The Medical Device Coordination Group intends to group highly individualised devices with clear clinical similarities under an identifier called the ‘Master UDI’ (Unique Device Identification)1. European Union rules provide for a UDI system to make the traceability of medical devices…
Manufacturers, companies, distributors, importers and warehouses dealing with all types of medical devices and laboratory reagents are required to apply1 international commodity barcodes (GTIN) to their medical devices that are traded in Egypt, as listed in the electronic MeDevice platform’s…
In December 2021, the Egyptian Drug Authority published guidance1 to define its requirements for Unique Device Identification (UDI) for medical devices, their accessories and in vitro diagnostics (IVDs) in accordance with the provisions of the Chairman’s Decision No. 499 of…
Implementation of Unique Device Identification (UDI) has been delayed from 1 January 2022 until further notice by a Notification published by the Ministry of Health and Family Welfare on 31 December 20211. According to Rule 46 of the Medical Devices Rules,…
A substantial revision of Section III of the guidance Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking (1 July 2020) has been proposed and comments on the changes are being…
The Food and Drug Administration (FDA) has extended two Unique Device Identifier (UDI) alternatives – UDI-A160001 and UDI-A160002 – until 24 September 20231. This extension means certain non-prescription, over-the-counter medical devices intended to be sold exclusively through retail establishments may…
Announcement No. 114 of 2021 specifies details of the second phase of Unique Device Identification (UDI) implementation in China1. The first phase started on 1 January 2021 and involved 69 Class III medical device types2. The second phase of implementation…
The Ministry of Food and Drug Safety of the Republic of Korea is proposing to amend1 the Placement and Management of Unique Device Identifiers on Medical Devices with respect to the requirement that licence holders who manufacture or import medical…
The dates for complying with Saudi Arabia’s Unique Device Identification (UDI) system for medical devices have been amended1. Entering information in the UDI database for Class D (high risk) medical devices has been postponed from 1 August 2021 to 1…
The Medical Devices Branch of Singapore’s Health Sciences Authority has released a guidance, dated August 2021, on the medical device Unique Device Identification (UDI) system1. This guidance is intended to clarify the regulatory requirements for UDI implementation in Singapore as…
Commission Implementing Decision (EU) 2021/1195 of 19 July 20211 includes references to four harmonised standards for in vitro diagnostic medical devices (IVDs) drafted in support of Regulation (EU) 2017/746 (the IVDR). The following harmonised standards satisfy the requirements which they…
Two changes have been made to the Medical Device Coordination Group (MDCG) guidance on basic Unique Device Identification-Device Identifiers (UDI-DIs) and changes to UDI-DIs (MDCG 2018-1)1. In the section entitled The Basic UDI-DI, the word ‘group’ has been deleted from…
A specific Unique Device Identification (UDI) assignment solution for contact lenses is under development by the Medical Device Coordination Group (MDCG) and may also be extended to spectacle frames. For spectacle lenses and ready readers, a specific UDI assignment solution…
The Medical Device Coordination Group (MDCG) has endorsed1 the principles set out in Appendix E to Appendix I of the International Medical Device Regulators Forum guidance document IMDRF/UDI WG/N48FINAL:2019, Unique Device Identification system (UDI system) Application Guide2. Through the publication of…
Guidance has been released1 to assist in the integration of Unique Device Identification (UDI) and the implementation of UDI obligations as part of an organisation’s Quality Management System (QMS), as required by Article 10(9)(h) of Regulation (EU) 2017/745 on medical…
The Medical Device Coordination Group (MDCG) has released six questions and answers on the European Medical Device Nomenclature (EMDN)1. This nomenclature has been created, inter alia, for use by manufacturers when registering their medical devices in the European database on…
The Food and Drug Administration (FDA) has announced, through publication of a guidance document1,2, that it does not intend to object to the use of legacy FDA identification numbers (i.e. National Health Related Item Code (NHRIC) or National Drug Code (NDC)…
Guidance for industry and Food and Drug Administration (FDA) staff entitled Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI) has been issued to help labellers and FDA-accredited issuing agencies to comply with the UDI labelling…
Comments are being accepted until 6 September 2021 on Draft Resolution No. 1051, which sets out a Unique Device Identification (UDI) system to enhance the identification of medical devices in Brazil and to facilitate their traceability1,2. This Draft Resolution applies…
In May 2021, the Agencia Nacional de Regulación, Control y Vigilancia Sanitaria (ARCSA) issued an External Instruction on the presentation of the gradual plan for the implementation of traceability of medicines, biological products and medical devices1. This Instruction indicates in…
The Medical Devices Branch of Singapore’s Health Sciences Authority has released a draft Guidance on the Medical Device Unique Device Identification (UDI) System for public comment1. This draft guidance is intended to clarify the regulatory requirements for Unique Device Identification…
New requirements for the creation and affixing of Unique Device Identification (UDI) information to medical devices to aid traceability throughout the supply chain come into force on 1 May 20211,2. The UDI requirements will be phased in gradually, starting with…
A period of public consultation has been held on a set of draft Requirements for the Single Identification Code to be Published on the Labels of Medical Devices1. These requirements apply to the creation and affixing of Unique Device Identification…
Starting in 2022, Singapore plans to introduce a Unique Device Identification (UDI) system1 that is aligned to the UDI system adopted by the International Medical Device Regulators Forum. Singapore also plans to recognise the following international organisations for the assignment…
