January 6, 2021 Regulatory Updates
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Medical Devices – Regulatory Updates – January Volume 1

EUROPE

1. MHRA: Register medical devices to place on the market

The following devices in Great Britain (England, Wales and Scotland) need to be registered with the MHRA under existing arrangements:

  • Class I medical devices
  • IVDs
  • custom-made devices

All other classes of device placed on the Great Britain market require registration with the MHRA subject to grace periods, depending on the class of devices.

In Great Britain devices must conform to the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002) as they apply in Great Britain so that they can be registered with the MHRA.

Registration requirements under those regulations differ for Northern Ireland.

The MHRA will only accept registration of devices from manufacturers or UK Responsible Persons that have a place of business in the UK, or from Authorised Representatives based in Northern Ireland (for the purposes of the Northern Ireland market).

2. Regulating medical devices in the UK

Overview

The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating the UK medical devices market.

Summary of key requirements for placing a device on the Great Britain market

  • Since 1 January 2021, there have been a number of changes to how medical devices are placed on the market in Great Britain (England, Wales and Scotland). These are:
  • CE marking will continue to be recognised in Great Britain until 30 June 2023
  • certificates issued by EU-recognised Notified Bodies will continue to be valid for the Great Britain market until 30 June 2023, the EU no longer recognises UK Notified Bodies
  • UK Notified Bodies are not able to issue CE certificates (other than for the purposes of the “CE UKNI” marking, which will be valid in Northern Ireland) – and have become UK Approved Bodies
  • a new route to market and product marking is available for manufacturers wishing to place a device on the Great Britain market
  • since 1 January 2021, all medical devices, including in vitro diagnostic medical devices (IVDs), placed on the Great Britain market need to be registered with the MHRA. There is a grace period for registering:
  • Class IIIs and Class IIb implantables, and all active implantable medical devices and IVD List A products must be registered from 1 May 2021
  • other Class IIb and all Class IIa devices and IVD List B products and Self-Test IVDs must be registered from 1 September 2021
  • Class I devices, custom-made devices and general IVDs (that do not currently need to be registered) must be registered from 1 January 2022
  • manufacturers of Class I devices, custom-made devices and general IVDs that, prior to 1 January 2021, were required to register their devices with the MHRA (i.e. UK-based manufacturers or third country manufacturers with Northern Ireland-based Authorised Representatives) must continue to register their devices from 1 January 2021 on the same basis as they do now rather than in line with the above dates
  • if you are a manufacturer based outside the UK and wish to place a device on the Great Britain market, you need to appoint a single UK Responsible Person who will take responsibility for the product in Great Britain. Further detail on the UK Responsible Person is set out below

3. Announcement of the President of the Office of December 22, 2020 on electronic submission of notifications and notifications as well as sending documents related to EU Regulations 2017/745

In connection with the announcement on November 27, 2020 of the Regulation of the Minister of Health of November 3, 2020 amending the regulation on the method of submitting notifications and notifications regarding products (Journal of Laws, item 2095), from December 12, 2020, the following changes:

  • In order to facilitate the functioning of entrepreneurs trading in medical devices, the possibility of submitting reports and notifications by electronic means was introduced;
  • Information on medical devices for which the conformity assessment was carried out pursuant to the provisions of Regulation (EU) 2017/745 of the European Parliament and of the Council and Regulation (EU) 2017/746 of the European Parliament and of the Council, must be submitted using the forms specified in the Regulation on the manner of making notifications and product notifications.
  • Pursuant to the amended regulation of the Minister of Health, application forms and notifications may also be submitted to the Office in electronic form to the electronic mailbox of the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, after they have been signed with a trusted signature, personal signature or qualified electronic signature. The other requirements remain unchanged, the change applies only to the form of making, therefore, inter alia, all the required documents referred to in Art. 59 sec. 2 and art. 60 sec. 2 of the Act on Medical Devices, including forms in xml files.
  • In the field of products for which an assessment of compliance with Council Directive 90/385, Council Directive 93/42 or Council Directive 98/79 has already been carried out, and then assessment under Regulation (EU) 2017/745 of the European Parliament and of the Council and the European Parliament and Council (EU) 2017/746, there is no obligation to submit new notifications or updates. The cases specified in Art. 61 sec. 1b of the Act on Medical Devices (change of the name or address of the entity that made the notification or an authorized representative).
  • In the case of reports concerning:
    • a product that has not been previously placed on the market – it is necessary to submit a new notification with a fee
    • a product that was previously placed on the market (in accordance with Directive 90/385, Directive 93/42 or Directive 98/79) – it is necessary to inform about the changes pursuant to Art. 61a of the Act on Medical Devices.
    • At the same time, we would like to inform you that if the conformity assessment results in a change of the product class, it is necessary to submit a new application.
  • Where there is a change:
  • name or address of the producer not accompanied by a change in the National Court Register number or REGON identification number;
  • The name or address of the authorized representative;
  • Trade name of the product;
  • The number of the notified body that participated in the conformity assessment
  • It is necessary to notify the Office of the change of data covered by such a notification.

