Table of Contents
Medical Device Registration in Pakistan
Status of registration (as of 2021)
Are you interested in the status of your product registration in Pakistan?
If so, you could visit DRAP’s website here and check whether your application has been submitted by performing the following:
Divisions >> Medical Devices >> Provisional List Form 7-A Punjab.
If your product us approved, you would be able to see this in:
Divisions >> Medical Devices >> Provisional List Registered-Enlisted Medical Devices under MDR, 2017 – Registration Import
However please note that it may take some time before the list gets updated.
Manufacturer Detail needed for medical device registration in Pakistan:
Provide the details of the manufacturer. The details also include complete address, telephone number, fax number and its official website:
If the manufacturing process of a medical device consists of a number of sub-assembly processes, the details of all manufacturing sites where each of these sub-assembly processes are carried out must be provided along with processes:
If multiple sites manufacture the same product, details of each of these sites must be provided including design and manufacturing activities:
Credentials of the manufacturer abroad duly notarized in the country of origin:
Product details
Medical device brand name:
Medical device generic name:
HS code for the medical device, if applicable:
GMDN code for the medical device, if applicable:
Does the medical device contain any active ingredient, poison or drug?
Detail of manufacturing and quality control processes.
Class of medical device or accessory or component whether Class B, Class C or Class D
Shelf life supported with stability studies:
Proposed MRP of medical device:
Storage condition:
Is the medical device for export only?
Proof of fee deposited:
Original Agency agreement from Market authorization Holder duly notarized from the country of origin.
Free sale certificate in the country of origin duly attested by Embassy of Pakistan.
Whether the product is available on free sale in reference countries provided in rule 67 of Medical Devices Rules, 2017, Please attach original and valid free sale certificate duly attested by embassy of Pakistan.
Grouping of medical devices for medical device registration in Pakistan :
Single Set Family System Kit Cluster
List the constituent-components or medical devices that are grouped together:
Description of the accessories, other medical devices and other products that are not medical devices, which are intended to be used in combination with the medical device;
Description or complete list of the various configurations of the medical device to be registered using the format under these rules
Complete description of the key functional elements, its formulation, its composition and its functionality;
Production Quality Management System Certificate ( ISO 13485)/ GMP Certificate duly notarized in the country of origin:
Full Quality assurance certificate or equivalent as applicable duly notarized in the country of origin:
Design Examination certificate, as applicable duly notarized in the country of origin;
Brief Description of the Medical Device with intended use;
Specimen of Label as approved in country of origin
Essential principle of safety and performance.
Declaration of conformity (DoC):―Please attach the complete, signed and attested DoC. The DoC need to be printed on the manufacturer‘s letterhead, filled and signed by the responsible person.
Description of the medical device with intended use;
From this section onward , information is only applicable for those medical devices not approved or allowed for free sale in reference countries mentioned in rule 67 of Medical Devices Rules, 2017.
Technical Information for medical device registration in Pakistan
Complete description of the medical device with intended use;
Explanation of novel features, if any;
Indications that the device will diagnose, treat, prevent, cure or mitigate;
Contraindications;
Warnings to inform on specific risk or hazard that a user needs to know before using the medical device;
sample of labels on the medical device and its packaging;
Instructions for installation and maintenance, if applicable;
Any information and instructions given to the patient, including instructions for any procedure the patient is expected to perform, if applicable.
Promotional material and product brochures.
Sample of labels on the medical device and its packaging;
Information on validation for medical devices with sterile or with measuring function, where applicable:
Provide complete documentation related to the manufacturing and quality control processes.
