On 10 October 2023, the Food and Drug Administration (FDA) published minor updates to the following magnetic resonance related guidance documents: Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices1; Testing and Labeling Medical Devices for Safety in the…
Guidance has been drafted on the Electronic Submission Template for Medical Device De Novo Requests1,2. This draft guidance clarifies the resources available to support the electronic submission of de novo requests to the Center for Devices and Radiological Health and…
A list of prioritised medical device guidance documents that the US Food and Drug Administration (FDA) plans to publish over the next 12 months has been posted on the website of the Center for Devices and Radiological Health (CDRH)1. A…
A new Digital Health Advisory Committee has been established1 within the Food and Drug Administration (FDA) to support the Agency in handling the complex, scientific and technical issues that relate to digital health technologies, such as artificial intelligence/machine learning, augmented…
Provision No. 8194/2023, which was published in the Official Gazette on 3 October 2023, sets out new requirements for Good Technovigilance Practices that will be mandatory for all registration holders of medical products authorised by the National Administration of Medicines,…
Draft Resolution 1208 of 16 October 20231 proposes changes to the administrative procedures for the granting of Good Manufacturing Practice (Boas Práticas de Fabricação, BPF) certification and certification of Good Distribution and Storage Practices, to allow for an increase in…
In an effort to streamline review processes, the Federal Commission for the Protection against Health Risks (COFEPRIS) has announced1 new ‘classification’ criteria for modifications to sanitary registrations of medical devices (Modificaciones a las Condiciones de Registro Sanitario, MCRS), which became…
On 16 October 2023, updated guidance was issued1 to address commonly asked questions on the off-label use of medical devices. ‘Off-label use’ means using a product for a reason that is not listed as one of the indications for use…
The Directorate General of Drug Administration under the Ministry of Health & Family Welfare has published the Drugs and Cosmetics Act, 20231, repealing the Drugs Act, 1940 and the Drugs (Control) Ordinance, 1982. Medical devices are included under the term…
The Egyptian Drug Authority has announced that, as of 2 January 2024, companies wishing to obtain import approvals for unregistered medical devices, including but not limited to Class I, non-sterile medical devices, must submit commitment letters from the applicant and…
The Egyptian Drug Authority has issued a note clarifying how the transition periods set out in European Regulation (EU) 2023/607 are to be implemented in Egypt1. Regulation (EU) 2023/607 amended Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU)…
As reported in our August 2023 issue, all non-notified Class C and Class 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…
Circular No. HK.02.02/E/1289/2023 sets out certain requirements relating to post-market testing of medical devices1. Distribution permit holders are expected to carry out post-market testing of products in circulation to ensure they continue to meet their safety, quality and benefit requirements.…
Laos’ Food and Drug Department of the Ministry of Health has published a new regulation on the registration and notification of medical devices (No. 1470), which entered into force on 9 September 20231. The new rules are largely aligned with the Association…
The third revision of GN-05: Guidance on the Reporting of Adverse Events for Medical Devices was released in September 20231. Like the guidances on complaint handling and good distribution practice mentioned in the previous article, a note has been added…
A second revision of the Medical Devices Product Classification Guide (GL-06)1 was released in October 2023. This guide has been produced by the Medical Devices Branch to assist stakeholders in determining whether a product is classified as a medical device. For…
The format of establishment registration certificates for medical device manufacturers and importers has been amended. The establishment registration certificate for medical device manufacturers will follow the format of the newly amended Form B.S.P.11, while the establishment registration certificate for medical…
To ensure the quality, safety and efficiency of medical device production, guidelines for implementing a quality system for medical device manufacturing have been drafted1. If finalised, the announcement of the guidelines will come into force 120 days after publication in…
In an effort to ensure the quality, safety and performance of medical devices throughout the supply chain, the Ministry of Public Health has drafted good practice criteria and procedures that will apply to Quality Management Systems for importing or selling…
Earlier this year, Circular No. 10/2023/TT-BYT1 was issued by the Ministry of Health to amend and supplement several articles of Circular No. 19/2021/TT-BYT to specify documents that must be included in submission dossiers and reports for implementation of Decree No.…
Interested parties have until 20 November 2023 to submit comments to the Global Harmonization Working Party (GHWP) Secretariat (secretariat@ghwp.info) on the following proposed guidance documents: Guidance Document on the Risk-Based Approach to Quality Management System Aspects: ISO 13485:20161 Guidance for…
In September 2023, the final version of Personalized Medical Devices – Regulatory Pathways1 was issued by the International Medical Device Regulators Forum (IMDRF). This guidance sets out recommendations for a harmonised approach to the application of existing regulatory pathways to…
Comments were accepted until 3 October 2023 on Working Group 9’s proposed document entitled GHWP [Global Harmonization Working Party] UDI [Unique Device Identification] Rule1. This document outlines a UDI system, which should include a UDI identifier, a UDI carrier, and…
A free, voluntary vigilance programme to support medical device sponsors in complying with their ongoing post-market surveillance responsibilities is being piloted for 12 months1. All Australian medical device sponsors who have an entry in the Australian Register of Therapeutic Goods…
The comment period has now closed on a consultation concerning how the Therapeutic Goods Administration (TGA) selects medical device applications for audit and how the TGA conducts these audits1. This consultation sought feedback on key elements of a proposed application…
