Guidance has been drafted1 to clarify the requirements for medical device listing and for obtaining a Medical Devices Marketing Authorization (MDMA) for the purpose of importing, placing on the market and/or putting into service in Saudi Arabia. The draft guidance…
New guidance has been developed to assist in the notification of export-only medical devices, including in vitro diagnostic medical devices1. The importation, exportation, or placement of a medical device in the Malaysian market requires the medical device to be registered…
The post-market responsibilities of manufacturers and Authorised Representatives who have ceased trading after placing medical devices on the market in Malaysia have been set out in a new policy document1. If an Authorised Representative closes its business after placing a…
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)…
A new Law on In Vitro Diagnostic Medical Devices (IVDs) has been published in the Republic of Korea with an implementation date of 1 May 20201. This law defines the necessary matters for the handling, management and support of IVDs…
Officials have confirmed that the Ministry of Health, Labour and Welfare is considering establishing a rapid access mechanism for innovative/breakthrough medical devices, whilst still ensuring patient safety, along the lines of the Sakigake system used for certain drugs1. An innovative…
A Notice has been issued1 to announce that the classification of newly-notified medical devices is to be updated with a classification list of medical devices and in vitro diagnostics (IVDs) (see Table 1). Table 1. Classification list for newly-notified…
From 1 September 2019, the Center for Medical Device Evaluation (CMDE) will trial performing an initial acceptance review of submitted application materials in accordance with specified criteria1. This acceptance review process will judge the integrity, compliance, completeness and consistency of…
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…
On 4 July 2019, the National Medical Products Administration published Customized Medical Device Supervision and Management Regulations (Trial) (No 53 of 2019)1,2, which are set for implementation on 1 January 2020. The aims of these Regulations are to standardise the…
On 5 May 2019, the Medical Device Manufacturing Enterprise Supervision Information Platform was put into trial operation1. Initially, 17 provinces will test the platform, and the 14 provinces that already have similar systems will perform data docking test operations. Once…
China has implemented a system for the electronic application of medical device registrations using the electronic Regulated Product Submission (eRPS)1,2. Initially, the scope of application of the eRPS system is for medical devices registered by the National Medical Products Administration,…
The Therapeutic Goods Administration (TGA) has released a guidance document for industry on medical device cybersecurity1 to help manufacturers and sponsors understand how the TGA interprets the regulations, and thus indicate how to comply. The recommendations contained in the cybersecurity…
Sponsors will no longer receive reminders from the Therapeutic Goods Administration (TGA) about the need to submit annual reports1. All sponsors of Class IIb (implantable) devices, Class III devices, active implantable medical devices, and Class 4 in vitro diagnostics must…
In June 2019, the Therapeutic Goods Administration (TGA) released new guidance1 on the Therapeutic Goods (Conformity Assessment Standard for Quality Management Systems) Order 20192. The 2019 Order specifies relevant conformity assessment standards for medical device Quality Management Systems (QMSs), and…
On 1 July 2019, revised fees and charges for medical device and in vitro diagnostic activities became applicable in Australia for the 2019–2020 financial year. Full details are available on the Therapeutic Goods Administration website1. Reference 1. https://www.tga.gov.au/schedule-fees-and-charges
In May 2019, ISO 20916:2019, In vitro diagnostic medical devices -- Clinical performance studies using specimens from human subjects -- Good study practice, was published1 by the International Organization for Standardization (ISO). This new, 56-page standard defines good study practice…
Comments are being accepted until 10 September 2019 on a proposed update to the document from the International Medical Device Regulators Forum (IMDRF) outlining harmonised terminologies for reporting adverse events related to medical devices, including in vitro diagnostics (IVDs)1. Widespread…
Interested parties had until 24 July 2019 to comment on a proposed document issued by the International Medical Device Regulators Forum (IMDRF) entitled Personalized Medical Devices – Regulatory Pathways1. The purpose of this guidance document is to recommend a harmonised…
Standardised formats for notifying the Ministry of Health about suspected adverse incidents involving medical devices have been approved through publication of Directorial Resolution No 101-2019-DIGEMID-DG-MINSA on 14 June 20191. Two notification formats have been established: one for reports submitted by…
A mandatory Mexican Official Standard PROY-NOM-241-SSA1-2018, Good Manufacturing Practices for medical devices, has been drafted and circulated for comment1. The purpose of the standard is to set out the minimum requirements for the design, development, manufacture, warehousing and distribution processes…
A draft first revision (1R) of Ecuadorian Technical Regulation PRTE INEN No 186, Electromedical equipment and systems, has been circulated for public comment1. The draft Ecuadorian Technical Regulation establishes revised requirements to be met by electromedical equipment and systems, prior…
Resolution of the Collegiate Board of Directors (RDC) No 291, dated 24 June 2019, provides for the use of parametric release and the use of biological indicators in place of the sterility test for new health products sterilised by ethylene…
On 17 July 2019, the Food and Drug Administration (FDA) updated its recognised consensus standards database1. New or revised recognised standards were added and standards that are no longer recognised were deleted. The Agency is permitted to determine which new…
On 30 May 2019, the Illinois General Assembly passed Senate Bills 1854 and 1852 addressing sources of ethylene oxide emissions. Governor Pritzker signed these two bills into law, as Public Act 101-00221 and Public Act 101-00232 respectively, on 21 June…
Comments are being accepted until 13 August 2019 on a draft guidance document providing recommendations on the testing for interference by biotin on the performance of in vitro diagnostic devices (IVDs)1,2. The draft guidance is intended to help device developers…
