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 establishment of regulations for the medical device de novo classification process has been proposed by the Food and Drug Administration (FDA)1. Although the de novo process was added to the US statute in 1997 and has been recently modified…
The Food and Drug Administration has announced1 the withdrawal of two previously proposed rules because these proposed rules are not currently considered viable candidates for final action: Laser Products; Proposed Amendment to Performance Standard (FDA-2011-N-0070); Electronic Submission of Labeling…
Following a de novo classification request, the Food and Drug Administration has classified the meprobamate test system into Class II (special controls) subject to pre-market notification1. The classification has been codified by the addition of §862.3590 to Title 21 of…
High flow humidified oxygen delivery devices have been classified1 into Class II (21 CFR 868.5454) and are subject to pre-market notification requirements under section 510(k) of the Federal Food, Drug and Cosmetic Act. A high flow humidified oxygen delivery device…
Upon request, the Food and Drug Administration (FDA) has classified the active implantable bone conduction hearing system into Class II (special controls)1. The Agency believes this action will enhance patients’ access to beneficial innovation, in part by reducing regulatory burdens…
Following a review of information submitted in a de novo request, the Food and Drug Administration has determined that an insulin therapy adjustment device can be classified into Class II with the establishment of special controls (21 CFR 862.1358)1 as…
On 26 December 2018, the Food and Drug Administration (FDA) published a final order1 confirming the reclassification of certain electroconvulsive therapy (ECT) devices, and the effective date of a requirement for pre-market approval (a PMA) for ECT devices for certain…
A final rule entitled Medical Device Classification Procedures: Incorporating FDA Safety and Innovation Act Procedures will take effect on 18 March 20191. The purpose of this rule is to implement the applicable provisions of the Federal Food, Drug & Cosmetic…
Health Canada has published an Action Plan on Medical Devices that sets out a three-part strategy for improving the safety and effectiveness of medical devices in Canada and for optimising health outcomes for Canadian patients1. Health Canada hopes to achieve…
Comments were accepted until 8 January 2019 on a draft guidance document concerning the licensing requirements for implantable medical devices manufactured by 3D printing1. As with all Class III and IV medical devices, devices produced by additive manufacturing (or 3D printing)…
Stakeholder feedback has been sought on technical considerations for the cybersecurity of medical devices and the pre-market submission requirements for a medical device licence1. The draft guidance document provides device manufacturers with advice on the practices, responses and mitigation measures…
Health Canada has released a guidance document entitled Requirements in the Recognition Process for Medical Device Single Audit Program (MDSAP) Auditing Organizations, which took effect on 1 January 20191. This guidance document outlines for stakeholders the requirements that the Therapeutics Products…
Following a review of the 2000 Interim Policy on Priority Review of Medical Device Licence Application, Health Canada has concluded1 that the existing request process is unnecessarily complex, and that consideration should be given to unforeseen or unmet urgent health…
In order to enable Canada to conform to its international trade obligations under the Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP), regulatory amendments to the Medical Devices Regulations (MDR)1 and the Radiation Emitting Devices Regulations (REDR)2 were required. The…
Minor changes have been made to the recommendations on leadless cardiac pacemaker therapy published by the Medicines and Healthcare products Regulatory Agency’s Expert Advisory Group1. The changes reflect the clinical experience gained over the last year, including operator experience and…
As of 30 January 2019, we are not really any closer to knowing what will actually happen when the UK leaves the European Union (EU) on 29 March 2019. Despite Members of the UK Parliament saying they do not want…
The Spanish Agency for Medicines and Health Products (AEMPS) and the Spanish Society of Cardiology have launched an online platform called CardioDispositivos to maintain a national registry of pacemakers and implantable cardioverter defibrillators (ICDs)1. The registry records will be used…
Notifications of clinical investigations involving CE marked medical devices for approved indications with variations of the usual clinical practice may now be submitted electronically to the Spanish Agency of Medicines and Health Products (AEMPS)1. Applicants must first register with the…
On 2 December 2018, Serbia’s new Law on Medical Devices came into full effect1. At the same time it was announced that all the activities of the Agency for Medicinal Products and Medical Devices of Serbia in the field of…
Three new Ordinances pertaining to medical devices were published in the Official Gazette of the Republic of Serbia (No 84) on 2 November 2018: Ordinance on registration of a medical device1 This legislation sets out the conditions for, and…
A new version of the Manufacturer Incident Report (MIR) has been published on the European Commission’s website, along with a help document for completing the form correctly1. The new MIR is based on the common terminology developed by the International…
The European Commission has updated1 its manual on borderline and classification issues for medical devices to assist the national Competent Authorities in their decision-making processes. Version 1.20 of the manual includes the following new consensuses on borderline and classification issues: 25,…
The European Commission has published five additional documents to support the implementation of the Medical Device Regulation (EU) 2017/745 (MDR) and In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR): Factsheet for Authorities in non-EU/EEA States on Medical Devices and in vitro…
Interested parties had until 19 October 2018 to comment on the first edition of draft Uganda standard DUS 2011:2018, Sterile surgical blades – Specification1. This draft standard specifies the requirements, methods of testing and sampling methods for sterile surgical blades.…
