August Newsletter

August Newsletter

EU REGULATIONS

Guidance for notified bodies, distributors and importers on certification activities in accordance with Article 16(4) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 | 20 August 2021

This guidance is intended to aid notified bodies to implement requirements established by MDR and IVDR about certification activities to be carried out according to Article 16(4), attesting that the quality management system of the distributor or importer carrying out any of the activities mentioned in points (a) and (b) of Article 16(2) complies with the relevant requirements. This guidance is also addressed to distributors and importers in respect to their quality management system to be certified by a notified body.

Clarification on “first certification for that type of device” and corresponding procedures to be followed by notified bodies, in context of the consultation of the expert panel referred to in Article 48(6) of Regulation (EU) 2017/746 | 18 August 2021

This guidance provides clarification on the meaning of the below mentioned conditions and on the corresponding procedures to be followed by the notified body. For class D devices, Article 48(6) of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (the IVDR) establishes the conditions to be applied by the notified body to determine whether it must consult the expert panel on the performance evaluation report of the manufacturer. The conditions are:

  • 1. The absence of common specifications for the class D device in question
  • 2. Where it is also the first certification for that type of device

Guidance on performance evaluation of SARS-CoV-2 in vitro diagnostic medical devices | 03 August 2021

This guidance document concerns performance evaluation of SARS-CoV-2 in vitro diagnostic medical devices (IVDs) in the context of conformity assessment under either Directive 98/79/EC or Regulation (EU) 2017/746. The content of this guidance document is envisaged to form the basis for common specifications to be adopted according to Article 9 of Regulation (EU) 2017/746 in the coming months. The content may be adapted to take account of changing circumstances and increasing scientific and technical knowledge, as the COVID-19 pandemic continues to evolve.

CROATIA

New Regulation on the Administrative Fee Tariff | 26 August 2021

The Agency for Medicinal Products and Medical Devices of Croatia (HALMED) informs applicants that the Regulation on the Administrative Fee Tariff, has been published in the Official Gazette No. 92/21. The new Regulation, which enters into force on 1 September 2021, abolishes the payment of administrative fees in procedures conducted by HALMED.

BELGIUM

End of submissions for initial CTR pilot files on 14 October 2021 | 05 August 2021

The pilot project for the new Clinical Trial Regulation (CTR) will end when the CTR Regulation enters into force. All initial dossiers under the CTR pilot procedure must be submitted by 14 October 2021. The submission of initial clinical trials under the CTR pilot procedure will still be possible until Thursday 14 October 2021. This allows all initial dossiers to be closed before the regulation comes into force on 31 January 2022. Substantial changes following the pilot procedure will continue to be accepted until the end of the trial or until the transition from the trial to the regulation (which must be made no later than three years after implementation of the CTR).

Updated guidance for submission of clinical trial applications, substantial amendment notifications and end of trial declarations to the FAMHP | 05 August 2021

A new version of the guidance is available, and it supersedes the former circular letter 575. The FAMHP provides more information on the different aspects of clinical trials. The present guidance refers to clinical trials as defined in article 2(a) of Directive 2001/20/EC and does not apply to the submission of clinical trial applications selected for the CTR pilot project.

FINLAND

Laws supplementing EU regulations on medical devices come into force | 04 August 2021

The Acts supplementing the EU regulations on medical devices came into force on 19 July 2021. The Medical Devices Act 719/2021 and the Act on Certain Medical Devices Specified in EU Directives 629/2010 entered into force. In addition, technical amendments have been made to certain other Acts. The aim of the Acts is to improve the safety of patients and medical devices.

FRANCE

Certification of medical devices: GMED is designated as a notified body under the new European regulation | 20 August 2021

GMED, specialized in certification in the medical field, has been designated a notified body (ON) in France, under the new European regulation (EU 2017/745) on medical devices (MD). A notified body assesses and issues the CE marking necessary for the marketing of medical devices in Europe. This designation occurs at the end of the process required by the regulation to ensure the proper functioning of the notified bodies. This demanding process is essential for patient safety. 

