documents or other cases in submitting an application for permission to manufacture or import and requesting to report details of production or import of medical devices1. The guidelines relate to…
The following technical documents have been issued1 recently by the International Medical Device Regulators Forum (IMDRF): IMDRF/RPS WG/N9 Final:2024 (Edition 4), Non-In Vitro Diagnostic Device Table of Contents (nIVD ToC) (25 June 2024); IMDRF/RPS WG/N13 Final:2024 (Edition 4), In…
Interested parties have until 30 August 2024 to submit comments on the International Medical Device Regulators Forum’s (IMDRF’s) proposed Good Machine Learning Practice for Medical Device Development – Guiding Principles (IMDRF/AIWG/N73 DRAFT: 2024)1. The following 10 proposed guiding principles are…
The new price list for services in the field of medicines and medical products performed by the Agency for Medicinal Products and Medical Devices of Croatia (HALMED) entered into force on 9 March 20241. The new fees apply to all…
On 13 March 2024, the European Parliament adopted1 the proposed text of the Artificial Intelligence Act (AI Act) in this latest stage of the legislative process. For the medical device industry, implementation of the AI Act could potentially impact the…
MDCG 2024-5, Guidance on Content of the Investigator’s Brochure for Clinical Investigations of Medical Devices, was published by the Medical Device Coordination Group (MDCG) on 17 April 20241. This guidance document is intended to assist sponsors in developing their Investigator’s…