All medical healthcare facilities must register with the National Health Regulatory Authority (NHRA) and obtain a permit to use medical devices and medical products, according to Circular No. (20) 20231. This registration must be completed by the end of 2025,…
In August 2023, amendments were made to 58 types of medical devices listed in the Medical Device Classification Catalogue1. Of note, ultrasonic cutting and haemostatic blades, ultrasonic soft tissue surgical blades, and ultrasonic suction surgical blades (01-01-03) have been up…
A summary of decisions on classification requests submitted by foreign and domestic manufacturers between January and April 2023 has been published by the Center for Medical Device Standardization Administration (see Table CN1)1. These classification decisions can help applicants determine the…
In an effort to standardise data inputs and thereby permit enhanced data sharing and collaboration for medical devices and in vitro diagnostic (IVD) reagents, basic data sets have been created to specify, for each unit of data, the definition, identification,…
The Catalogue of Medical Devices Exempted from Clinical Evaluation (2023) has been published and is in effect1. It is worthy of note that this catalogue is the first of its kind to refer to ‘clinical evaluation’ as opposed to ‘clinical…
Consultation has been held on draft Measures for the Review and Management of Advertisements for Drugs, Medical Devices, Health Foods, and Formula Foods for Special Medical Purposes1. These updated Measures have been proposed to strengthen the supervision and management of…
The following Guiding Principles and Key Points have been issued by the Center for Medical Device Evaluation1: Key Points for the Review of Artificial Intelligence Software Functions in Magnetic Resonance Imaging Systems (15 September 2023); Guiding Principles for the…
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 Review of Human Factors Design of Medical Devices (second consultation) (11 October…
A total of 45 medical device industry standards have been approved and published by the National Medical Products Administration1. Details of these standards are provided in Table CN2. CN2. Newly published medical device industry standards Standard number Standard name…
Seven medical device industry standard amendment orders have been approved and issued1. Details of these standards are provided in Table CN3. CN3. Medical device industry standard amendment orders Standard number Standard name Implementation details YY 0068.4-2009 Medical Endoscopy –…
Comments are being solicited on the following five draft medical device standards issued by the National Medical Products Administration: Medical glass thermometer1 This document specifies the requirements, test methods, inspection rules, marks, and operation instructions of medical glass thermometers.…
The E-Waste (Management) Rules, 2022 came into force on 1 April 2023 and apply to every manufacturer, producer, refurbisher, dismantler and recycler involved in the manufacture, sale, transfer, purchase, refurbishing, dismantling, recycling and processing of electronic waste or electrical and…
On 1 July 2023, India’s new rules on plastic waste management took full effect and these rules have an impact on the medical device industry1,2. The rules refer to Extended Producer Responsibility, which means the responsibility of a producer (manufacturer)…
On 14 August 2023, the Ministry of Health published a proposed outline of reforms designed to shorten dramatically the registration and importation times of medical devices and equipment1. Under the proposal, registration of all Class 1 medical devices would be…
A revision of the mandatory standard SI 60601-1, Medical electrical equipment – Part 1: General requirements for basic safety and essential performance, has been circulated for public comment1. This draft standard revision adopts the international standard IEC 60601-1 edition 3.2…
Comments are being sought on the draft Kenya Standard DKS 638:2023, Absorbent cotton gauze and gauze bandages – Specification (fourth edition)1. This draft standard specifies the requirements and test methods for bleached absorbent gauze and gauze bandages for use in…
Circular Letter Number 1/2023 has been published1 to set out the Medical Device Authority’s policy on permission for placement in the market of self-testing kits to detect human immunodeficiency virus (HIV) infection. To guarantee quality, HIV self-test kits that do…
Comments have been solicited on a draft guidance document entitled Importation of Medical Device for Re-Export (IRE)1. This guidance is intended to clarify the requirements and notification process for an applicant (e.g. an established company in Malaysia, licensed establishment or…
In August 2023, the Medical Device Authority (MDA) published a draft guidance document entitled Importation of Medical Device for Personal Use for public comment1. This document is intended to inform the public on the guidelines for bringing (importing) medical devices…
Public comment has been sought on a new draft guidance document entitled Wearable Medical Device1. The purpose of this guidance document is to set out the regulatory requirements that apply to wearable medical devices and to provide examples of wearable…
Singapore’s Health Sciences Authority (HSA) has revised several guidance documents and templates relating to medical device product registration. GN-15, Guidance on Medical Device Product Registration (revision 9)1, clarifies that the supply and use of any medical device in Singapore must…
A third revision of GN-14, Guidance on the Risk Classification of In Vitro Diagnostic Medical Devices, has been released1. In this version, a new definition of standalone software has been added: ‘software and/or mobile application that is intended to function…
A fifth revision of GN-02, Guidance on Licensing of Manufacturers, Importers and Wholesalers of Medical Devices, has been published1. This revision adds definitions for the Medical Device Single Audit Program (MDSAP) and for refurbishing, which means: ‘restoring used medical…
The fourth revision of GN-16, Guidance on Essential Principles for Safety and Performance of Medical Devices, makes a minor change to Annex 1, section 9 on clinical evaluations1. A note has been added stating that clinical investigations are generally expected…
A minor change has been made to medical device guidance GN-07, Guidance on Complaint Handling of Medical Devices (revision 3), dated September 20231. A note has been added to the scope to clarify that medical device dealers should encourage feedback…