The designation of GMED, which was published by the European Commission on 08/07/2020 on the NANDO Notified Bodies Database, will take effect on 09/07/2020, in accordance with Article 42 (11). From this date, GMED will be able to evaluate and certify MDs in accordance with the new European regulation.

ITALY

Medical devices, practical guide for the registration of actors in the European database EUDAMED | 19 August 2021

A short operational guide for voluntary registration in EUDAMED is available. The guide provides operational indications, presented in a simple and intuitive graphic format, intended for manufacturers, agents, importers and manufacturers of systems and procedural kits who want to voluntarily register in EUDAMED. For each phase of registration, the information required by the Ministry of Health for the verification and approval of registration requests is reported.

ECUADOR

Ecuador emerges as a cosmetic power in the international market | 23 August 2021

Entrepreneurs wishing to access the Mandatory Health Notification (NSO) of the National Agency for Regulation, Control and Health Surveillance (ARCSA) for the commercialization of cosmetics, will be able to apply their products to obtain this certification in 25 days. This initiative of the Government of the Meeting, in coordination with Procosmetics and with the aim of having “more Ecuador in the world”, will offer free of charge to microentrepreneurs and artisans of the cosmetic industry, the advice and endorsement of a technical representative with whom they must count for their certification. In this way, they will be able to obtain their NSO nimbly and market their products locally and internationally.

UK 

Register medical devices to place on the market | 24 August 2021 

A pre-existing guidance updated with links of video tutorials and a reference guide for Certificates of Free Sales

Clinical trials applications for Coronavirus (COVID-19) | 03 August 2021 

The National Institute for Health Research (NIHR) are no longer accepting applications for studies to be designated as Urgent Public Health (UPH). However, the MHRA, continues to support COVID-19 trials with ongoing regulatory and scientific input. The MHRA has procedures for rapid scientific advice, reviews and approvals and is supporting manufacturers, researchers, and other regulators.

USA

Medical Device Development Tools (MDDT) | 24 August 2021

The FDA’s Medical Device Development Tools (MDDT) program is intended to facilitate device development and timely evaluation of medical devices, and promote innovation, by providing a more efficient and predictable means for collecting the necessary information to support regulatory submissions and associated decision-making. 

510(k) Third Party Performance Metrics and Accreditation Status | 18 August 2021

The Accredited Persons Program was created by the FDA Modernization Act of 1997 (FDAMA) to improve the efficiency and timeliness of the FDA’s 510(k) process. Under the program, the FDA accredits third parties (or accredited persons, now known as third party review organizations) that are authorized to conduct the primary review of 510(k)s for eligible devices. Under MDUFA IV, the FDA committed to publishing the performance of individual accredited Third Parties with at least five completed submissions on this page (for example, rate of not substantially equivalent (NSE), average number of holds, average time to substantially equivalent (SE)). 

Medical Device User Fee Amendments (MDUFA) | 06 August 2021 

USER FY2021 – Annual Establishment FEES FOR Registration Fee: $5,546 

Other fees for Fiscal Year 2021 (October 1, 2020, through September 30, 2021) are:

APPLICATION TYPESTANDARD FEESMALL BUSINESS FEE (only CDRH Certified small businesses)
510(k) [All types of 510(k)s (Traditional, Abbreviated, and Special) are subject to the user fee. However, there is no user fee for 510(k)s submitted to the FDA on behalf of an FDA-accredited third-party reviewer]$12,432$3,108
513(g)$4,936$2,468
PMA, PDP, PMR, BLA$365,657$91,414
De Novo Classification Request$109,697$27,424
Panel-track Supplement$274,243$68,561
180-Day Supplement$54,849$13,712
Real-Time Supplement$25,596$6,399
BLA Efficacy Supplement$365,657$91,414
30-Day Notice$5,851$2,926
Annual Fee for Periodic Reporting on a Class III device (PMAs, PDPs, and PMRs)$12,798$3,200



