The Saudi Food and Drug Administration has extended the deadline for registering Class I non-sterile, non-measuring devices (i.e. low-risk Class I devices) via the expedited pathway to 11 September 20181. This is to ensure that there will be no impact on healthcare…
A period of public consultation has been held on a new schedule of fees and charges from the Food and Drug Administration for licensing, registration, and other authorisations and regulatory services1,2. The proposed fees that relate specifically to medical devices…
A policy for handling and controlling orphaned, obsolete and discontinued medical devices has been published by the Medical Device Authority via Circular No 2 of 20181. For the purposes of this policy, an orphaned medical device is an existing device…
A Circular has been published1 that outlines the policy for the implementation and enforcement under the Medical Device Act 2012 (Act 737) of the recognition and listing of institutes or laboratories that are capable of carrying out and providing data…
The Medical Device Authority has set out its policy for implementation and enforcement of an exemption from registration for export-only medical devices1. An export-only medical device is exempt from the medical device registration requirements under Section 5 of Act 737…
Malaysia began full enforcement of its medical device registration requirements, as set out under Section 5 of Act 737, on 1 July 20181. Medical devices that are not registered under this Act may no longer be imported, exported or placed…
Korea’s Ministry of Science and ICT (MSIT) has launched a Smart Healthcare Cybersecurity Guide to help ensure cyber safety in the medical sector1. The Guide provides advice to medical device developers and healthcare personnel responsible for managing cybersecurity on building…
On 2 July 2018, a guideline was published by the Ministry of Food and Drug Safety to define and classify criteria for medical devices, including in vitro diagnostic software, which use advanced technologies such as virtual reality or augmented reality1.…
The Ministry of Food and Drug Safety has proposed amendments to the Medical Device Act Enforcement Regulation in relation to adverse event reporting1. The proposed changes would clarify the scope of adverse events that should be reported to the Minister…
On 14 June 2018, the Medical Device Information and Technology Assistance Centre (MDITAC) changed its name to the National Institute of Medical Device Safety Information (NIDS)1. The role and responsibilities of the organisation remain unchanged. Reference http://www.nids.or.kr/
Five medical device-related Kenyan Standards (KSs) have been circulated for comment and are scheduled for adoption on 1 September 2018: KS 2551:2018, Sphygmomanometers, mercurial – Specification1; KS 2552:2018, Mouth props and airways (London Hospital Pattern) – Specification2; KS 2553:2018, Anaesthetic…
At its 79th meeting on 16 May 2018, the Drugs Technical Advisory Board (DTAB) considered a number of proposed amendments1 to the Medical Devices Rules, 2017, including an expansion of the list of notified medical devices. Details of the Board’s…
The effective date for the implementation of IS/ISO 15197: 2013 has been confirmed as 18 October 20191. The Indian Standard (IS) adopting ISO 15197:2013, In vitro diagnostic test systems – Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus, was…
Draft guidelines on the Essential Principles for safety and performance of medical devices under the provisions of the Medical Devices Rules, 2017 have been published1. The Essential Principles are grouped into those applicable to all categories of medical devices, those…
GN-07, Guidance Notes for Listing of Importers of Medical Devices1, has been fully revised by the Medical Device Control Office (MDCO). Corresponding changes have also been made to COP-04, Code of Practice for Listed Importers of Medical Devices, and Form…
Egypt’s Central Administration of Pharmaceutical Affairs (CAPA) has announced that all companies are required to register all medical devices and their accessories from 1 September 20181. Companies are obliged to request an appointment from the Medical Supplies Unit (Medical Devices…
A Technical guide for electronic submission of medical device registration applications (for trial implementation) has been drafted and circulated for comment1. The purpose of this draft guide is to instruct an applicant on how to use the new electronic Regulated…
Towards the end of June 2018, a draft Amendment of the Medical Device Supervision and Administration Regulations was circulated for public comment1. These proposed changes are quite extensive: 12 articles are proposed for addition, two for deletion and 39 for…
Comments have been solicited by the China Food and Drug Administration on proposals to simplify the renewal process for medical devices and to relax certain requirements concerning clinical trial applications1. Under the proposals, a Product Analysis Report would no longer…
Guidance entitled Regulatory requirements for in-house IVDs [in vitro diagnostics] has been updated1 to remove the transition information (which ceased to apply on 1 July 2017), to make minor textual changes, and to include more information about what constitutes an…
Following responses received during a public consultation, the Therapeutic Goods Administration (TGA) has decided to seek further stakeholder input on areas that were identified as requiring additional clarity before it implements any regulatory changes to personalised and 3D printed medical…
On 29 June 2018, the Therapeutic Goods Advertising Code 2018 was published in Australia’s Federal Register of Legislation1. It will take effect on 1 January 2019 and on this same date the 2015 Code will be repealed. The primary changes…
On 1 July 2018, an application fee of Aus$530 was introduced for a Class I medical device entry on the Australian Register of Therapeutic Goods (ARTG)1. To help sponsors optimise their ARTG listings so that they only pay fees where…
On 1 July 2018, revised fees and charges for medical device and in vitro diagnostic activities became applicable in Australia for the 2018–2019 financial year. Full details are available on the Therapeutic Goods Administration website1. Reference https://www.tga.gov.au/schedule-fees-and-charges
Mexico’s Federal Commission for the Protection against Sanitary Risk (COFEPRIS) has issued new guidelines relating to digital advertising campaigns (e.g. website banners, videos, social media posts) for medical devices and other healthcare products1. The guidelines cover both proprietary digital content…