Guidance has been drafted to outline recommendations for conducting mouse embryo assays (MEAs) to support pre-market submissions and lot release of assisted reproduction technology (ART) devices1,2. MEAs are used to assess the potential for embryotoxicity of ART devices that contact…
New draft guidance1,2 sets out recommendations for complying with the clinical testing special control under Title 21 of the Code of Federal Regulations (21 CFR) Part 876.4340(b)(8) for pre-market notifications (510(k)s) for high intensity ultrasound systems for prostate tissue ablation.…
In an effort to align current Food and Drug Administration (FDA) regulatory requirements for laser product safety with international consensus standards, two new guidance documents have been released. Laser Products – Conformance with [International Electrotechnical Commission] IEC 60825-1 Ed. 3…
New guidance1,2 has been published to clarify how applicants of combination products (drug, device, biologic) can comply with the 2016 final rule on post-market safety reporting requirements (PMSR) for combination products. Although the PMSR regulations for drugs, devices and biological…
New guidance has been published1,2 setting out recommendations for manufacturers seeking marketing clearance of diagnostic ultrasound systems and transducers. In addition to outlining regulatory approaches for certain diagnostic ultrasound devices, the guidance describes the types of modifications to a diagnostic…
The Food and Drug Administration’s (FDA’s) policy on the regulation of medical x-ray imaging equipment, which is subject to the Federal Food, Drug and Cosmetic Act (FFD&C Act) and FDA’s regulations that apply to medical devices and electronic products, has…
Clarification of the Food and Drug Administration’s interpretation of certain aspects of the performance standard requirements for fluoroscopic equipment has been issued in the form of a final guidance document1,2. The performance standard requirements for fluoroscopic equipment are contained in…
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…
Members of industry who submit, and Food and Drug Administration staff who review, information regarding orthopaedic devices using Ultrahigh Molecular Weight Polyethylene (UHMWPE) material have been provided with recommendations on the characterisation and testing of those devices1,2. UHMWPE materials include…
Guidance for industry and Food and Drug Administration staff entitled Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions has been developed to describe relevant information that manufacturers and third-party testing facilities (e.g. test laboratories) should include…
New guidance1,2 provides Institutional Review Boards (IRBs), industry, clinical investigators, and Food and Drug Administration (FDA) staff with factors to consider when evaluating the appropriateness of a live case presentation within a clinical investigation conducted under an Investigational Device Exemption…
Final guidance has been published entitled Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program1,2. This guidance clarifies the available ways submitters can request feedback from, or a meeting with, the Food and Drug Administration regarding potential…
A final, leapfrog guidance has been published by the Food and Drug Administration to provide best practice recommendations for utilising animal studies to demonstrate that organ preservation devices are suitable for clinical use1,2. The Agency recommends balancing the ethical principles…
A final rule has been issued1 to amend the Food and Drug Administration’s (FDA’s) regulations on the internal agency supervisory review of certain decisions relating to medical devices regulated by the Center for Devices and Radiological Health (CDRH) under the…
Guidance has been published to assist manufacturers and regulatory representatives in preparing medical device licence applications for 3D printed medical devices1. The guidance outlines the specific evidence required to support pre-market Class III and Class IV licence applications for implantable…
A revised version of the guidance entitled Management of Applications for Medical Device Licences has been issued by Health Canada1. The updated text is in line with Health Canada’s Good Guidance Practices and includes the following main changes: removal…
Health Canada has published a guidance document on the pre-market requirements for medical device cybersecurity in an effort to better protect patient safety1. The new requirements in the guidance, which came into force immediately, describe how and when to implement…
Regulations have been proposed1 to modify the Medical Devices Regulations and the Food and Drug Regulations in order to operationalise provisions from the 2014 Protecting Canadians from Unsafe Drugs Act, as well as to add certain post-market surveillance provisions for…
The Medical Devices Regulations are to be amended with effect from 16 December 2019 to specify certain medical device incident reporting requirements for hospitals1. The amendment adds the following text to the Regulations after section 61.1: ‘62 (1) For…
Canada’s 2017 budget granted the Minister of Health new fee setting authorities that give the flexibility to set and adjust fees in a timely way so that they better reflect actual costs and allow Health Canada to deliver more effectively…
Switzerland is soliciting comments on a complete draft revision of its Medical Device Ordinance (Medizinprodukteverordnung, MepV)1 and a draft new Ordinance on clinical trials for medical devices (Verordnung über klinische Versuche mit Medizinprodukten, KlinV-Mep)2. These documents are proposed for adoption…
Administrative responsibility for the product regulation of electromedical equipment has been transferred from the Directorate for Civil Protection and Emergency Planning (Direktoratet for samfunnssikkerhet og beredskap) to the Norwegian Medicines Agency (Statens legemiddelverk)1. As a result, the Agency is now…
The Netherlands has amended its Medical Devices Act to implement the European Regulation on medical devices (2017/745) and the Regulation on in vitro diagnostics (2017/746). The Act is currently in the Senate for approval1: the proposal was adopted by the…
Germany’s Federal Cabinet has passed a draft law for the introduction of a German implant registry (Gesetz zur Errichtung eines Implantateregisters Deutschland, EIRD)1, which will have its ongoing operation funded by fees. In order to ensure the completeness and usefulness…
