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                                                                             An international pass for the manufacturer

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(A) Applicant Details
1.      Applicant’s company name, address and contact number.
2.      Name and address of foreign manufacturer (Manufacturing premises).
3.      Copy of the Plant Master File.
4.      Name and address of the local authorized representative.
5.      Name and address of the importer.
6.      Local manufacturer, if any processing is being done in the country.
(B) Product Information
1.      Proprietary/Brand name.
2.      Brief description of the device.
3.      Category of device.
4.      Intended use and method of use.
5.      Medicals specialty in which the device is used.
6.      Qualitative and quantitative particulars of the constituents.
7.      Brief description of the method of the manufacture and specification of the materials used.
8.      Contraindications, warnings, precautions potential adverse events and alternate therapy, wherever applicable.
9.      List of accessories and other devices or equipment to be used in combination with the device. Other descriptive information, including accessories packaged with the product.
10.  Variations in shape, style or size of the device, if applicable.
11.  Labeling details conforming to Drugs and Cosmetics Rules, 1945.
12.  Physician manual and promotional literature (Literature insert) in English.
13.  Packaging description including pack sizes.
14.  Recommended storage conditions.
15.  Summary indications of any reported problems.
16.  Details of standards to which the device conform alongwith the copy of the standard.
(C) Regulatory Status
1.   Approval of the product from any other regulatory agency (Separate evidence for the approval from the each agency)
(i)      US FDA clearance/approval.
(ii)    EU medical device directive (CE Certificate).
(iii)   Australia/Canada/Japan approval.
(iv)  Approval in any other country.
1.      Copy of ISO/EN Certification if any for the manufacturing facility.
2.      List of countries where the device is being sold.
3.      List of countries where device is withdrawn from sale with reasons,
if any.
(D) Master File (Details of Good Manufacturing Practices employed by the manufacturer to ensure quality of the device)
1.      Component/Material used.
2.      Device Master File.
3.      Manufacturing process/Flow Chart.
4.      Quality Assurance procedures/process controls.
5.      Final product testing or design inputs/outputs verification, if applicable.
6.      Functionality Test protocol and report, if applicable.
7.      Risk Assessment as per ISO 14971.
8.      Sterilization process and validation/verification.
9.      Stability data or statement of established stability of material used as applicable.
10.  Shelf life of the device.
11.  Biocompatibility and Toxicological data, wherever applicable.
12.  Device GMP Certificate.
(E) Devices containing medicinal product
1.      If device incorporates a medicinal product, which is liable to act upon the body with action ancillary to that of the device, data on the safety, quality and usefulness of the medicinal substance used.
2.      Data on compatibility with medicinal products, if device intended to deliver medicinal products.
3.      Clinical data and published articles, if any.
4.      Batch Release Certificate for products incorporating any medicinal substance or substances of animal origin.
5.      For devices not approve for marketing in the country of origin, the applicant shall submit reports of clinical trials, details of sales, certificates of satisfactory use from the medical specialists about the use of the device and details of product complaints, if any.
(Medical Devices with prior approval from any of the recognized regulatory authorities will be subjected to an abridged evaluation and only a summary of all the studies and information described above is to be submitted)
(F) Post Market Surveillance
1.      Procedures for distribution of records.
2.      Complaint handling.
3.      Adverse incident reporting.
4.      Procedure for product recall.