Medical Devices - Regulatory Updates - July Volume 1
Clinical trials with trial participants can be gradually (re)started
Due to the corona crisis the majority of the clinical trials conducted were put on hold. Since the Dutch Government currently gradually reduces the restrictive measures, there is room on the national level to gradually restart clinical trials that were put on hold or start new initiated clinical trials, not being clinical trials in CRUs. In order to be allowed to (re)start clinical trials, not being clinical trials in CRUs, requirements should be complied with. This document is restricted to clinical trials under the Medical Research Involving Human Subjects Act (WMO).
Communication concerning the return of deposits and the evaluation of advertising visas for pharmaceutical specialties, medical devices and in vitro diagnostic medical devices - Information Point
Regarding DM and DMDIV advertising visas
For DMs and DMDIVs whose advertising must be subject to a prior authorization request, the filing of these advertising requests can be made at any time during the year. The ANSM has a period of 2 months, from the date of receipt of the complete file, to authorize publicity or notify the applicant of a reasoned refusal. Beyond this period and without response from the ANSM, the request is deemed accepted.
For requests whose evaluation was to end during the legally protected period (from March 12 to June 23, 2020 inclusive), the evaluation period is suspended and resumes its course, for the remaining period, from 24 June 2020. The absence of an Agency decision at the end of this period will constitute implied authorization.
For requests whose evaluation was to start and expire during the legally protected period, the starting point of the evaluation period is postponed, for the initial period of 2 months, to June 24, 2020. These requests will be deemed to have been accepted in no decision as of August 24, 2020.
Regarding expiring advertising visas
Provided that no decision modifying them or terminating has been pronounced, advertising visas the validity period to expire between 12 March and 1st December 2020 are extended by right until 31 December 2020.
BASG tariff Valid from July 1st, 2020
Ordinance of the Federal Office for Safety in Health Care on the Fee tariff according to GESG; this fee regulation applies to all attachments received by the BASG from 01.07.2020.
European implementation of Medical Device and IVD Regulations - Implications for Australia
In response, the Australian Government has committed to delay the commencement of a range of medical device reforms that are aligned with EU MD Regulations. Furthermore, the Government has committed to provide manufacturers with an additional six months after the EU MD Regulations commence in May 2021 (until November 2021) to leverage certificates granted overseas and minimise the disruption and potential regulatory burdens.
Alternative comparable overseas regulatory approvals
Specifically, the manufacturers' conformity assessment documents acceptable for both pre-market authorisation and post-market compliance now include:
- European certification: TGA will continue accepting valid EC Certificates issued in accordance with any of the Directives (medical devices, Active Implantable Medical Devices and IVDs) until their expiry date or May 2024, whichever is the earliest.
- Other comparable Overseas Regulatory approvals: TGA accepts appropriate approvals from the US FDA, Health Canada and Japan MHLW/PMDA, and certificates issued under the Medical Device Single Audit Program (MDSAP). These documents provide alternate pathways to support ARTG inclusion applications, and are defined by the Therapeutic Goods (Medical Devices—Information that Must Accompany Application for Inclusion) Determination 2018.
- TGA Conformity assessment certificate: Manufacturers may seek conformity assessment certificate for medical device and IVD from the TGA.
Transition to new GMP requirements: a notice about the implications of adopting the PIC/S Guide to GMP PE009-1
The TGA will adopt the current version of the PIC/S Guide to Good Manufacturing Practice for Medicinal Products PE009-14 (PIC/S Guide to GMP), excluding Annexes 4, 5 and 14, as the manufacturing principles for medicines and active pharmaceutical ingredients, with effect from 1 July 2020 as communicated on 4 May 2020. The PIC/S Guide to GMP is available from the PIC/S website.
This will replace the manufacturing principles adopted in 2018 by the TGA for the manufacture of medicines, active pharmaceutical ingredients and sunscreens: the PIC/S Guide to Good Manufacturing Practice for Medicinal Products PE009-13.
Guidance Document on Complaint Handling
This guidance document specifies the requirements on complaint handling for all medical devices. This document is applicable to establishments including exporters dealing with medical devices.
Check List for no Objection Certificate for Imports
Public notice released Check List for No Objection Certificate for Import of Un¬registered/Not Available Medical Device(S) under Medical Devices Rules, 2017
Cyber security improvements to address vulnerabilities related to Medtronic Conexus™ Telemetry
Medtronic is now releasing the second phase of software updates in the Medtronic programmers to address the issue. A local Medtronic representative can assist healthcare professionals in installing the Conexus™ Telemetry update on programmers in their patients' accounts. Thereafter, each patient’s device will automatically receive the updated software during device interrogation with an updated programmer at implant or the next regularly scheduled clinic visit. Healthcare professionals are advised that there is no need to schedule patients to come in outside of their planned, scheduled visits, as no patient harm has been reported due to this issue.
Update on Potential Longevity Estimator Error of Medtronic programmer and remote monitoring software applications for a subset of implanted cardiac device models
A Dear Healthcare Professional Letter has been issued by Medtronic International Limited to update healthcare professionals on the availability of software updates to correct the potential longevity estimator error of Medtronic programmer and remote monitoring software applications for a subset of implanted cardiac device models, as a follow-up to the communication issued in October 2019 to notify healthcare professionals on the issue. This letter highlights two phases of software updates, which will be released in June 2020 and late 2020. Patient management recommendations for healthcare professionals regarding the respective affected devices in each phase are also provided.