1. Addendum to FDA Circular No. 2021-002

This addendum supports the full implementation of Administrative Order 2018-0002 on ASEAN harmonized requirements. It applies to Class B, C, and D devices not included in the list of registrable products under Circular 2020-001-A.

Manufacturers, traders, and distributors may continue to manufacture, import, export, or sell their devices while CMDN applications are being processed. The circular becomes effective 15 days after publication.

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

This guidance lists Class A medical devices to help stakeholders determine whether a Certificate of Medical Device Notification (CMDN) is required for their products.

3. Classification of Dental Devices

Under the Medical Devices Rules, 2017, CDSCO has classified dental devices according to intended use and associated risks. The list in Appendix A may be updated periodically.

4. Classification of Pediatric and Neonatal Devices

A separate list covers devices used in pediatrics and neonatology. The list is available on the CDSCO website.

5. Classification of Urology Devices

Devices used in urology have been classified under the Medical Devices Rules, 2017. The list is posted on the CDSCO portal.

6. Classification of Obstetric and Gynecological Devices

A dedicated list is available covering devices used in obstetrics and gynecology. The list may be revised as required.

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 – Permit to Use Medical Devices

Based on Resolution No. 48 of 2020, healthcare facilities must obtain approval before using medical devices. Phase 2 includes submitting quality assurance certificates for devices listed in Phase 1 (over 21,000 devices). Medicaldevices@nhra.bh

The project is expected to be completed by the end of 2025, after which all approved devices will be listed on the NHRA website.

10. Post-Market Review of Ventilators and Respiratory Devices

The TGA has launched a review of ventilators, CPAP, and BiPAP devices listed in the ARTG.

11. Regulation of Software-Based Medical Devices

Due to rapid technological advancement, software used for diagnosis, treatment, or clinical decision support now falls under updated regulatory requirements. The guidance clarifies compliance expectations for software meeting the legal definition of a medical device.

12. Warning on COVID-19 Test Kits

Consumers are cautioned against purchasing unapproved home test kits. Advertisers are reminded that COVID-19 tests remain subject to TGA advertising requirements, despite pandemic-related supply measures.