April 5, 2021 Regulatory Updates
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Medical Devices – Regulatory Updates- April Volume 1

USA (FDA)

1. US FDA to stop authorizing new imported respirators under reissued Emergency Use Authorization

Umbrella EUA for Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (FFRs) (Reissued March 24, 2021)
On March 24, 2021, the FDA revised this EUA to authorize for emergency use only those respirators listed in the EUA’s Exhibit 1 as of the date of this reissuance. The FDA will no longer be reviewing requests and adding new respirator models to Exhibit 1 of this EUA.
The FDA explained that that the eligibility criteria have now been removed, and no additional FFRs will be added to Exhibit 1 from this point forward. Companies that have already requested the inclusion of their products in Exhibit 1 and are awaiting an FDA decision are advised in an updated FAQ page on non-NIOSH-approved respirators that their requests will not be approved and that they should pursue other options.

2. US FDA unveils online resource center for biocompatibility assessment

The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) published its new Biocompatibility Assessment Resource Center this month to help companies navigate requirements relating to ISO 10993-1. Users of the website are advised to read the agency’s guidance document on evaluating and testing biocompatibility for medical devices, which was finalized in September 2020, in full. After this is complete, they are presented with a list of recommended steps along with the online resources to facilitate them. Rather than comprising a collection of all existing FDA resources on biocompatibility, the resource center provides a generalized procedural guide intended to be suitable for most companies.

EUROPE

3. European regulators publish new Q&A on custom-made medical devices

The European Medical Device Coordination Group (MDCG) has issued a new document covering key questions and considerations regarding custom-made medical devices in the context of Medical Devices Regulation (MDR) compliance.

The new MDCG Q&A document identifies 10 key questions pertaining to which devices qualify as custom-made devices, or CMDs, as well as MDR-related obligations and compliance considerations manufacturers will need to address.

This Q&A is a high-level document aimed at addressing the most pertinent questions relating to custom-made devices falling under Regulation (EU) 2017/745 on medical devices (MDR). Further guidance on this subject may be elaborated by the MDCG, as appropriate. In accordance with Recital 5 of the MDR, certain references to International Medical Device Regulatory Forum (IMDRF) guidance documents and terminology included therein have been taken into account under this Q&A. Specifically, the MDR regulatory status of adaptable medical devices and patient-matched medical devices (introduced by IMDRF PMD WG/N49 FINAL: 2018) is clarified in this Q&A.

4. Swiss medic advises on transition to EU MDR

The Swiss Agency for Therapeutic Products (Swissmedic) has shared details of how the regulation of medical devices will change in the coming months as the EU Medical Device Regulation comes into effect on 26 May.

In preparation, Swissmedic alerted industry to a notice by Kofam, the Swiss portal for human research detailing how the rules will affect sponsors as well as investigators in medical device clinical trials in Switzerland.

Kofam is advising sponsors with pending applications to file missing documents promptly so the submissions can be concluded before the new rules take effect on 26 May. From 1 April, Kofam is asking sponsors to delay making new submissions for device clinical trials until 1 May “as there is no guarantee that the application can be concluded before the law changes.”

From 1 May, Kofam is strongly recommending that sponsors use the new documents and templates designed for the incoming regulations “for reasons of procedural economy.” Decisions on applications filed in May will likely be made after the regulations come into force.

The mechanism for submitting applications will remain the same until at least 2022. Beyond that, submissions via the delayed EUDAMED database may become possible.

5. Prior Notification of change in the law by Swiss medic

Harmonization of the legal provisions for issuing export certificates (FSC) and attestations
Issue of export certificates (Free Sales Certificates) and Manufacturing Certificates (MC) for medical devices

Prior notification when the revised Therapeutic Products Act (revTPA) enters into force on 26 May 2021, the legal provisions for issuing export certificates and attestations will be aligned with those of the European Union (MDR/IVDR).Art. 50 Para. 2 revTPA states:
If another State requires export certificates and attestations for medical devices destined for import, the Agency may, on application, issue such documents to the manufacturer or authorised representative domiciled in Switzerland.

For the checklist, forms Etc. find in below source

https://www.swissmedic.ch/swissmedic/en/home/medical-devices/md-export-certificates-fsc-mc/exportzertifikate_fsc_mc.html

6. Clinical trial of Medical devices

New requirements and changes to authorization practice as of May 2021

Changeover to parallel submissions on 1 May 2021

Please note that as of 1.5.2021 submissions (including any subsequent submissions) must be sent on the same day both to Swissmedic and to the responsible cantonal ethics committee. As of 26.5.2021, Swissmedic will only authorise trials if the ethics committee has granted approval of the same version of the trial documentation.

New forms and extended folder structure for submissions as of 1 May 2021

As up to now, applications are still to be submitted to Swissmedic via the eMessage portal and those to the ethics committee via BASEC. The forms and the eDok submission format are being adjusted. By 1.5.2021, Swissmedic expects to publish revised forms and an extended folder structure for submission of the files. From then on, please only use the new forms and the new folder structure.

