Final GSR 356(E)_Insert rule 43A for Suspension and cancellation of license in MDR 2017
The CDSCO has added a section on the suspension and cancellation of licenses to the Medical Devices Rules, 2017. If the manufacturer or licensee fails to comply with any of the conditions of an import license, the central licensing authority will give the licensee a chance to set out why it should not pass an order against the organization for noncompliance. Licensees that fail to successfully argue their case could face the cancellation or suspension of regulatory licenses.

Updated list of laboratories for conducting a Performance evaluation of IVD reagents/kit

Check the below link for more information on the Updated list of laboratories for conducting a Performance evaluation of In vitro medical devices.

DRAP issues guidance on the submissions of Clinical Trials Applications

The guideline provides general guidance to the applicants in making new applications for clinical trials on therapeutic goods, or any subsequent submissions and regulatory requirements to be fulfilled. It also provides an outline on the procedure for submission, review, evaluation and approval of applications for the conduct of clinical trials.

DRAP issued Guidelines for Public Health Programs (PHPs) to promote Pharmacovigilance activities and enhancing collaboration with National Pharmacovigilance Centre, DRAP

Drug Regulatory Authority of Pakistan (DRAP) aims at providing a holistic system of Pharmacovigilance in the country. Public Health Programs are key stakeholders involved in the reporting, assessment and risk communication of various un-wanted effects arising after the use of drugs, vaccines and other therapeutic goods.

Notice of the General Department of the State Food and Drug Administration on Comprehensively Strengthening the Consultation on the Quality and Safety Risks of Medical Devices

In order to fully implement the “Regulations on the Supervision and Administration of Medical Devices”, carry out in-depth special rectification of medical devices, and effectively strengthen the investigation and management of potential risks of medical devices, it is now necessary to comprehensively strengthen the quality and safety of medical devices..

Circular of the Center for Device Review of the State Food and Drug Administration on Issuing the Guidelines for the Registration Review of CT Image-Assisted Detection Software for Pulmonary Nodules (No. 21, 2022)

In order to further standardize the management of CT image-assisted detection software for pulmonary nodules, the Center for Device Review of the State Food and Drug Administration organized and formulated the Guidelines for Registration and Review of CT Image-assisted Detection Software for Pulmonary Nodules, which are hereby released. For more information please check the below link.

Announcement on the release of the recommended path for clinical evaluation of related products in sub-categories 11, 12, 13, 14, 15, 17, and 22 of the “Medical Device Classification Catalog” (No. 20 of 2022)

In order to further guide registration applicants to determine the clinical evaluation path of specific products, the Center for Device Review shall, in accordance with the relevant provisions of the Regulations on the Supervision and Administration of Medical Devices, and the technical guidelines for decision-making on whether to carry out clinical trials of medical devices.

Updated information on clinical trials conducted from a humanitarian point of view (pharmaceutical products, equipment/regeneration)

PMDA has updated the list of contact information for clinical trial submitters. There are various methods for contacting the clinical trial submitter, such as telephone number, fax, and e-mail, but the contact method for registration is left to each clinical trial submitter. Please check the below link (Japanese language).

Implementation of information on the proper use of automatic external defibrillators and defibrillator electrodes for body surface

Notification regarding safety measures (medical equipment). PMDA has posted an implementation of information on the proper use of automatic external defibrillators and defibrillator electrodes for body surface. Please check the below link (Japanese language).

Second Edition Guidance Document MDA/GD/0009: Rules of Classification for General Medical Devices

This document applies to all products that fall within the definition of medical device that has been specified in the Guidance Document MDA/GD/0006: Guidance on The Definition of Medical Device, other than those used for the in vitro examination of specimens derived from the human body for which a separate document will bereferred.

Requirements for Clinical Trials of Medical Devices (MDS-REQ 2)

The purpose of this document is to specify and clarify the requirements for conducting clinical trials of medical devices within KSA. This applies to contract research organization (CRO) or other parties wishing to conduct clinical investigations of medical devices or clinical performance studies of in vitro diagnostics medical devices within KSA.

Regulations and Requirements for the clearance of medicines, pharmaceutical products, medical devices, and food products that arrive for pilgrims use

Check the below link for more information on Regulations and Requirements for the clearance of Products such as medicines, pharmaceutical products or medical devices and supplies that arrive with doctors accompanying Hajj campaigns coming through air, sea orland ports for emergency use by pilgrims during the duration of travel to reach the holy sites and impediments to the supply of food items.

Circular No. (19) 2022: To All Medical Devices Importers – Validation Period of the Medical Devices Quality Certificates Verification

The National Health Regulatory Authority announces for all importers of medical devices and suppliers that the medical device quality certificates verification via emails will return to the normal validation period (three months) instead of the temporary 6 month extension done during the pandemic.

Circular No. (18) 2022: To All Healthcare Facilities – Assigning a Post Marker Surveillance (PMS) Officer

As a part of NHRA role to ensure the safety of medical devices in post market phase, it strictly recommended from all healthcare facilities and authorized representatives to assign a PMS Officer who is responsible for handling medical devices reporting in the post market surveillance stage including field safety notices, adverse events and complain reporting to NHRA.

Review of Fees payable under the Medicines Act 1981

MEDSAFE has updated the fees for medicine and medical devices. The proposed increase in fees is consistent with the Treasury’s charging guidelines for cost-recovery. The proposed fees are targeted at cost recovery levels in accordance with a cost recovery model.
Medical Devices – Regulatory Statements to Foreign Governments (per statement) – $186

Regulation of software-base medical devices

Factsheet for Digital mental health: Software based medical devices has been added.