The Medical Device Authority has officially recognised1 the Institute for Medical Research (IMR) as one of the institutions or laboratories capable of conducting, and reporting on, clinical evidence or performance evaluation for conformity assessment by a Conformity Assessment Body (CAB)…
Updated guidance has been published that outlines the categories of changes, the principles of change categorisation, and what should be done by the registration holder to ensure all regulatory requirements are met in order to continue the importation, exportation or…
The Medical Device Authority of Malaysia will enforce fully the medical device registration requirements set out in Section 5 of Act 737 from 1 January 20181. From this date, any establishment that intends to import, export and/or place medical devices…
A revision has been proposed to part 6 of the Israeli Mandatory Standard SI 1268, which concerns the colour coding for identification of single-use hypodermic needles1. The draft standard revision adopts the international standard ISO 6009: 2016, Hypodermic needles for…
With effect from 16 August 2017, the National Pharmaceuticals Pricing Authority has fixed the ceiling prices of orthopaedic knee implants used in India1. The price fixing Order stated ‘unjustified, unreasonable and irrational high trade margins leading to...exorbitant prices’ as a…
A period of public consultation has been held on the Essential Principles for the safety and performance of medical devices that have been drafted1 to support the Medical Devices Rules, 2017, which are due to come into force on 1…
On 28 September 2017, the China Food and Drug Administration published1 the following medical device industry standards with an implementation date of 1 October 2018: YY/T 0661-2017, Surgical implants – Semi-crystalline polylactide polymers and copolymer resins; YY/T 1141-2017, General requirements…
Interested parties have until 24 November 2017 to comment on three draft policies that have been issued by the China Food and Drug Administration to encourage and support the innovation of new medical devices and pharmaceuticals: Related Policies about Encouraging…
On 9 October 2017, the China Food and Drug Administration published five technical review guidelines for registration1: Guiding principles for the technical examination of the registration of enzyme/enzyme-labelled analysers/instruments; Guidelines for the technical examination of the registration of single-use electrocardiogram…
On 4 September 2017, the China Food and Drug Administration (CFDA) held a press conference to formally release the newly-revised Medical Devices Classification Catalogue, which will come into force on 1 August 20181. It is expected that the new Catalogue…
A revised version of the guidance to applicants on preparing for a pre-submission meeting with the Therapeutic Goods Administration (TGA) has been published1. This guidance applies to applications to enter therapeutic goods (including medical devices) on the Australian Register of…
Following a consultation held earlier this year1, a new regulatory framework for surgical mesh devices and provision of information to consumers for all implantable medical devices has been approved by the Australian Minister for Health2. This action supports Recommendation 20…
A new Therapeutic Goods Order has been issued to clarify another product that would not fall within the scope of a medical device under the Therapeutic Goods Act 1989. According to Therapeutic Goods (Articles that are not Medical Devices) Order…
The second revision of the Ecuadorian Technical Regulation (RTE INEN) No 181, Respiratory protection equipment, has been issued pursuant to Resolution No 17 335 of 14 June 2017 of the Under-Secretariat for the Quality System of the Ministry of Industry and Productivity,…
From 1 January 2019, there will be a prohibition on the manufacture, importation and commercialisation, as well as the use by healthcare professionals, of mercury and amalgam alloy in its non-encapsulated form indicated for use in dentistry1. The registrations of…
A Draft Technical Resolution has been published to propose extending the validity period of medical device registration certificates in Brazil from five years to 10 years1. The Draft Technical Resolution applies to medical devices within the scope of ‘correlatos’ referenced…
Following amendments to Brazil’s rules for Good Manufacturing Practice (GMP) certification, certain international products will be able to benefit from risk assessments, including reviews of technical documentation, rather than on-site GMP inspections1. The changes to Resolution RDC No 39/2013, which…
Clarification has been provided1 on how the Food and Drug Administration (FDA) will now process requests for recognition of voluntary consensus standards following changes implemented by the 21st Century Cures Act. These changes include adding a 60-day timeframe for the…
The US Food and Drug Administration (FDA) has announced the addition, withdrawal, correction and revision of certain consensus standards that the Agency will recognise for use in pre-market reviews and other requirements for devices. On 21 August 2017, the FDA…
The Food and Drug Administration has launched a voluntary pilot programme entitled Premarket Approval Application Critical to Quality (PMA CtQ)1. This pilot programme began on 29 September 2017 and will end on 31 December 2018; due to resource constraints, it is limited to…
Comments have been sought on a draft guidance that, when finalised, will clarify the Food and Drug Administration’s (FDA’s) policy on compliance with applicable performance standards and conformance to International Electrotechnical Commission (IEC) consensus standards for ultrasonic diathermy devices1,2. In…
Guidance has been drafted1,2 to assist industry in understanding when a microneedling product is a medical device as defined in section 201(h) the Federal Food, Drug and Cosmetic Act. ‘Microneedling products’ is a generic term that encompasses instruments with common…
Interested parties have until 14 November 2017 to provide comments on a draft leapfrog guidance for industry and Food and Drug Administration staff entitled, Utilizing Animal Studies to Evaluate Organ Preservation Devices1,2. The purpose of this draft guidance is to…
Comments are being solicited until 2 January 2018 on a draft guidance entitled Marketing Clearance of Diagnostic Ultrasound Systems and Transducers; Draft Guidance for Industry and Food and Drug Administration Staff1,2. When finalised, the guidance will provide detailed recommendations for…
Final guidance has been published by the Food and Drug Administration (FDA) entitled, Evaluation and Reporting of Age, Race, and Ethnicity Data in Medical Device Clinical Studies1,2. The purpose of this document is to summarise the Agency’s recommendations and expectations…
