November 3, 2022 Regulatory Updates
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Medical Devices – Asia Regulatory Updates Roundup, Oct 2022

INDIA (CDSCO)

Extension of last date for filing statutory forms prescribed under DPCO, 2013-reg

As several representations requesting for extension of last date for filing statutory Forms- III, V and VI in Integrated Pharmaceutical Database Management System (IPDMS) 2.0 have been received from industry associations/ companies, India’s National Pharmaceutical Pricing Authority (NPPA) has extended the deadlines for the submission of information mandated under the Drugs (Prices Control) Order, 2013.Typically, NPPA gives manufacturers 15 days after the end of each quarter to submit production and sales data for scheduled drugs and 15 days after a price revision to share details of changes to the maximum retail prices of medical devices and scheduled and non-scheduled drugs.

Notice regarding implementation of gazette notification vide GSR 754(E) dated 30.09.2022

The Central Drugs Standard Control Organization (CDSCO) has told state licensing authorities to accept hard copies of applications for medical device registration certificates after stakeholders complained that state authorities were refusing their applications.

At the end of September, India implemented rules that established registration certificates to sell, stock, exhibit and distribute medical devices as an alternative to the drugs sale license. The rules state that the applicant must apply to a state licensing authority using Form MD-41 to obtain a registration certificate, which applies to medical devices including in vitro diagnostics.

G.S.R. 777(E) 14 Oct 2022 Final notification for exemption of non sterile and non measuring Class A medical devices from licensing regime

This notification is applicable to all non-sterile and non measuring devices classified as Class A medical devices. The medical devices shall be registered through an identified online portal established for the purpose. Uploading of information for registration, how registration number is generated, import of Class A non-sterile and non-measuring medical device, import of registration number, maintenance of records, cancellation or suspension of registration are explained in this notification.

Classification of Medical Device pertaining to Oncology under the provisions of Medical Devices Rules, 2017

This is a guidance to applicants applying for import or manufacture of medical devices under Medical Devices Rules, 2017.

The medical devices of Appendix A pertaining to Oncology under Medical Devices Rules, 2017 were classified based on the intended use of the device, risk associated with device, and other parameters according to first schedule.

Classification of Medical Device Pertaining to Dental Under the provision of Medical Devices Rules 2017

This is a guidance to applicants applying for import or manufacture of medical devices under Medical Devices Rules, 2017.

The medical devices pertaining to dental under Medical Devices Rules, 2017 were classified based on the intended use of the device, risk associated with device, and other parameters according to first schedule.

HONG KONG (MDD)

Update of Renewal and Change Application Form for Listed Importers/Distributors

The Renewal and Change Application Form for Listed Importers/Distributors has now been updated. Importers and Distributors may use the same form to apply for Renewal of listing status and Change of information. The form number is now assigned as MD203 and is available on MDD website

AUSTRALIA (TGA)

The TGA’s approach to delays in medical device conformity assessment recertification

The Therapeutic Goods Administration (TGA) is issuing this guidance to inform sponsors (and, where relevant, manufacturers) about the general approach the TGA will take to the lapsing of conformity assessment documents due to delays in audits as a result of the COVID-19 pandemic, the transition in Europe to their new regulations, and the limitations on the current number of notified bodies designated under the European Medical Devices Regulation (MDR).

Reclassification of medical devices that are substances introduced into the human body via a body orifice or applied to the skin

The purpose of this guidance is to assist sponsors of medical devices that are substances for introduction into the body with meeting their obligations and outlines transitional arrangements to help comply with new regulations.

Fees and charges: summary from 1 October 2022

The TGA is required to recover its costs for all activities that fall within the scope of the Therapeutic Goods Act 1989, including the TGA’s public health responsibilities.

  • A fee is charged for a service, such as a product evaluation
  • A charge is a form of tax on regulated industry and is applied annually based on a 1 July to 30 June financial year

Guidance for viewing and responding to a notification on the Consent for Non-compliance Dashboard

This document provides guidance on how to view and respond to notifications related to medical devices that are part of an application for consent to import, supply, or export a medical device that does not comply with the Essential Principles (EPs).

Guidance for completing an application for consent to import, supply, or export a medical device that does not comply with the Essential Principles

This document provides guidance on how to successfully complete and submit an application for consent to import, supply, or export a medical device that does not comply with the Essential Principles (EPs).

Essential Principles – consent for non-compliance

Sponsors who have been granted consent to import, supply, or export medical devices that do not meet the Essential Principles are required to provide a submission to the TGA at the end of their consent period when their medical devices have returned to compliance. In addition, the TGA may request that sponsors respond to regulatory letters and other notifications related to the medical devices that are a part of a consent application.

Medical device patient information leaflets and implant cards

Sponsors who will not have compliant patient information materials in place by 1 December 2021 will need to apply for consent to import, supply, or export a medical device that does not comply with the Essential Principles to ensure continuous supply of an affected device. This includes payment of application fees and the approval from the delegate of the Secretary.

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