Singapore’s Health Sciences Authority (HSA) intends to increase the fees it charges for health product regulatory activities, including medical devices, by an average of 3%1. The fee increases are set to take effect on 2 April 2019. The majority of…
On 18 September 2018, the Saudi Food and Drug Authority (SFDA) issued MDS-G29, Guidance for the Medical Devices Samples for Laboratory Testing, version 1.01. The purpose of this guidance is to clarify the procedure for laboratory testing of medical device…
A summary of classification decisions has been released for products at the medical device-drug-cosmetic interphase (MDDCI)1. For each product, the intended purpose/indication and mode of action is specified, along with the classification (e.g. medical device) and the relevant regulatory agency…
A Circular has been issued1 that sets out an updated policy for the implementation and enforcement under the Medical Device Act 2012 for medical devices imported from/exported to countries without diplomatic ties with Malaysia (e.g. Israel). This revised policy states…
A first revision of the formal policy on the implementation and enforcement of an exemption from registration for export only medical devices has been published1. Section 5(1) of the Medical Device Act 2012 (Act 737) states that no medical device shall…
The Medical Device Authority of Malaysia has extended the compliance deadline for medical device labelling requirements to 20211. Originally a two-year transition period had been provided for establishments to comply with the labelling requirements specified in the Sixth Schedule to…
An amendment has been proposed to the Standards of Medical Device Good Manufacturing Practices (GMP) in the Republic of Korea1. If finalised, the amendment would harmonise Korea’s requirements with international practices by adopting ISO 13485: 2016. It would improve the…
Public consultation has been held on a proposed revision1 to the mandatory Israeli Standard SI 1268 Part 3, Syringes and needles: Sterile hypodermic syringes for single use – Syringes for manual use. This draft revision adopts ISO 7886-1:2017, Sterile hypodermic…
A Guidance Document for Medical Devices has been drafted1 by the Indian Pharmacopoeia Commission (IPC) to act as a consolidated reference document describing the standards, regulatory and other requirements for medical devices in India. Topics addressed by the draft guidance…
An online classification programme for in vitro diagnostic medical devices (IVDs) has been launched1 by the Medical Device Control Office (MDCO) to help manufacturers accurately classify their devices according to the associated risk level. The programme does, however, include a…
The use of Egyptian Standard ES 1595-1, Rubber gloves for medical use – Part 1: Single-use sterile rubber surgical gloves – Specification, has become mandatory following the publication of Ministerial Decree No 477/20181. Producers and importers have been provided with…
Comments have been sought on a proposed Regulation for the Supervision and Administration of Chinese Agents of Imported Medical Devices1. The purpose of the Regulation is to strengthen the supervision and administration of imported medical devices, to regulate Chinese agents…
In order to reduce the regulatory burden on the Australian medical device industry, and to better align with other international regulators, instructions for use (IFU) for medical devices may now be provided electronically in certain circumstances, either online through a…
The Therapeutic Goods Administration is seeking feedback on a proposal1 for the specific regulation of in vitro diagnostic (IVD) companion diagnostics, as the current IVD regulatory framework does not ensure adequate evaluation of IVD companion diagnostics in conjunction with associated…
In September 2018, the Therapeutic Goods Administration introduced a new process for issuing Certificates of Free Sale and Export Certificates1. This process sets out the eligibility criteria for applying for a Certificate of Free Sale or an Export Certificate, what…
The Therapeutic Goods Administration (TGA) intends to expand the range of international assessments and approvals from comparable overseas regulators that sponsors may provide when submitting their applications for inclusion of medical devices in the Australian Register of Therapeutic Goods (ARTG)1.…
The Therapeutic Goods Administration (TGA) has clarified the updated requirements that an application for inclusion of a medical device in the Australian Register of Therapeutic Goods (ARTG) must meet in order to pass preliminary assessment1. These requirements are set out…
On 12 October 2018, the Therapeutic Goods Administration’s summary of fees and charges was updated to include a change in the application fee for export only medical devices1. The revised document states that the application fee for inclusion in the…
After consolidating the comments received from Asian Harmonization Working Party (AHWP) members, a final version of the guidance on Labelling for In Vitro Diagnostic Medical Devices (IVDs) (AHWP/WG2/WD001:2018)1 was proposed for adoption at the 23rd AHWP meeting in Malaysia in…
Amendments have been made1 to Annex No. 01 (Glossary of Terms and Definitions) of the Regulation for the Registration, Control and Sanitary Vigilance of Pharmaceutical Products, Medical Devices and Sanitary Products, approved by Supreme Decree No 016-2011-SA. One of the…
On 31 December 2018, natural rubber latex male condoms, male synthetic condoms and female condoms are expected1 to be incorporated into the health control system established in Article 111 of the Health Code, as approved by Ministry of Health Supreme…
The National Health Surveillance Agency (ANVISA) has clarified the procedure for dealing with cases of divergence between shelf-life information contained in the product registration and in the import process1. An example would be when the shelf-life specified in the medical…
Interested parties have until 12 November 2018 to submit comments to the National Agency of Sanitary Surveillance (ANVISA) on draft Resolution 546/2018, which establishes requirements for the manufacturing, marketing, import, export, and exposure to the use of custom-made and patient-specific…
On 22 October 2018, the US Food and Drug Administration (FDA) published another significant update to its list of recognised consensus standards entitled Modifications to the List of Recognized Standards, Recognition List Number: 0501. These standards are intended to help…