A partial revision of the Regulation for Enforcement of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices will be adopted in February 2021 and will enter into force in August 20211. This revision…
On 21 December 2020, Premier Li Keqiang of the State Council agreed to pass the Regulations on the Supervision and Administration of Medical Devices (Revised Draft)1. The changes strengthen the responsibility of enterprises and research institutions to ensure the safety…
The Medical Device Coordination Group’s MDCG 2020-18 provides clarification on Unique Device Identification (UDI) assignment obligations for manufacturers of spectacle lenses and ready readers1. Article 10(7) of Regulation (EU) 2017/745 on medical devices (MDR) states that manufacturers must ‘comply with…
Australia is holding a consultation to explore the options for introducing a Unique Device Identification (UDI) system1. This consultation is seeking feedback on the following specific questions: What are the benefits of an Australian UDI system across the broader…
The first phase of implementation of China’s Unique Device Identification (UDI) system1,2 has been delayed from 1 October 2020 to 1 January 20213. Additionally, the scope of products covered by the first phase has been increased. The UDI pilot programme,…
As part of the implementation of Saudi Arabia’s Unique Device Identification (UDI) system for medical devices, the UDI database (Saudi-DI) has been launched1. Since 1 October 2020, data can be entered into the database on a voluntarily basis. However, entering…
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…
On 8 July 2020, a report1 of the Independent Medicines and Medical Devices Safety Review made numerous recommendations for improving patient safety in the UK. The report highlighted the need for substantial reform of the Medicines and Healthcare products Regulatory…
Updated guidance1,2 from the Food and Drug Administration describes the Agency’s plan for enforcement of the Unique Device Identification (UDI) requirements for Class I and unclassified devices. It also sets out the Agency’s direct mark compliance policy for Class III,…
Introduction The agency in charge of regulating medical devices in Argentina is the National Administration of Drugs, Food Products and Medical Technology (ANMAT). ANMAT Disposition No 1285/2004 (restatement of Disposition 2318/2002) defines a medical device as any equipment, device, material,…
Introduction With a huge population, growing economy, and healthcare aimed at covering 1.4 billion people, China has become the second largest medical device market in the world, averaging a 20% growth rate annually. In 2018, device sales in China reached…
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…
The following documents were endorsed as final during the 24th Asian Harmonization Working Party (AHWP) Annual Meeting in Muscat, Oman from 11–14 November 2019: Categorisation of Changes to a Registered Medical Device1 This document provides advice to regulatory authorities…
New rules for a unique identification system for medical devices have been published (No 66 of 2019) and were implemented officially on 1 October 20191,2. All medical devices sold and used within the People’s Republic of China must comply with these…
A question-and-answer document on the new European identification system for medical devices, which is based on a Unique Device Identifier (UDI), has been issued to provide additional guidance on the topic1. The European UDI system will facilitate easier traceability of…
Introduction The agency in charge of regulating medical devices in Argentina is the National Administration of Drugs, Food Products and Medical Technology (ANMAT). ANMAT Disposition No 1285/2004 defines a medical device as any equipment, device, material, product or system of…
A period of public consultation has been held on a regulation to establish and enact an Integrated Medical Device Information System (IMDIS)1. The regulation specifies the information that must be submitted to the new database, including Unique Device Identification (UDI)…
The National Medical Products Administration of China has announced a pilot work plan for a Unique Device Identification (UDI) system for medical devices1 to strengthen the management of medical devices throughout the total product lifecycle. In July 2019, the pilot…
Guidance has been published entitled Unique Device Identification [UDI]: Convenience Kits; Guidance for Industry and Food and Drug Administration Staff to clarify the Food and Drug Administration’s (FDA’s) interpretation of the rules regarding UDIs on convenience kits and medical procedure…
Market overview It is estimated that local manufacturers only meet 10% of the market demand for medical devices in Vietnam, while 90% of medical devices are imported, especially advanced technology like diagnostic imaging equipment. Local manufacturers have only been able…
A list of four issuing entities designated to operate a system for assignment of Unique Device Identifiers (UDIs) pursuant to Regulation (EU) 2017/745 on medical devices and a system for assignment of UDIs pursuant to Regulation (EU) 2017/746 on in…
According to an Interim Report1 on the work of the Executive Working Group dated 30 January 2019, the European Union (EU) and the USA will cooperate to ensure alignment of electronic database specifications for Unique Device Identifiers (UDIs) and will…
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,…
On 8 March 2019, the temporary extension to the Global Unique Device Identification Database (GUDID) grace period came to an end, and the grace period was returned to the original seven days1. According to the GUDID guidance document2, the GUDID Device…
Additional and updated guidance documents to support the implementation of Unique Device Identification (UDI) under Regulations (EU) 2017/745 and 2017/746 have been released by the Medical Device Coordination Group (MDCG): MDCG 2019-1, MDCG guiding principles for issuing entities rules…
Two new final guidance documents have been published1 by the Saudi Food and Drug Authority (SFDA): MDS-G20, Guidance on Requirements for Clinical Investigations of Medical Devices; and MDS-G30, Guidance on Patient-Matched Medical Devices Using 3D Printers. In addition, eight new draft…