Recommendations have been issued in the form of a guidance document1,2 to facilitate study designs to establish the performance characteristics of in vitro diagnostic devices (IVDs) intended for the detection, or detection and differentiation, of human papillomaviruses (HPVs). These devices…
New guidance has been issued1,2 by the Food and Drug Administration (FDA) to explain the Agency’s current thinking on approaches for classifying products as drugs and devices, and on certain additional product classification issues. This guidance combines and finalises two…
On 6 September 2017, final guidance was issued by the Food and Drug Administration (FDA) entitled, Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices1-3. The purpose of this guidance is to assist industry and FDA staff in identifying…
New guidance from the Food and Drug Administration (FDA) clarifies how the Agency evaluates real-world data to determine whether it may be sufficiently relevant and reliable to generate the types of real-world evidence that can be used in FDA regulatory…
A new guidance document entitled Display Devices for Diagnostic Radiology1,2 provides recommendations on the type of information that should be included in a pre-market notification (510(k)) submission for display devices intended for diagnostic radiology with the assigned product code PGY.…
On 10 August 2017, a final version of the guidance document entitled Qualification of Medical Device Development Tools (MDDT) was released1,2. This guidance formalises the MDDT programme and provides guidance to Food and Drug Administration staff, industry, healthcare providers, researchers,…
The Food and Drug Administration’s (FDA’s) voluntary Software Precertification Pilot Program began on 1 September 20171. The purpose of this Program is to evaluate a new approach towards software products, including a pre-certification programme for the assessment of companies that perform high-quality…
In order to provide a reasonable assurance of safety and effectiveness for the assayed quality control material for clinical microbiology assays, they have been classified into Class II (special controls)1. The classification has been codified by the addition of §866.3920…
The balloon aortic valvuloplasty catheter has been classified into Class II (special controls)1 and the classification has been codified by the addition of §870.1255 to Title 21 of the Code of Federal Regulations. A balloon aortic valvuloplasty catheter is a…
A classification of Class II (special controls) has been deemed appropriate by the Food and Drug Administration (FDA) for the adjunctive cardiovascular status indicator in order to provide a reasonable assurance of the device’s safety and effectiveness1. An adjunctive cardiovascular…
The Food and Drug Administration has classified the device to detect and measure non-microbial analyte(s) in human clinical specimens to aid in assessment of patients with suspected sepsis into Class II (special controls)1. Section 866.3215 of Title 21 of the…
The Class II classification1 of the mass spectrometer system for clinical use for the identification of microorganisms has been codified at 21 CFR 866.3361. A mass spectrometer system for clinical use for the identification of microorganisms is a qualitative in…
The zinc transporter 8 autoantibody immunological test system has been classified into Class II (special controls)1. The special controls that apply to this device type form part of the codified language for the device’s classification at Title 21 of the…
The oral removable palatal space occupying device for weight management and/or weight loss has been classified into Class II (special controls)1. The special controls that apply to the device are described below and form part of the codified language for…
Upon request, the Food and Drug Administration has classified the automated image assessment system for microbial colonies on solid culture media as Class II (special controls)1 and codified the classification by the addition of Title 21 of the Code of…
The Food and Drug Administration (FDA) has classified the nucleic acid-based device for the amplification, detection and identification of microbial pathogens directly from whole blood specimens into Class II (special controls)1. The special controls that apply to the device type…
The enzyme packed cartridge has been classified into Class II and the special controls that apply to this device type form part of the codified language for its classification (21 CFR 876.5985)1. An enzyme packed cartridge is an ex vivo…
The Food and Drug Administration (FDA) has determined that the organophosphate test system can be classified into Class II with the establishment of special controls1, as special controls, in addition to general controls, will provide a reasonable assurance of the…
Following a de novo classification request, the Food and Drug Administration (FDA) has determined that a device to detect and identify microbial pathogen nucleic acids in cerebrospinal fluid can be classified into Class II with the establishment of special controls1.…
The Food and Drug Administration (FDA) has classified1 the cranial motion measurement device into Class II (special controls), and codified the classification by the addition of §882.1630 to Title 21 of the Code of Federal Regulations. A cranial motion measurement…
The closed loop hysteroscopic insufflator with cutter-coagulator has been classified into Class II (special controls) by the addition of §884.1710 to Title 21 of the Code of Federal Regulations1. Any company submitting a pre-market notification (510(k)) for such a device…
Following a de novo classification request, the high intensity ultrasound system for prostate tissue ablation has been classified into Class II (special controls) and the classification has been codified by the addition of §876.4340 to Title 21 of the Code…
On 18 August 2017, President Trump signed HR 2430, the FDA Reauthorization Act of 2017 (FDARA), which became Public Law No 115-521. Principally, FDARA re-authorises the Food and Drug Administration’s (FDA’s) user fee programmes, including the Medical Device User Fee…
Interested parties have until 4 January 2018 to submit comments on Health Canada’s new fee proposal for pharmaceuticals and medical devices1. Canada’s medical device fees have not been updated since 2011, and those figures were based on 2007 costings. Although…
A guidance document entitled Human Factors and Usability Engineering – Guidance for Medical Devices Including Drug-device Combination Products1 has been published by the UK Medicines and Healthcare products Regulatory Agency (MHRA). The guidance applies to manufacturers and developers of all…
