Application form to get license to import medical devices

REGULATORY DRUG AUTHORITY OF PAKISTAN FORM-2

[see rule 4 (2), 5 (1), 6 (3) and 8 (3) (a)]

APPLICATION FORM TO GRANT OR RENEW A ESTABLISHMENT LICENSE TO IMPORT MEDICAL DEVICES

Me / We ... ... ... ... ... ... ... ... ... of M / s ... ... ... ... .... .. ... ... for which I request the granting or renewal of the establishment license, to import medical devices ... ... or the approval of the proposed change with respect to the details provided in relation to ... establishment license to import medical devices in facilities located in …………….
No sir.
Description
Special
one)
Purpose of the application, yes;
Please select the appropriate column
(I)
Fresh / new application
(ii)
For the renewal of the establishment's license to import medical devices
(i) License number and date:
(ii) Validity date:
(iii) Last renewal date and its validity:
(iv) Attach license certificate and last renewal:
(iii)
Proposed change of any particular of a licensed establishment (in case of any proposed change, mention the details of the change
2)
Details of the establishment
Provide details about each one, when applicable
(I)
Name and address of the establishment:
(ii)
Type of property, that is, society, property, limited public, private limited, etc.
(iii)
Commercial register issued by the Registrar of Companies or any other authorized body:
(iv)
Medicine sale license issued by the provincial government.
(v)
Names of partners / owners / directors:
(saw)
Addresses of partners / owners / directors:
(vii)
Foundation date:
(viii)
Medicine sale license issued by provincial governments
(ix)
Details of equipment and machinery for storage and handling of medical devices:
No sir.
Name of the team
Do
Model
Capacity
(one)
(2)
(3)
(4)
(5)
3)
Detail of qualified technical person
(Attached copies of CNIC, photographs, titles, experience certificate and
Certificate of advice interested)
(a)
Names of qualified technical persons to supervise the sale, distribution or wholesale of medical devices
Qualifications of qualified technical person
(yes)
Other technical staff working in these departments:
4)
Proof of the deposited rate:
5)
Details of medical devices intended to be imported:
6)
Any other relevant information that may be required by the MDB.
STATEMENT
Certificate that the documents and information provided in this document are genuine and correct and, if it is determined that at any stage they are false or incorrect, this will lead to legal action under the Pakistan Drug Regulatory Authority Act of 2012 and the standards set there. This certificate must be duly notarized and signed and stamped by the Owner, the Executive Director, the Managing Director or an authorized official. In the case of an authorized authority, a letter from the owner of the establishment must be submitted.
COMPANY
Sworn affidavit of the partners / owners / directors and qualified persons, duly verified in the sense that they: -
I. must comply with the provisions of the DRAP Act of 2012 and the rules established there,
ii) have not been convicted of any crime of any court of law.
iii) inform MDB and the inspector as soon as possible when either party ceases to have an interest in the license issued under these rules
iv. will not sell or store any expired, spurious, deficient, unregistered, mislabeled, counterfeit or any device that violates the DRAP Act of 2012 and the rules established therein.
Names) ……………… ..
Designations ………… ..
Firms) …………… ..
Stamp…………………..
Date…………………….
Note:
 This form will also be used if a change is proposed with respect to the details provided in relation to the establishment licensed to import medical devices. For this purpose, the provision of relative information is mandatory.
 Provide a readable electronic copy along with the application on USB / CD.