Medical Devices – Asia Regulatory Updates round up – Aug 2021

Philippines (FDA)

1. Addendum to FDA Circular No. 2021-002 Re: Full Implementation of Administrative Order No. 2018-0002 titled “Guidelines for Issuing Authorization for Medical Devices Based on ASEAN Harmonized Technical Requirements”

These updated guidelines apply to Class B, C, and D medical devices, which were not previously included in the list of registrable devices in FDA Circular No. 2020-001-A. From now until March 2022, Non-Notified Products can be imported without a CMDN.
This Circular provides guidance on the transition period, allowing manufacturers, traders, and distributors/importers/exporters of medical devices covered by this FC to apply for CMDN and proceed with manufacturing, importing, exporting, distributing, transferring, selling, or offering medical device products for sale until the CMDN is officially issued.
The Circular will be in effect 15 days after its publication.

2. FDA Circular No. 2021-017 – New Reference List of Class A Medical Devices

The Philippines has issued new guidance for Class A Medical Devices to assist manufacturers, importers, distributors, and other stakeholders in identifying the appropriate authorization (Certificate of Medical Device Notification – CMDN) required for devices under this classification.

India (CDSCO)

3. Classification of Dental Medical Devices under the Medical Devices Rules, 2017

As per the Medical Devices Rules, 2017 (G.S.R. 78 (E), dated 31.01.2017), which were enforced starting January 1, 2018, the following classifications apply to dental medical devices. These classifications are based on factors such as intended use, associated risk, and other relevant parameters as outlined in the First Schedule of the Medical Devices Rules.
A list of dental devices is available for reference at the CDSCO India portal.

4. Classification of Medical Devices in Pediatrics and Neonatology under the Medical Devices Rules, 2017

The list of pediatric and neonatology medical devices has been classified under the Medical Devices Rules, 2017. The detailed classification is available on the CDSCO India portal.

5. Classification of Urology Medical Devices under the Medical Devices Rules, 2017

A detailed classification of urology-related medical devices has been issued in compliance with the Medical Devices Rules, 2017. The list is available on the CDSCO India portal.

6. Classification of Obstetrics and Gynecology Medical Devices under the Medical Devices Rules, 2017

A list of medical devices related to obstetrics and gynecology has been classified according to the Medical Devices Rules, 2017. More information can be found on the CDSCO India portal.

Pakistan (DRA)

7. User Guide for MDMC Online System for Establishment of License

The MDMC Online System allows online submission of medical device establishment licenses for importers and manufacturers. Key features include fee generation, application tracking, and automated license generation. Access to the user guide and related documents can be found on the DRA website.

8. Online Submission of License Applications for Medical Devices

An online system is now in place for the processing of establishment license applications for medical devices. Applications can be submitted via the DRAP website under the “MDMC Online System for Establishment of License” section.

Bahrain (DRA)

9. Phase 2 of the Permit for Use of Medical Devices

The NHRA is initiating Phase 2 of the National Registry of Medical Devices program. This phase includes providing quality assurance certificates for previously listed devices. Medical device manufacturers and distributors are reminded to submit the necessary documentation by the deadline of 2025 to ensure compliance.

Australia

10. Post-Market Review of Ventilators, CPAP, and BiPAP Devices

The Therapeutic Goods Administration (TGA) has commenced a post-market review of devices including continuous and non-continuous ventilators, acute care ventilators, CPAP, and BiPAP devices that are currently in the Australian Register of Therapeutic Goods (ARTG).

11. Regulation of Software-Based Medical Devices

Software is becoming increasingly integral to medical devices, and new regulations are being introduced to ensure patient safety. This guidance provides clarity on the regulation of software and apps that meet the definition of medical devices in Australia.

12. Warning to Consumers and Advertisers About COVID-19 Test Kits

The TGA has issued warnings about home self-test kits for COVID-19. Consumers are advised to exercise caution when purchasing such kits, and advertisers are reminded of the TGA advertising framework for medical devices.