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Inauguration of online system for the applications of Medical Devices

Yasir Mahmood Events, Medical Devices
The honorable Prime Minister of Pakistan has launched the “Digital System for Licensing & Registration of Medical Devices” of DRAP on July 21, 2025 in Islamabad.

We are thrilled to announce that the new MDMC Licensing and Registration module is officially launched.

This enhanced module has been designed to offer a more streamlined, efficient, and user-friendly experience for managing all MDMC licensing and registration activities.

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SRO.649(I)/2023: MRP fixation of Cardiac Stents

Asad Ullah Medical Devices, Notifications, SROs

Drug Regulatory Authority of Pakistan with approval of the Federal Government, in exercising its powers conferred by subclause (vii) of clause (c) of section 7 of the Drug Regulatory Authority of Pakistan Act2012 (XXI of 2012) readwith section 1 2 of the Drugs Act, 197 6 (XXXI of 197 6) has notified the maximum retail prices of cardiac stents as specified hereunder:-

Notification-of-Fixation-of-MRP-of-04-Cardiac-Stents-02.06.2023Download

Recall Alert: Medical Devices; Aquavent Neonatal Breathing Circuits by M/s. Armstrong Medical Limited, Ireland

Asad Ullah Medical Devices, Recall Alerts

Recall Alert

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DRAP Alert NoNo I/V/05-23-23
Action Date17th May 2023
Target Audience-Healthcare Professionals particularly working in the critical care areas of hospitals including Physicians, Pharmacists, and Nurses.
-Procurement Officers at Hospitals and Healthcare Institutions,
-Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores
Product(s) Affected AQUAVENT NEO Neonatal CPAP limb
(Ventilator breathing circuit)
Manufactured by: Armstrong Medical Limited, Northern Ireland, Distributed by M/s. Elate C.C (Pvt) Ltd. Karachi, Pakistan
Batch No. 230123 (230123 as per the list in the Field Safety Notice)
Problem / Issue Armstrong Medical Limited, Ireland received reports for their Neonatal Breathing Circuits for risk of patient harm as a result of tubing (and a connector attached to the tubing) disconnecting from the elbow within Neonatal Breathing Circuits. Accordingly, the manufacturing company has issued a field safety notice and initiated recall of the defective product from the international market including Pakistan. 
Action Initiated-The manufacturing company has initiated a recall of the affected lots of defective products from the market where it was distributed.

-All healthcare professionals working in critical care units of hospitals as well as pharmacists and chemists working at distributions and pharmacies should immediately check their stocks and stop supplying these lots of the product. The remaining stock should be quarantined and returned to the supplier/company.

-Distributors and pharmacies are advised to be vigilant and report any suspected batch of the product(s) in the supply chain to the DRAP using the online form, or through phone at +92 51 910 73 17, or by Email at gsms∂dra.gov.pk.

-Regulatory field force of all federating units (DRAP, Provincial Health Departments, and States) has also increased the surveillance in the market to ensure the effective recall of defective product(s).
Advice for Healthcare Professionals-DRAP requests increase vigilance within the supply chains of healthcare institutions and hospital pharmacies to identify and return this product’s defective batch(es) to the importer/company.

-Adverse reactions or quality problems experienced with this product may be reported to the National Pharmacovigilance Centre(NPC), DRAP using Adverse Event Reporting Form or online through this link.

-Please click here for further information on problem reporting to DRAP.
Advice for Consumers-Consumers should stop using this product bearing the affected batch number(s). They shall contact their physician or healthcare provider(s) if they have experienced any problem that may be related to using this Medical Device.

-All therapeutic products must be obtained from authorized licensed pharmacies /outlets. Their authenticity and condition should be carefully checked. If you have any doubts, please seek advice from your pharmacist.

    DRAP issued Consolidated Notification for Regulatory Fees

    Asad Ullah Advertisements, Alternative Medicines, Clinical Trials, Controlled Substances, Drugs, General, Licensing and Inspections, Medical Devices, Notifications, SROs

    Drug Regulatory Authority of Pakistan (DRAP) issued a consolidated notification of Regulatory fess for various functions and services. This notification is issued under the section (1) of section 20 of the Drug Regulatory Authority of Pakistan Act, 2012 (XX.I of 2012) read with sub-rule (3) of rule 4 of the Drug Regulatory Authority of Pakistan (Fee and Levy) Rules, 2022, and in supersession of all such previous Notifications. The Drug Regulatory Authority of Pakistan with the approval of the Policy Board has specified these regulatory fees. The Notification is provided as under: –

    DRAP-Consolidated-Fee-17.04.2023Download