July 5, 2021 Regulatory Updates
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Medical Devices – Regulatory Updates – Asia Round Up – Jun 2021

Singapore (HSA)

1. HSA grants provisional authorisation for ‘BREFENCE GO COVID-19 BREATH TEST SYSTEM’ and ‘TRACIEX BREATHALYSER’ for detection of Covid-19 Infection

The Health Sciences Authority (HSA) has granted provisional authorisation for the COVID-19 breathalysers ‘BreFence Go COVID-19 Breath Test System’ and ‘TracieXBreathalyser’, on 17 May 2021 and 27 May 2021 respectively. These breathalysers detect COVID-19 infection by analysing breath samples from individuals and report the results in 1-2 minutes.

The two breathalysers were developed by local start-up companies and have been validated in clinical studies where their results have been compared to those of Polymerase Chain Reaction tests.Companies are required to collect relevant accuracy and safety data and monitor the real-world use of their tests. HSA also requires additional data from ongoing clinical studies to be submitted post-approval for HSA to ensure the continued safety and efficacy of these tests.

https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-grants-provisional-authorisation-for-brefence-go-covid-19-breath-test-system-and-traciex-breathalyser-for-detection-of-covid-19-infection

Malaysia (MDA)

2. Distribution and Supply of Medical Device Intended for Professional Use

The Medical Devices Authority (MDA) would like to inform that medical device intended by the manufacturer for professional use, such as IVD test kit, can only be distributed and supplied for medical professional use only. Only qualified and trained medical professionals are allowed to use this medical device by following its instruction for use and operating procedures.MDA will continue to monitor the distribution, sale and advertising of medical devices for professional use, including those advertised and marketed through online platformsto ensure safety and effectiveness of medical devices on the market.

In this regard, the MDA would like to remind establishment that distribution of this medical device to general public is strictly prohibited. Any breach of the registration conditions, may result in the revocation of the registration of the medical device as provided in section 9 of the Medical Devices Act 2012 (Act 737).

MDA would also like to remind that advertising for any medical device for professional use in any media for general public is not allowed at all and any person convicted of an offense related to advertising of medical device may be fined not exceeding three hundred thousand ringgit or imprisonment for a term not exceeding three years or both under subsection 44(3) of Act 737.

https://www.mda.gov.my/announcement/612-pengedaran-dan-penjualan-peranti-perubatan-untuk-kegunaan-professional.html

JAPAN (PMDA)

3. Pharmaceuticals and Medical Devices Safety Information No.383 June 2021

The PMDA has managed and operated the medical information database “MID-NET”(Medical Information Database NETwork) as part of its operations pursuant to the Act on Pharmaceuticals and Medical Devices Agency (Act No.192 of 2002) for the purpose of promoting sophistication of safety measures for pharmaceuticals, etc. by utilizing big data. Through collaboration with 10 healthcare organizations across Japan, MID-NET is capable of collecting and analyzing medical information (electronic medical record data, administrative claims data, etc.) ona scale exceeding 5.3 million patients (as of the end of December 2020). It is utilized by the MHLW/PMDA, pharmaceutical companies, and academia and the analytical results are utilized in considering safety measures. This section introduces our current and future efforts for MID-NET,for which 3 years have passed since its official launch in the fiscal year.

Reporting of safety information such as adverse reactions to the Minister of Health, Labour and Welfare is a duty of medical and pharmaceutical providers.

https://www.pmda.go.jp/files/000241088.pdf

Kazakhstan (NDDA)

4. Update on the portal “Expertise of medical devices

NDDA informed that the submission, acceptance of the application and the registration dossier (stage 2 of the launch) for the examination of medical devices from June 8, 2021 will be carried out through the TEMI portal – temi.dari.kz (hereinafter referred to as the Portal).
Reception of applications submitted before the launch will be carried out according to the old algorithm.

A.   In case of submitting applications for expertise without analytics (without samples), it will be enough to attach the following documents to the portal:

  • Application for examination in PDF format with the obligatory presence of a signature and a seal (in the absence of an EDS);
  • Document confirming payment;
  • Letter of justification for the examination without analytics;
  • Registration dossier.

B.   In the case of submitting applications with analytics (where the delivery of samples is required along with the application), the package of documents and samples must be attached in the “Samples” tab.
Tracking the stages of expert work will take place in your personal account on the TEMI portal.

https://www.ndda.kz/rightnews/obnovlenie-na-portale-ekspertiza-meditsinskikh-izdelii_1623072110

AUSTRALIA (TGA)

5. Custom-made medical devices – Information for sponsors, health professionals & manufacturers

The way that custom-made medical devices are regulated has changed

On 25 February 2021 a new framework for regulating personalised medical devices commenced. The framework includes a new definition for custom-made medical devices. The impact of the new definition is the majority of devices previously supplied under the exemption for custom-made medical devices no longer meets the definition of a custom-made medical device and will need to be included in the Australian Register of Therapeutic Goods (ARTG).

