Get Application For Registration Of Medical Device ?product - Ministry Of ...

This guide provides detailed instructions on how to complete the Application For Registration Of Medical Device ?product form through an online process. By following these steps, users can ensure that they submit a complete and accurate application.

Follow the steps to successfully complete your application.

1. Press the 'Get Form' button to access the online application form. This will direct you to the form where you can provide the necessary information.
2. Begin by entering the details of the local distributor. Fill in the authorized distributor's name, contact person, street address, city, email, and telephone number.
3. Provide the detail of the drug store license, including the license number and renewal date.
4. Next, enter the details of the manufacturing site responsible for batch release of the finished product. Include the site name, address, contact details, and the latest Good Manufacturing Practice (GMP) certification information.
5. Fill out the details of the marketing authorization holder. Include their name, address, contact details, and a summary of the qualifications of the authorized person(s) who will be negotiating on behalf of the company.
6. Indicate the details of the active pharmaceutical ingredients (APIs) used in the product, including the API name, manufacturer details, GMP certification information, and any relevant regulatory approvals.
7. Provide product information such as the trade name, dosage form, active ingredients, strength, route of administration, pharmacotherapeutic group, and mode of dispensing.
8. Describe packaging details, including the patient information leaflet, shelf life, and storage conditions required for the product.
9. List the composition of the product. Include the names and quantities of active ingredients and excipients, along with their quality standards.
10. If applicable, detail any ingredients of animal origin used in the manufacturing process and provide a declaration regarding TSE (transmissible spongiform encephalopathy) safety.
11. Provide information on the regulatory status if the product has been approved in other countries, including the names of regulatory authorities and approval dates.
12. Include leaflet information that outlines therapeutic indications, dosage, contraindications, and warnings as required.
13. If the product is a generic, detail the bioequivalence study as per guidelines, including companies involved and necessary certificates.
14. Complete the pricing section by providing authenticated price certificates for the product.
15. Lastly, make sure to complete the declaration section confirming the accuracy of the information provided and include your name, signature, email address, and date.

Complete your documents online to ensure a smooth registration process.