Stakeholders are being asked for their input on the feasibility of introducing a globally-harmonised Unique Device Identification (UDI) system in Australia, including options for the development of a UDI database (AusUDID)1. Any such UDI system would capitalise on the work…
An immediately-in-effect guidance document has been published on Unique Device Identification [UDI]: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking1,2. This document includes updated guidance on UDI direct mark requirements, and supersedes…
A period of public consultation has been held on a proposal to end the temporary extension to the grace period for submitting Device Identifier records to the Global Unique Device Identification Database (GUDID)1. In June 2014, the Food and Drug…
The compliance date for Global Unique Device Identification Database (GUDID) submission requirements of device constituents of co-packaged combination products assigned to the Center for Drug Evaluation and Research (CDER) for pre-market review has been extended by one year to 24 September…
Five new, non-binding guidance documents concerning Unique Device Identification (UDI) have been adopted by the Medical Device Coordination Group (MDCG) in accordance with Regulation (EU) 745/2017 (the Medical Device Regulation, MDR) and published on the European Commission website1: MDCG 2018-3,…
Consultations are underway on three documents drafted by the International Medical Device Regulators Forum (IMDRF)1: IMDRF Terminologies for Categorized Adverse Event Reporting (AER): terms, terminology structure and codes (consultation closes 12 October 2018) A proposed third edition of document N43,…
Linear or two-dimensional barcodes are to be added to the labels of coronary artery stents, drug-eluting coronary artery stents, and implants for hip and knee arthroplasty, according to Resolution RDC No 232 of 21 June 20181. These barcodes should follow…
Amendments have been proposed to the Law on Preparation and Implementation of Technical Legislation on Products, No 4703 of 2001, concerning the registration, traceability and follow-up of medical devices marketed in Turkey1. The draft Regulation (to amend the Law) requires…
The Taiwan Food and Drug Administration (TFDA) has completed a period of consultation on a new draft Medical Devices Act, which will formalise the separation of medical device legislation from that for drugs, i.e. the Pharmaceutical Affairs Act. It is…
The Republic of Korea has released additional information on the implementation of Unique Device Identification (UDI) as required by a regulation issued in December 20161. Korea is in the process of finalising its UDI code structure but it is anticipated…
The Food and Drug Administration (FDA) plans to extend the compliance dates1 for the Unique Device Identification (UDI) system requirements for certain Class I and unclassified devices, such as manual surgical instruments and mechanical wheelchairs. In order to extend the…
The Ministry of Health, Welfare and Sport has come to a voluntary agreement with the medical device industry, hospitals and other healthcare organisations to implement a Unique Device Identification (UDI) system for medical devices1 along the lines of that implemented…
Towards the end of 2017, the Ministry of Food and Drug Safety (MFDS) in the Republic of Korea issued a number of proposed regulatory amendments for public comment; details are as follows: Proposed amendments to the Regulations on Approval, Notification…
Consultation has been held on a Draft Resolution for the mandatory inclusion of Unique Device Identification (UDI)/International Medical Device Regulators Forum (IMDRF) standard barcodes on traceability tags for cardiac stents, and hip and knee implants1. It is hoped that the…
A guidance document entitled Unique Device Identification: Direct Marking of Devices1,2 has been issued by the Food and Drug Administration in order to clarify when direct marking of devices with a unique device identifier (UDI) is required, and to assist…
A new, immediately-in-effect guidance document1,2 sets out the Food and Drug Administration’s policy regarding Unique Device Identification (UDI) compliance dates for Class I and unclassified medical devices. UDI requirements are being phased in over seven years according to a schedule…
Brazil is a large country with extensive and constantly expanding medical device regulations. This report explores the changes that are likely to have the greatest impact on companies’ regulatory strategies during 2018. Firstly, it sets out the official regulatory agenda…
Interested parties have until 8 June 2018 to submit comments on China’s Medical Device Unique Identification System Rules (Exposure Draft)1. These draft rules specify the content of a Unique Device Identification (UDI) system for medical devices sold and used in…