The National Health Surveillance Agency (ANVISA) intends to publish proposed changes1 to Normative Instruction IN 03/20152 on the grouping of in vitro diagnostic medical devices (IVDs) for the purposes of product registration. IN 03/2015 regulates Resolution RDC No 36/20153, which…
In order to expedite the importation of health products into Brazil, new rules have been published that create four different import channels that take into account a product’s type and its associated risk criteria1. The green channel is a simplified…
Manufacturers of self-test instruments for glucose monitoring and any associated consumables must adhere1 to the requirements of ISO 15197: 2013, In vitro diagnostic test systems – Requirements for blood glucose monitoring systems for self-testing in managing diabetes mellitus2, when registering,…
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…
A public consultation has been held on a proposal to replace Brazil’s cadastro registration system with a notification system for low-risk Class I devices1. The consultation document sets out the requirements for a notification system and defines product notification as…
On 7 June 2018, the US Food and Drug Administration (FDA) published a significant update to its list of recognised consensus standards entitled Modifications to the List of Recognized Standards, Recognition List Number: 0491. These standards are intended to help…
An ‘innovation challenge’ has been launched1 by the Food and Drug Administration to provide additional incentives for medical device developers to invest in products that can provide novel solutions to detecting, treating and preventing opioid addiction, addressing diversion of prescription…
On 9 May 2018, the US federal government published its spring 2018 Unified Agenda of Federal Regulatory and Deregulatory Actions1, which provides federal agencies with the opportunity to update the public on the government’s regulatory priorities. One of the identified…
Guidance has been drafted for industry and Food and Drug Administration (FDA) staff on the current review practices for the Humanitarian Device Exemption (HDE) programme1,2. The draft guidance answers common questions about the HDE programme and responds to a requirement…
Interested parties have until 14 August 2018 to submit feedback on two draft guidance documents that provide industry and Agency staff with recommendations on the least burdensome means of assessing the performance of catheters, guidewires and delivery systems submitted in…
A period of public consultation has been held on a draft guidance document entitled Multiple Function Device Products: Policy and Considerations1,2, which sets out the Food and Drug Administration’s (FDA’s) regulatory approach for products with multiple functions, including at least…
In an effort to ensure that the non-clinical bench performance testing information provided in a pre-market submission is clear and consistent, guidance has been drafted to describe the recommended content and format of complete test reports1,2. [Pre-market submissions are Pre-Market…
Comments are being accepted until 17 September 2018 on a draft guidance entitled Metal Expandable Biliary Stents – Premarket Notification (510(k)) Submissions1. This draft guidance provides updated recommendations for manufacturers on the information and testing that should be included in…
Comments are being accepted until 6 August 2018 on a draft guidance document entitled, Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program1,2. Once finalised, this guidance will explain the ways submitters can request feedback from, or…
On 15 June 2018, the Food and Drug Administration (FDA) published a final version of its guidance on the Logical Observation Identifiers Names and Codes [LOINC] for In Vitro Diagnostic [IVD] Test1. This guidance addresses regulatory-specific questions about the distribution…
New guidance has been published for manufacturers, packers and distributors of medical products, including medical devices, on how the Food and Drug Administration (FDA) evaluates their medical product communications that present information that is not contained in the FDA-required labelling…
In accordance with the statutory mandate of the 21st Century Cures Act, the Food and Drug Administration has published a proposed list of processes for single-entity and co-packaged combination products that can satisfy the current Good Manufacturing Practice (cGMP) requirements…
The reclassification of post-amendment Class III medical image analysers applied to mammography breast cancer, ultrasound breast lesions, radiograph lung nodules, and radiograph dental caries detection into Class II (special controls), subject to pre-market notification, has been proposed1 by the Food…
A public consultation, which ended on 16 July 2018, gave interested parties the opportunity to comment1,2 on proposals to amend the regulations relating to the classification of products as biological products, devices, drugs or combination products, and their assignment to…
With effect from 17 May 2018, certain subtypes of surgical apparel have become exempt from the pre-market notification (510(k)) requirements, subject to conditions and limitations1. The exemption applies to single-use, disposable respiratory protective devices used in a healthcare setting and…
Five types of Class II medical devices no longer require pre-market notification (a 510(k)), subject to the general limitations to the exemptions found in §§862.9–892.9 of Title 21 of the Code of Federal Regulations (21 CFR)1. These devices are as…
The Food and Drug Administration (FDA) has issued a final order1 to reclassify needle destruction devices from Class III to Class II subject to pre-market notification, to rename them ‘sharps needle destruction devices’, and to establish special controls by revising…
Blood establishment computer software (BECS) and BECS accessories have been classified1 into Class II (special controls) as special controls, together with the general controls, should provide a reasonable assurance of the safety and effectiveness of these devices. BECS and BECS accessories…
Following a review of a de novo classification request, the Food and Drug Administration has classified the microneedling device for aesthetic use into Class II (special controls)1. The special controls that apply to the device form part of the codified…
Following a review of a de novo classification request, the Food and Drug Administration has classified1 the in vivo cured intramedullary fixation rod as Class II (special controls) and codified the classification at §888.3023 of Title 21 of the Code…
