1. Addendum to FDA Circular No. 2021-002 Re: Full Implementation of Administrative Order No. 2018-0002 entitled “Guidelines Governing the Issuance of an Authorization for a Medical Device based on the ASEAN Harmonized Technical Requirements”

These guidelines shall cover Class B, C and D medical devices that are not included in the list of registrable medical devices based on FDA Circular No. 2020-001-A.Non-Notified Products Can Be Imported Without a CMDN through March 2022.

This Circular aims to provide guidelines for the transition period wherein the manufacturers, traders, and distributors/importers/exporters of medical devices covered by FC No. 2021-002 may apply for CMDN and may be allowed to manufacture, import, export, distribute, transfer, sell or offer for sale their medical device products pending the issuance of the CMDN.

This Circular shall take effect 15 days following its publication.

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

Philippines Releases New Guidance on Class A Medical Devices.

This issuance aims to guide the manufacturers, importers, distributors and all other concerned stakeholders regarding the list of medical devices classified as Class A and to help the industry to determine the appropriate authorization specifically Certificate of Medical Device Notification (CMDN) to secure for their medical device products that fall under Class A classification.

3. Classification of medical device pertaining to Dental under the provisions of Medical Devices Rules, 2017-Reg.

In connection with Medical Devices Rules, 2017 vide G.S.R. 78 (E) dated 31.01.2017 which is already implemented from 01.01.2018, in exercise of the powers conferred under sub-rule (3) of rule 4 of Medical Devices Rules, 2017, the undersigned hereby classifies the medical devious, 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.

List of devices are available in below web link or Official site of CDSCO India portal

4. Classification of medical device pertaining to Pediatrics and Neonatology under the provisions of Medical Devices Rules, 2017- Reg.

File No. 29/Nlisc.10312020-DC (150)

List of devices are available in below web link or Official site of CDSCO India portal

5. Classification of medical device pertaining to Urology under the provisions of Medical Devices Rules, 2017- Reg.

File No. 291Misc.103/2020-DC (145)

List of devices are available in below web link or Official site of CDSCO India portal

6. Classification of Medical Device pertaining to Obstetrical and Gynecological under the provisions of Medical Devices Rules, 2017- Reg.

File No. 29/Misc./03/2020-DC (181)

List of devices are available in below web link or Official site of CDSCO India portal.

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

Key Features of MDMC Online System for Establishment of License

• Online Fee Generation and Verification of Paid Challans.
• Online Submission of Applications for
• New Establishment
• Renewal of MDMC Licensing.
• Submission of data for existing license holders
• Tracking of Application.
• Automated R&I Receipt Generation.
• Generation of Computerized License Certificate

Application, Fee details, challan generation available in below web link.

8. Online Submission of License Applications of Medical Devices

An online system for processing of applications of establishment license to import or manufacture medical devices. The web portal and user guide is available on home page of DRAP website under the heading “DRAP MIS System”, titled MDMC Online System for Establishment of License (https:e.dra.gov.pk/login).

9. Phase 2 of Permit to use of Medical Devices

Circular No. I (24) 2021. Based on circular dated 19/3/2018 regarding the National Registry of Medical Devices and the Resolution No. (48) of 2020 On Medical Devices and Products’ Quality Control, article(8), Which states II that “All health care facilities must take Authority permit to use medical devices and products before using them . “ we are leased to inform you that NHRA is initiating the second phase of the national program of permit to use which includes providing the quality assurance certificates for the previously listed devices on Phase one of the program which reached the total of 21,631 edictal devices by sending the required documents to the edictal devices regulation team email: [email protected]

NHRA would like to emphasize on the importance of completing phase one of the program for those who didn’t yet provided the required list.

NHRA would also like to note that this project should be completed by the end of 2025 where all ‘ previously approved and registered medical device details will be uploaded on NHRA website .Your cooperation is highly appreciated in improving health services in the Kingdom.

10. Post-market review of ventilators, CPAP and BiPAP devices

The Therapeutic Goods Administration (TGA) has begun a post-market review of all devices in the Australian Register of Therapeutic Goods (ARTG) of the following kinds:

• continuous and non-continuous ventilators;
• acute care ventilators;
• ambulatory ventilators including continuous positive airway pressure (CPAP) devices; and
• bi-level positive airway pressure (BiPAP) devices.

11. Regulation of software based medical devices

Software is becoming increasingly important in medical devices and digital adoption more broadly. In addition, it is becoming more important as a medical device in its own right.

Rapid innovation in technology has driven significant changes to software function and adoption, giving rise to a larger number of devices able to inform, drive or replace clinical decisions, or directly provide therapy to an individual. Advances in computing technology and software production have led to a large increase in the number of software-based medical devices available on the market, requiring the implementation of reforms to ensure patient safety.

The following guidance is intended to provide information on the regulation that applies to software and apps which meet the legislated definition of a medical device in Australia.

12. Warning to consumers and advertisers about COVID-19 test kits

Warning to consumers about home self-test kits

The Therapeutic Goods Administration (TGA) warns consumers to be cautious when seeking to purchase products claiming to be home self-tests for COVID-19, either online or through other means.

Warning to advertisers about test kits

In response to the COVID-19 pandemic, the TGA has taken measures to ensure Australia has laboratory and point of care tests available that are able to detect COVID-19 infections. These measures are designed to facilitate the legal importation, manufacture and supply of these tests. The measures do not exempt these test kits from the operation of the TGA advertising framework.