Medical Devices-Regulatory Updates-Asia Round Up-Jul 2021

Malaysia (MDA)

1. Malaysia’s MDA updates guidelines for testing medical face masks

Malaysia’s Medical Device Authority (MDA) has updated its guidelines for the testing of medical face masks in response to the COVID-19 pandemic.

The requirements, which MDA communicated in written guidance and an infographic, describes the different types of medical face masks and respirators and their labeling requirements. MDA also used the guidelines to set minimum performance and testing requirements based on resources from bodies such as ASTM International and the European Committee for Standardization.

MDA wants manufacturers to refer to the guidance when registering a medical face mask and respirator. The agency has also created a tool which healthcare facilities and the public can use to check the registration of a face mask.

Singapore (HSA)

2. Consultation on regulatory guidelines for classification of Standalone Medical Mobile Applications (SAMD) and Qualification of Clinical Decision Support Software (CDSS)

Consumer, Healthcare professional, Industry member, Medical devices Published:

The Medical Devices Branch (MDB) has released a draft Regulatory Guidelines for Classification of Standalone Medical Mobile Applications and Qualification of Clinical Decision Support Software (CDSS) for stakeholders’ consultation.

This document draws reference from the international Medical Device Regulators Forum (IMDRF)’s guidance on Software as a Medical Device (SaMD) to provide an internationally harmonized approach to determining the risk classification of a Standalone Medical Mobile Application (SaMD).

In addition, the guidelines provide better clarity on qualification of Clinical Decision Support Software (CDSS) as medical devices as well as the regulatory approach for such software. We would like to invite our stakeholders to provide feedback on this document:

The Consultation period for this document is from 19 July 2021 to 19 August 2021. Please email your feedback using the prescribed feedback form to HSA_MD_INFO@hsa.gov.sg by 19 August 2021. Please indicate “Regulatory Guidelines for SaMD Classification and Qualification of CDSS” in the email subject header.

Saudi Arabia (SFDA)

3. MDS-G25, Guidance on Requirements for Storage, Handling and Transportation of Medical Devices.

Requirements for Storage, Handling and Transportation of Medical Devices. The original version of this guidance document appeared in 2018. Version 2.0 features new requirements for importers and distributors involved in the storage, handling, and transportation of medical devices.

India (CDSCO)

4. Classification of In Vitro Diagnostic Medical Devices under the Provisions of Medical Devices Rules, 2017

File No. IVD/MISC/196/2020) -Safety, quality and performance of Medical Devices and In vitro Diagnostic Medical Devices are regulated under the provisions of the Drugs and Cosmetics Act, 1940 and rules, made there under.

For the regulation of Medical Devices and In vitro Diagnostic Medical Devices with respect to the import, manufacture, clinical investigation, clinical performance evaluation, sale and distribution, the Central Government, after consultation with the Drugs Technical Advisory Board, has notified Medical Devices Rules, 2017 vide G.S.R. 78(E) dated 31.01.2017 which is already implemented from 01.01.2018.

In this connection, in exercise of the powers conferred under sub-rule (3) of rule 4 of Medical Devices Rules, 2017, the undersigned hereby classifies the In vitro Diagnostic Medical Devices based on the intended use, risk associated with the device and other parameters specified in the First Schedule.

List of In vitro Diagnostics Medical Devices placed at Annexure A, Annexure B and Annexure C is subjected to the followings:

1. General intended use given against each of the device is for guidance to the applicants who intends to furnish application of import or manufacture of medical Devices under the provisions of Medical Devices Rules, 2017. However, as device may have specified intended use as specified by its manufacturer.

2. List in below mention web link is dynamic and is subjected to revision from time to time under the provisions of the Medical Devices Rules, 2017.

5. Classification of Medical Device pertaining to Rehabilitation under the Provisions of Medical Devices Rules, 2017

CDSCO File No. – 29/Misc./03/2020-DC (160) -Safety, quality and performance of medical devices are regulated under the provisions of the Drugs and Cosmetics Act, 1940 and rules made there under.

List of medical devices placed at Appendix A subjected to the followings:

1. General intended use given against each of the devices is for guidance to the applicants intends to furnish application of import or manufacture of medical devices under the provisions of Medical Devices Rules, 2017. However, a device may have specific intended use as specified by its manufacturer.

