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

Malaysia (MDA)

1. Updated Guidelines for Testing Medical Face Masks by Malaysia’s MDA

In response to the COVID-19 pandemic, the Medical Device Authority (MDA) of Malaysia has revised its guidelines for testing medical face masks. The updated guidelines, communicated via written documents and an infographic, detail the various types of medical face masks and respirators, along with their labeling requirements. MDA has also set minimum performance and testing standards based on resources from organizations such as ASTM International and the European Committee for Standardization. Manufacturers are advised to refer to these guidelines when registering medical face masks and respirators. Additionally, MDA has developed a tool that allows healthcare facilities and the public to verify the registration status of face masks.

Singapore (HSA)

2. Public Consultation on Regulatory Guidelines for Classification of Standalone Medical

Mobile Applications (SaMD) and Qualification of Clinical Decision Support Software (CDSS)
The Medical Devices Branch (MDB) of Singapore has released a draft set of regulatory guidelines aimed at classifying standalone medical mobile applications and defining the qualification of Clinical Decision Support Software (CDSS). This draft document references the International Medical Device Regulators Forum (IMDRF) guidelines on Software as a Medical Device (SaMD) to harmonize the approach to determining the risk classification of such applications. The guidelines also clarify how CDSS is regulated as a medical device. Stakeholders are invited to provide feedback on these guidelines during the consultation period from July 19, 2021, to August 19, 2021. Feedback can be submitted via email to HSA_MD_INFO@hsa.gov.sg.

Saudi Arabia (SFDA)

3. Updated Guidance on Storage, Handling, and Transportation of Medical Devices (MDS-G25)

The Saudi Food and Drug Authority (SFDA) has published an updated version of its guidance (MDS-G25) on the storage, handling, and transportation of medical devices. Version 2.0 introduces new requirements for importers and distributors involved in these processes, ensuring that medical devices are handled in compliance with safety and quality standards.

India (CDSCO)

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

In accordance with the Medical Devices Rules, 2017, the Central Government of India has classified in vitro diagnostic medical devices (IVDs) based on their intended use, associated risks, and other criteria outlined in the First Schedule of the rules. The classification helps guide manufacturers on the regulatory requirements for importing, manufacturing, and distributing IVDs. The list of classified IVDs is dynamic and may be updated periodically to reflect changes in regulations and technological advancements.

5. Classification of Medical Devices for Rehabilitation under the Medical Devices Rules, 2017

The Drugs Controller General (India) has issued classifications for medical devices used in rehabilitation, as per the provisions of the Medical Devices Rules, 2017. These devices are categorized based on their intended use and risk level. The classification list is subject to periodic revisions.

6. Classification of Cardiovascular Medical Devices under the Medical Devices Rules, 2017

The Indian government has issued a classification for cardiovascular medical devices, specifying their intended use, associated risks, and other factors. These guidelines, part of the Medical Devices Rules, 2017, ensure that cardiovascular devices meet the safety and performance standards required for import, manufacture, and distribution in India.

7. Classification of Medical Devices for Interventional Radiology under the Medical Devices Rules, 2017

Medical devices used in interventional radiology have been classified under the Medical Devices Rules, 2017. The classification provides guidance on their intended use, safety, and performance criteria, and the list is subject to periodic updates.

8. Classification of Dermatological & Plastic Surgery Medical Devices under the Medical Devices Rules, 2017

India’s classification of medical devices for dermatological and plastic surgery applications is based on the intended use, risk, and other factors, as outlined in the Medical Devices Rules, 2017. These guidelines assist manufacturers in ensuring compliance with safety and performance standards for these specialized devices.

South Korea (MFDS)

9. Status of Designation of Clinical Performance Testing Institutions

The Ministry of Food and Drug Safety (MFDS) of South Korea has posted the official status of designated Clinical Performance Testing Institutions. This is in accordance with the In Vitro Diagnostic Medical Devices Act and its enforcement regulations. The designation information is available on the MFDS official website.f Clinical Performance Testing Institutions (2021.07.16) is posted as an attachment in official site.