Medical Device User Fee Amendments (MDUFA)

USER FEES FOR FY2022 – Annual Establishment Registration Fee: $5,672 

Other fees for Fiscal Year 2022 (October 1, 2021, through September 30, 2022) are:

APPLICATION TYPESTANDARD FEESMALL BUSINESS FEE (only CDRH Certified small businesses)
510(k) [All types of 510(k)s (Traditional, Abbreviated, and Special) are subject to the user fee. However, there is no user fee for 510(k)s submitted to the FDA on behalf of an FDA-accredited third-party reviewer]$12,745$3,186
513(g)$5,061$2,530
PMA, PDP, PMR, BLA$374,858$93,714
De Novo Classification Request$112,457$28,114
Panel-track Supplement$281,143$70,286
180-Day Supplement$56,229$14,057
Real-Time Supplement$26,240$6,560
BLA Efficacy Supplement$374,858$93,714
30-Day Notice$5,998$2,999
Annual Fee for Periodic Reporting on a Class III device (PMAs, PDPs, and PMRs)$13,120$3,280

All establishments must pay the establishment registration fee. There are no waivers or reductions for small establishments, businesses, or groups.

Accreditation Scheme for Conformity Assessment (ASCA) | 05 August2021

The ASCA Pilot is an accreditation scheme that capitalizes upon the increasingly prominent role that standards play in regulatory science and practice. The voluntary ASCA Pilot is intended to enhance product reviewers’ and device manufacturers’ confidence in medical device testing, which should decrease the need for the FDA to request additional information regarding testing methodologies when a premarket submission includes ASCA Pilot testing. Ultimately, the ASCA Pilot is intended to help the FDA ensure patients have timely and continued access to safe, effective, and high-quality medical devices.

Draft Guidance on Remanufacturing of Medical Devices | 05 August2021

The Food and Drug Administration (FDA or Agency) is extending the comment period for the notice of availability that appeared in the Federal Register of June 24, 2021. In the notice of availability, FDA requested comments on draft guidance for industry and FDA staff entitled “Remanufacturing of Medical Devices.” The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments. 

Medical Device Recall Authority |05 August 2021

Section 518(e) of the FD&C Act provides FDA with the authority to issue an order requiring an appropriate person, including manufacturers, importers, distributors, and retailers of a device, if FDA finds that there is reasonable probability that the device intended for human use would cause serious, adverse health consequences or death, to:

  • 1. Immediately cease distribution of such device and
  • 2. Immediately notify health professionals and device-user facilities of the order and to instruct such professionals and facilities to cease use of such device.

FDA will then provide the person named in the cease distribution and notification order with the opportunity for an informal hearing on whether the order should be amended to require a mandatory recall of the device. If, after providing the opportunity for an informal hearing, FDA determines that such an order is necessary, the Agency may amend the order to require a mandatory recall.

CANADA

Regulatory requirements for UV light-emitting products with COVID-19 claims |05 August 2021

UV light-emitting products make various claims related to decontamination and are sold and represented using terms such as disinfection, sterilization, sanitization, decontamination, and cleaning. Decontamination products using UVC that fall under MDD’s scope include those intended for sterilization or high-level disinfection of reusable medical devices used for critical or semi-critical purposes (for example, invasive procedures and personal protective equipment) within a controlled space. These sterilizers and high-level disinfectants are Class II medical devices including Therapeutic devices using UVA/UVB to treat skin conditions. They are used to mitigate or prevent infectious disease in humans and must not deteriorate the performance of the medical device.

Manufacturers of UVC decontamination devices must demonstrate high-level disinfection or sterilization of bacterial spores with an organism that offers a maximum challenge for the chosen technology. A high level of disinfection or sterilization is generally considered to be a minimum 6 log reduction (99.9999%). UV light-emitting decontamination products intended for use in rooms, on environmental surfaces or household products are not considered medical devices. 