US FDA

4. New Guideline: Product Labeling for Laparoscopic Power Morcellators

The Therapeutic Goods Administration (TGA) has changed the name of the Clinical Trial Exemption (CTX) scheme to the Clinical Trial Approval (CTA) scheme.

This guidance contains recommendations concerning the content and format for certain labeling information for laparoscopic power morcellators (LPMs). The recommendations in this guidance reflect the state of the science and available technology regarding use of LPMs and are being made in light of scientific information that suggests that the use of these devices contributes to the dissemination and upstaging of an occult uterine malignancy in women undergoing laparoscopic gynecologic surgery for presumed fibroids. FDA is also recommending that manufacturers incorporate into the labeling for these devices information providing greater specificity regarding the risk of use as it relates to age, information regarding the risk of spreading malignant and benign uterine tissue, and information regarding the use of LPM containment systems. These labeling recommendations are intended to enhance, but not replace, the physician-patient discussion of the benefits and risks of use of LPMs that uniquely pertain to individual patients. FDA believes this effort will promote the safe and effective use of LPMs when used for gynecologic surgeries.

CANADA (HC)

5. Notice: New regulations strengthening the post-market surveillance and risk management of medical devices in Canada

Changes to the regulations

Health Canada is making regulatory changes to the Medical Devices Regulations to strengthen the lifecycle approach to the regulation of medical devices by increasing post-market surveillance authorities. With these amendments, have implemented certain powers included in Vanessa’s Law and additional measures to improve post-market surveillance of medical devices. Together these will help to reduce the risk of medical devices and improve their safety, quality and effectiveness.

The post-market surveillance regulations amending the Medical Devices Regulations will improve ability to identify, assess and manage new risks for medical devices used in Canada.

Australia (TGA)

6. Post-market review of face masks: Overview

The Therapeutic Goods Administration (TGA) is undertaking a post-market review of face masks included in the Australian Register of Therapeutic Goods (ARTG). TGA introduces the review and provides guidance for suppliers and users of face masks.

7. Guidance on medical/surgical face masks and respirator standards – key performance aspects

The TGA is currently undertaking a post-market review of face masks included in the Australian Register of Therapeutic Goods (ARTG). The TGA is aware there are many different standards available to manufacturers; and we are familiar with differences between these standards. The TGA has also identified common areas of non-compliance against claimed standards throughout this review process. This Guidance intends to assist manufacturers in choosing appropriate standards and to set out the TGA’s expectations for performance testing of respirators, surgical respirators and medical/surgical face masks, before inclusion on the ARTG.

China (CMDE)

8. Announcement on the submission of the unique identification of medical devices in the eRPS system (No. 26 of 2020)

According to the “Announcement of the National Medical Products Administration, National Health Commission, and National Medical Insurance Bureau on Deepening the Pilot Program and Implementing the First Batch of Unique Identification of Medical Devices” issued on September 30, 2020 (No. 106 of 2020), January 2021 The implementation of the first batch of unique identification for medical devices will be fully launched on the 1st.

In accordance with the relevant requirements of the “Notice of the State Drug Administration on Doing a Good Job in the First Batch of Issues Concerning the Implementation of the Unique Identification of Medical Devices” (No. 72 of 2019), for inclusion in the “Catalogue of the First Batch of Products with the Implementation of Unique Identification of Medical Devices For the medical device in the attachment), when applying for the first registration, renewal or registration change, the applicant or registrant shall submit the product identification of its smallest sales unit (hereinafter referred to as UDI-DI) in the registration management system. The relevant notices submitted by UDI-DI are as follows:

1.     Starting from January 1, 2021, for medical devices listed in the “First Batch of Products with Unique Identification of Medical Devices”, applicants or registrants will be in the eRPS system When submitting the application form for medical device product registration, renewal of registration, or registration change, the UDI-DI related information should be filled in and uploaded according to the template provided on the page.

2.     Starting from January 1, 2021, for medical devices listed in the “First Batch of Product Catalogs Implementing Unique Identification of Medical Devices”, if UDI-DI is not filled in the application form according to the above requirements, the application form cannot be submitted and registered The application materials will not be signed.

3.     UDI-DI is not a matter of registration review and is created by the applicant or registrant in accordance with the “Medical Device Unique Identification System Rules”

4.     The submission requirements of other attachments of the application form remain unchanged announce.

India (CDSCO)

9. Public Notice

Regulation of Blood Glucose monitors Blood pressure monitors Nebulizers and Thermometers as drugs with effect from Jan 1st 2021.

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