New requirements regarding investigational devices without CE marking

From 26.5.2021, the requirements set forth in Annex 1 of Regulation (EU) 2017/745 (MDR) will apply to investigational devices. New requirements are being used by industry and hospitals to inform new product developments for some time, and Swissmedic thus already accepts the manufacturers’ declarations, standards lists and device requirement lists based on paragraphs 2.7. and 4.1. of Annex XV of the MDR.

For ongoing authorisation procedures, where authorisation will only take place after 26.5.2021, the missing documentation must be submitted. To avoid subsequent enquiries and delays, Swissmedic recommends that these documents already be submitted now.

Swissmedic is providing examples of the standards list and device requirement list as well. Please find in source link.

Serious adverse events (SAE) and device deficiencies – reporting in accordance with MDCG 2020-10

In the European Union, reporting in accordance with MEDDEV 2.7/3 is to be superseded as of 26.5.2021. From this date on, reporting in Switzerland too will be based on a new form.

MDCG 2020-10/1 Safety reporting in clinical investigations of medical devices under the Regulation (EU) 2017/745

Please note that the causal relationship “unlikely” in MDCG 2020-10 is no longer used. Such reports must be treated in the same way as those classified as “possibly”.

Australia (TGA)

7. Clinical evidence guidelines: Medical devices version 2.0

The Clinical Evidence Guidelines for medical devices are intended to provide guidance to manufacturers of medical devices (including In vitro diagnostic medical devices (IVDs)) on what constitutes clinical evidence and the process of clinical data generation and clinical evaluation to produce such clinical evidence. While this guideline refers to IVDs, it is acknowledged that the information provided at this point is incomplete.

Sections of this guidance provide specific information on the clinical evidence requirements for the following types of devices:

  • About the application for the digital certification (CA) certificate of the electronic application of medical device registration information system,
  • Regarding the registration

Supportive devices – meshes, patches and tissue adhesives

There is also a specific section (Section 10) on implantable medical devices in the magnetic resonance environment.

8. Therapeutic Goods Medical Devices – Application Form for Priority Applicant Determinations) Approval 2020

New legislative instrument

https://www.tga.gov.au/sites/default/files/therapeutic-goods-medical-devices-application-form-for-priority-applicant-determinations-approval-2020.pdf

9. Essential principles checklist (medical devices)

https://www.tga.gov.au/sites/default/files/essential-principles-checklist-medical-devices.pdf

10. Hepatitis B and C viruses IVD self-tests

The purpose of this document is to provide manufacturers and sponsors with guidance on the Therapeutic Goods Administration’s (TGA) expectations concerning clinical performance requirements (i.e. clinical sensitivity and specificity) and risk mitigations for in vitro diagnostic medical devices (IVDs) intended to be used as self-tests for hepatitis B virus (HBV) and hepatitis C virus (HCV).

11. Chlamydia, gonorrhea and syphilis IVD self-tests

Clinical performance requirements and risk mitigation strategies

The purpose of this document is to provide manufacturers and sponsors with guidance on the Therapeutic Goods Administration’s (TGA) expectations concerning clinical performance requirements (i.e. clinical sensitivity and specificity) and risk mitigations for in vitro diagnostic medical devices (IVDs) intended to be used as self-tests for Chlamydia trachomatis (chlamydia), Neisseria gonorrhoeae(gonorrhoea) and Treponemapallidum (syphilis).

12. Seasonal Influenza IVD self-tests

Clinical performance requirements and risk mitigation strategies

The purpose of this document is to provide manufacturers and sponsors with guidance on the Therapeutic Goods Administration’s (TGA) expectations concerning clinical performance requirements (i.e. clinical sensitivity and specificity) and risk mitigation for in vitro diagnostic medical devices (IVDs) intended to be used as self-tests for seasonal influenza.

CHINA (CMDE)

13. Notice of the State Drug Administration on Public Consultation on the “Measures for the Administration of Medical Device Registration (Revised Draft for Solicitation of Comments)”

In order to implement the “Regulations on the Supervision and Administration of Medical Devices” and further standardize the supervision and management of the production of medical devices, NMPA have drafted the “Administrative Measures for the Registration of Medical Devices (Revised Draft for Solicitation of Comments)”, which is now open to the public for comments. The public can provide feedback through the following channels and methods:

  • Log on to the Chinese Government Legal Information Network of the Ministry of Justice of the People’s Republic of China (website: www.moj.gov.cn, www.chinalaw.gov.cn) and enter the “Main Menu” on the homepage Opinions are put forward in the column of “Soliciting legislative opinions
  • Mailing address: Medical Device Registration Management Department of the National Medical Products Administration (No. 1, Beiluyuan, Zhanhua Road, Xicheng District, Beijing), postal code: 100037, with the words “Soliciting Opinions on the Administrative Measures for Medical Device Registration” on the envelope.
  • Email: ylqxzc@sina.cn. When sending an e-mail, please indicate “Feedback on Device Registration Measures” in the subject of the e-mail.
    The deadline for comments is April 25, 2021.