2. This list is dynamic in nature and is subject to revision from time to time under the provisions of the Medical Devices Rules. 2017. (Dr. V. G. Somani) Drugs Controller General (India).

6. Classification of Medical Device pertaining to Cardiovascular under the Provisions of Medical Devices Rules, 2017

File No.29/Misc./03/2020-DC – Safety. Quality and performance of medical devices are regulated under the provisions of the Drugs and Cosmetics Act. 1940 and rules made there under. For the regulation of medical devices for them with respect to the import, manufacture, Sale and distribution, clinical investigation, Central Government, after consultation with the Drugs Technical Advisory Board, has notified Medical Devices Rules. 2017 vide G.S.R. 78 (F) dated 31.01.2017 which are to be commence from 01.01 2018.

In this connection, in exercise of the powers conferred under sub-rule (3) of rule 4 of Medical Devices Rules 2017, the undersigned hereby classifies the medical devices, based on the intended use, risk associated with the device and other parameters specified in the First Schedule of the Medical Devices Rules-2017.

List of medical devices placed at Appendix A subjected to the followings:

1. General intended use given against each of the devices is for guidance to the applicants intends to furnish application of import or manufacture of medical devices under the provisions of Medical Devices Rules, 2017. However, a device may have specific intended use as specified by its manufacturer.

2. This list is dynamic in nature and is subject to revision from time to time under the provisions of the Medical Devices Rules, 2017 (Dr. V. G. Somani) Drugs Controller General (India).

7. Classification of Medical Device pertaining to Interventional Radiology under the Provisions of Medical Devices Rules, 2017

CDSCO File No. 29/Misc./03/2020-DC (146) Date: Safety, quality and performance of medical devices are regulated under the provisions of the Drugs and Cosmetics Act, 1940 and rules made there under.

In this connection, in exercise of the powers conferred under sub-rule (3) of rule 4 of Medical Devices Rules, 2017, the undersigned hereby classifies the medical devices, based on the intended use, risk associated with the device and other parameters specified in the First Schedule of the Medical Devices Rules-2017.

List of medical devices placed at Appendix – A subjected to the followings:

1. General intended use given against each of the devices is for guidance to the applicants intends to furnish application of import or manufacture of medical devices under the provisions of Medical Devices Rules, 2017. However, a device may have specific intended use as specified by its manufacturer.

2. This list is dynamic in nature and is subject to revision from time to time under the provisions of the Medical Devices Rules, 2017. (Dr. V. G. Somani) Drugs Controller General (India).

8. Classification of Medical Device pertaining to Dermatological & Plastic Surgery under the Provisions of Medical Devices Rules, 2017

CDSCO File No. 291Misc./03/2020-DC (147) – Safety, Quality and performance of medical devices are regulated under the provisions of the Drugs and Cosmetics Act 1940 and rules made there under. For the regulation of medical devices for them with respect to the import, manufacture, Sale and distribution, clinical investigation, the Central Government, after consultation with the Drugs Technical Advisory Board, has notified Medical Devices Rules. 2017 vide G.S.R. 78 (F) dated 31.01.2017 which are to be commence from 01.01 2018

In this connection, in exercise of the powers conferred under sub-rule (3) of rule 4 of Medical Devices Rules 2017, the undersigned hereby classifies the medical devices, based on the intended use, risk associated with the device and other parameters specified in the First Schedule of the Medical Devices Rules-2017.

List of medical devices placed at Appendix A subjected to the followings:

1. General intended use given against each of the devices is for guidance to the applicants intends to furnish application of import or manufacture of medical devices under the provisions of Medical Devices Rules, 2017. However, a device may have specific intended use as specified by its manufacturer.

2. This list is dynamic in nature and is subject to revision from time to time under the provisions of the Medical Devices Rules, 2017.

South Korea (MFDS)

9. Designation status of Clinical Performance Testing Institution

Ministry of Food and Drug Safety Notice No. 2021-256

In accordance with Article 8 of the In Vitro Diagnostic Medical Devices Act and Article 20 of the Enforcement Regulations of the same Act, the ‘Status of Designation of Clinical Performance Testing Institutions (2021.07.16) is posted as an attachment in official site.