AUSTRALIA

Medical devices reforms: Personalized medical devices | 23 August 2021 

A new framework has been introduced to ensure an appropriate level of regulation is applied to Personalised Medical Devices to manage the risk these devices may pose. Prior to 25 February 2021, most Personalised Medical Devices (PMD) met the definition of ‘custom-made’ and were exempt from the requirement to be approved by the TGA and included in the Australian Register of Therapeutic Goods (ARTG) before they could be imported, exported or supplied (though they were subject to other regulatory obligations). Following extensive consultation and liaison with other global regulators, the Therapeutic Goods Administration (TGA) developed a new regulatory framework for PMD to ensure an appropriate level of regulation is applied to PMD to manage the risk they may pose. The new framework came into effect on 25 February 2021, and includes: 

• new definitions for personalised medical devices, including patient-matched and adaptable medical
devices, that reduce the scope of the custom-made medical device exemption
• changes to the conditions of exemption for custom-made medical devices
• new requirements for the inclusion of Medical Device Production System (MDPS) in the ARTG

Regulation of software based medical devices | 19 August 2021

The TGA has implemented reforms to the regulation of software-based medical devices, including software that functions as a medical device. The guidance provides a summary of changes to the regulation of software based medical devices (including software as a medical device – SaMD) which came into effect from 25 February 2021. It outlines transition arrangements available for devices that may need to be reclassified. 

Medical device patient information leaflets and implant cards | 13 August 2021 

The guidance refers to requirements set out in clause 13A of Schedule 1 of the Therapeutic Goods (Medical Devices) Regulations 2002 (the MD Regulations) and provides an overview of:
• the different types of patient information materials (patient information leaflets and patient
implant cards)
• when patient information must be supplied
• how to meet the mandatory requirements for patient information
• best practice requirements for patient information.

Re-classification of software based medical devices | 12 August 2021

All new applications for inclusion of software based medical devices in the Australian Register of Therapeutic Goods (ARTG) must meet these new classification rules. For software that is already on the ARTG, there is a transition period. To access the transition period, you need to notify the TGA before 25 August 2021. The guidance below provides information about the new classification rules for software based medical
devices that:
• provide a diagnosis or screen for a disease or condition
• monitor the state or progression of a disease or condition, or the parameters of a person with a
disease or condition
• specify or recommend a treatment or intervention
• provide therapy through the provision of information

RUSSIA

Applicants submitting documents within the framework of medical device registration procedures | 23 August 2021 

The Federal Service for Supervision in the Field of Healthcare informs about the frequent cases of submission to Roszdravnadzor of documents for registration of medical devices, including amendments to documents contained in the registration dossier, of inadequate quality, including unreadable documents (both in terms of print and font size) and documents containing illegal corrections.

SWITZERLAND

Overview of the obligations of Swiss authorized representatives, importers and distributors | 13 August 2021

The Medical Devices Ordinance (MedDO; SR 812.213) sets out requirements and responsibilities for operators in the medical devices supply chain. The Information sheet outlines the roles and obligations of the Swiss authorized representative, the importer, and the distributor.

BRAZIL

ANVISA simplifies labeling change for sanitizing products | 19 August 2021

Brazilian Health Regulatory Agency (ANVISA) simplified the post-regularization procedure related to the change in labeling in sanitizing products, in accordance with the conditions established in Resolution of the Collegiate Board (RDC) 492/2021. The change implies the automatic approval of layout and label dimensions and inclusion of promotional sayings.

TANZANIA

TMDA ISO 9001:2015 Re-certified | 04 August 2021

TMDA (Tanzania Medicines & Medical Devices Authority) has been re-certified to ISO 9001:2015 standard after being subjected to a comprehensive external quality audit and found to comply with requirements. The ISO 9001:2015 certification will be valid for the next three years from July 2021 depending on successful compliance with annual surveillance audits.

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