14. Notice of the State Drug Administration on Public Consultation on the “Administrative Measures for the Registration of In Vitro Diagnostic Reagents (Revised Draft for Solicitation of Comments)”

In order to implement the “Regulations on the Supervision and Administration of Medical Devices” and further standardize the supervision and management of the production of medical devices, NMPA have drafted the “Regulations for the Registration and Management of In Vitro Diagnostic Reagents (Revised Draft for Solicitation of Comments)”, which is now open to the public for comments. The public can provide feedback through the following channels and methods:

  • Log on to the Chinese Government Legal Information Network of the Ministry of Justice of the People’s Republic of China (website: www.moj.gov.cn, www.chinalaw.gov.cn) and enter the “Main Menu” on the homepage Opinions are put forward in the column of “Soliciting legislative opinions.
  • Mailing address: Department of Medical Device Registration Management of the State Drug Administration (No. 1, Beiluyuan, Zhanhua Road, Xicheng District, Beijing), postal code: 100037, and indicate on the envelope “In Vitro Diagnostic Reagent Registration Management Measures Soliciting Comments” Typeface.
  • Email: ylqxzc@sina.cn. When sending an e-mail, please indicate “Feedback on Reagent Registration Measures” in the subject of the e-mail.
    The deadline for comments is April 25, 2021.

15. NMPA publishes revised Chinese medical device regulations

The “Regulations on the Supervision and Administration of Medical Devices” (hereinafter referred to as the “Regulations”) were reviewed and approved at the 119th executive meeting of the State Council on December 21, 2020, and will come into force on June 1, 2021.

16. Announcement on the collection of paper documents for self-withdrawn medical device registration application items (No. 4 of 2021)

In accordance with the requirements of Article 40 of the “Administrative Measures for Medical Device Registration” and Article 50 of the “Administrative Measures for the Registration of In Vitro Diagnostic Reagents”, “For the registration application that has been accepted, the applicant may accept the application before the administrative licensing decision is made.
The Food and Drug Administration of the People’s Republic of China applied to withdraw the registration application and related materials, and explain the reasons.” Since 2014, center has been handling paper materials for the self-withdrawn medical device registration application items for registration applicants in need based on this. At the beginning of 2020, due to epidemic prevention and control requirements, this work was suspended. It is now planned to resume the collection of paper documents for self-withdrawn medical device registration application items from the date of this notice. Registration applicants are requested to comply with the certain requirements specified in source, for more information.

17. Notice on the public solicitation of opinions on the guidelines for the technical review of the second-class medical device registration in 2020

In accordance with the relevant requirements of the National Medical Products Administration’s 2020 medical device registration technical review guidelines project plan, our center has organized and compiled 22 second-class guidelines (attached 1) A draft for solicitation of comments has been formed, and comments will be publicly solicited online from now on. If you have any comments and suggestions, please fill in the feedback form (Annex 2) and send it back to the corresponding contact person (Annex 3) before April 17, 2021.

Thailand (FDA)

18. Publicized documents related to the preparation of the abnormal performance report of the medical device

Following documents made public:

  • Medical device AE reporting sheet
  • Medical device product recall guidelines for entrepreneurs
  • Guidelines for entrepreneurs to report
  • Manual for recording the surveillance report
  • Notification of the Ministry of Public Health Re: Rules, Methods and Conditions for Preparing a Report of Abnormal Operation of Medical Devices
  • FDA Notification Re: Report Forms According to the Ministry of Public Health Announcement

Kazakhstan (NDDA)

19. Conclusion of contracts and filing applications for payment for pharmaceutical inspections and medical device inspections

To all the portal “Expertise of medical devices” has been updated.In this update, it became possible to conclude contracts and submit applications for payment for conducting pharmaceutical inspections and medical devices through the Portal.
According to the algorithm in the Portal, contracts are concluded in a framework form with a validity period of 12 months (one contract – several applications for payment / application for inspection).
In new contracts, an invoice for payment is generated automatically after a payment request is created on the Portal. Invoices for payment are also uploaded through the Portal, after payment of the invoice, the request for payment is transferred to the “Active” status.
The possibility of submitting an inspection application through the Portal will be implemented at a later date.

Philippines (FDA)

20. Philippine FDA sets minimum performance requirements for COVID-19 tests

The Philippine Food and Drug Administration (FDA) has established minimum performance standards for different types of COVID-19 test. The standards are based on work by FDA and the World Health Organization (WHO).
FDA has set different requirements for PCR tests, antibody kits and antigen tests. The requirements for PCR and antibody tests are based on the work of Philippine agencies to determine acceptable performance. For PCR, FDA is requiring sensitivity of 95% and specificity of 99%. FDA is using WHO’s 80% sensitivity and 97% specificity benchmarks for antigen tests.
The Philippine regulatory agency said a “product profile indicating the specificity and sensitivity of the COVID-19 test kit shall be an additional requirement prior to the issuance” of clearance to sell a product under emergency COVID-19 measures. Clearances last six months. Companies with products already on the market will need to meet the new standards to retain their authorizations.

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