6. The TGA response to ACCC safety and information standards – Consumer goods with button batteries

Since 2016, the Therapeutic Goods Administration (TGA) has been assessing home-use medical devices, such as thermometers and glucose meters, to ensure they are designed in a way that button battery hazards for children are minimised. The TGA had relied on compliance with the Industry Code for Consumer Goods that Contain Button Batteries (link is external) published by the Australian Competition and Consumer Commission (ACCC), as well as requirements specified in relevant medical device standards, as guidance and requirements for manufacturers.

In December 2020, the Federal Government introduced four mandatory safety and information standards to reduce the risk of death and injury associated with access to button and coin batteries in consumer products, which has replaced the Industry Code.

The following two standards are the most applicable to sponsors and manufacturers of medical devices, as they relate to medical devices that may contain button batteries and are used in a home setting, such as thermometers, glucose meters, and hearing aids. Hearing aids (and their associated accessories) are considered exempt from the safety standard but must comply with the warning requirements in the information standard:

  • Consumer Goods(Products Containing Button/Coin Batteries) Safety Standard 2020
  • Consumer Goods(Products Containing Button/Coin Batteries) Information Standard 2020

7. GMP Clearances: Timeframes for transfers and name change applications

Recently we have experienced an increase in administrative change requests, either to change manufacturer name and minor address details or to transfer clearances between sponsors. This increase combined with the overall rise in applications received has resulted in us prioritizing assessments of GMP Clearances over administrative changes. We will endeavour to action your transfer request or name change application within a reasonable timeframe, however request patience during this period.

Transfer of sponsorship of GMP Clearances

While we aim to process simple transfer requests (less than five GMP Clearances) within 10working days, where all documentation is provided, including full contact information of the new sponsor contact person, where larger transfer requests are submitted, these requests will take longer to action.

To assist using resource allocation weak sponsors to provide advice regarding proposed transfers as early as possible. Where a significant number of transfers are requested, that is more than 30, we ask sponsors to identify which clearances are the most critical ones for transfer and to provide an indication of timeframes when they will require the transfer to be completed to allow product regulatory actions to be under taken.

8. Changes to ARTG inclusion process for non-measuring, non-sterile Class I medical devices

Changes to the process for including Class I non-sterile, non-measuring medical devices and Class 1 IVD medical devices in the ARTG

On 4 December 2020, the TGA inclusion process for Class 1 in vitro diagnostic (IVD) medical devices in the Australian Register of Therapeutic Goods (ARTG) changed. This follows similarchangesmadeon1October 2020, for Class 1 non-measuring, non-sterile medical devices.

This guidance outlines the key changes, and provides links to the TGA website pages to provide further information about including Class I medical devices and Class 1 IVD medical devices in the ARTG.

Summary of changes

  • Applicants need to provide a manufacturer’s Declaration of Conformity with their application to include the device in the ARTG, rather than simply hold in the is documentation such a document at the time they apply for inclusion.
  • The manufacturer’s Declaration of Conformity template for Class I non-sterile, non-measuring devices has been revised to be more user-friendly.
  • The TGA will assess applications for compliance with the legal requirements for Class I medical devices to be included in the ARTG.
  • After conducting the assessment:
  • The TGA may conduct non-mandatory audits of Class I medical device or Class 1 IVD applications where, for example, there are concerns regarding a kind of device or it appears from the application that:
  • You can check if your product is a medical device using the SME Assist tool.
  • All Class I medical devices and Class 1 IVD medical devices included in the ARTG will continue to be subject to post-market reviews , in accordance with the existing process.

PHILIPPINES (FDA)

9. Philippine FDA posts guidelines on the licensing of medical device supply chain players

The Philippine Food and Drug Administration (FDA) has released guidelines on how organizations in the medical device supply chain can use its eServices Portal System to apply for a license to operate (LTO).
FDA has worked for more than one year to streamline the LTO process. The effort has now resulted in the publication of a document setting out how traders, wholesalers, importers and exporters of medical and health-related devices can apply to obtain, renew and update an LTO.

HONG KONG (DOH)

10. Continuance of trial to accept marketing approval obtained from the National Medical Products Administration and the Ministry of Food and Drug Safety of Korea for listing application of medical devices under the Medical Device Administrative Control System (MDACS)

The Medical Device Division (MDD) extends the trial scheme on accepting the marketing approval from either the National Medical Products Administration (formerly known as China Food and Drug Administration) or the Ministry of Food and Drug Safety of Korea as proof of compliance of Class II/III/IV General Medical Device to the “Essential Principles of Safety and Performance of Medical Devices” (Technical Reference: TR-004) under the MDACS. The trial scheme will expire on 31 December 2021.

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