Checklist for Registration or Renewal of Class B, C & D Doc MDMC/LST/RI/ Ver 01
Medical Devices for Import # 006
CHECKLIST FOR REGISTRATION OR RENEWAL OF CLASS B, C & D MEDICAL
DEVICE OR ACCESSORY OR COMPONENT FOR IMPORT.
[Form-7A rule 14(2)(b), 16(1), and 17(2)]
Sr.# DESCRIPTION SELECT
(YES/NO/NA)
1. Application on Form-7A (Duly signed & stamped)
(i) New Application
(ii) For renewal (copy of registration letter and last renewal attached)
(iii) Provided the Change of any particular of a registered MD
(in case of any proposed change).
2. Proof of fee deposited: (endorsed by Statistical officer.)
3. Details of importer: (Attach copy of valid establishment license)
(i) Provided the Name & particulars of responsible persons:
(ii) Provided the details of any change in establishment licence:
4. Manufacturer Detail:
(i) Provided the details of the manufacturer, that include complete address,
telephone number, fax number, official website etc.:
(ii) Provided the manufacturing process of a MD consists of number of sub-
assembly processes at different manufacturing sites with details:
(iii) Provided the multiple sites manufacture the same product, details of each
sites including design and manufacturing activities:
(iv) Provided the credentials of manufacturer abroad duly notarized from the
country of origin.
5. Product details
(i) Provided the Medical device brand & generic name.
(ii) Provided the HS code/ GMDN code.
(iii) Provided that the MD contain any active ingredient, poison or drug;
(iv) Provided the details of manufacturing and quality control processes.
(v) Provided the class of MD with relevant rules;
(vi) Provided the shelf-life & storage conditions, i.e., justified with stability
studies:
(vii) Provided the Proposed MRP of medical device:
(viii) Provided the medical device is for export or to be placed only in local
market?
(ix) Provided the Original Agency agreement or letter of authorization from
manufacturer (legal) / owner or market authorization holder (MAH) or its
authorised distributer, containing name and complete address of
manufacturer, product or category of medical device(s) for which sole
authorization is given, validity of agreement, duly notarized by the country of
origin:
(x) Provided the Free sale certificate in the country of origin duly attested by
Embassy of Pakistan.
(xi) Provided the Original and valid free sale certificate of any RRA as per rule 67
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Checklist for Registration or Renewal of Class B, C & D Doc MDMC/LST/RI/ Ver 01
Medical Devices for Import # 006
duly attested by embassy of Pakistan.
(xii) Provided the Grouping of medical devices:
(xiii) Provided list of MD, constituents-components that are grouped together:
(xiv) Provided the description of accessories, other medical devices or products
that are not MD, are intended to be used in combination with:
(xv) Provided the complete list of various configurations to be registered;
(xvi) Provided the Complete description with intended use, Key functional
elements, formulation & composition with functionality:
(xvii) Provided the Production Quality Management System Certificate (ISO
13485)/ GMP Certificate duly notarized by the country of origin:
(xviii Provided the Full QA certificate or equivalent, duly notarized by the country
) of origin:
(xix) Provided the Design examination certificate (if applicable), duly notarized by
the country of origin
(xx) Provided the Essential principle of safety and performance.
(xxi) Provided the Declaration of conformity (DoC) to be printed on manufacturer
letterhead, filled and duly signed by responsible person.
(xxii) Provided label (as approved in the country of origin) and its packaging,
promotion material and brochure:
From this onward, information is only applicable for those medical devices not approved or allowed for
free sale in RRA as mentioned in rule-67.
6. Technical Information
(i) Provided the Explanation of novel features, if any;
(ii) Provided the Contraindications & Warnings to inform on specific risk or
hazard to use medical device;
(iii) Provided the instruction for use (IFU).
(iv) Provided the Information on validation for medical devices with sterile or
with measuring function,
7. Attached the documentation on software validation studies to verify the
correctness of software in medical device. The document shall include the
results of all verification, validation and testing performed prior to final
release. (For active medical devices.)
(i) Provided the Instructions for installation and maintenance;
8. As applicable, following information to be provided on medical devices
containing biological material:
(i) Provided the list of all materials of animal, human, microbial or recombinant
origin used in the medical device and in the manufacturing process of the
medical device, which includes animal or human cells, tissues or derivatives,
rendered non-viable cells, tissues or derivatives of microbial or recombinant
origin;
(ii) Provided the Detailed information of the selection of sources or donors;
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Checklist for Registration or Renewal of Class B, C & D Doc MDMC/LST/RI/ Ver 01
Medical Devices for Import # 006
(iii) Provided the Detailed information on harvesting, processing,
preservation, testing and handling of tissues, cells and substances;
(iv) Provided the Process full description of system for record keeping allowing
traceability from sources to the finished medical device.
(v) Provided the Report or certificate containing information on objectives,
methodology, results, discussion and conclusions of biocompatibility tests
conducted on materials used.
(vi) Attach the report or certification containing information on the objectives,
methodology, results, discussion and conclusions of the pre-clinical physical
tests conducted on the medical device.
(vii) Provided the Information on validation for medical devices with sterile or
with measuring function, where applicable:
9. Provided the DECLARATION (on stamp paper) as per Form-7A.
10. Provide readable softcopy of application in USB/CD.
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