How to correctly fill in the application for registration of medical devices?

Any public service, including registration, begins with the submission of an application to the relevant authorities, in the prescribed form. In the same way, when medical device registration application is executed according to the order KR-DSM-10 in electronic format through the portal "Expertise". If the applicant plans to register for the first time, it is necessary to sign an agreement with the National Center and pay the state duty according to the trade name before filing. One application shall be submitted for one trade name.

What's important to consider?

The application is one of the most important documents in the dossier, as NCELS experts take information for transfer to the state register from it. It is filled out electronically, through the client's personal cabinet on the portal. There are 21 items to be filled in, and we will dwell on each of them, highlighting the most important points.

1. type and type of examination. It is necessary to put a check mark against the proposed three types of procedure: new registration, introduction and renewal of the RI. In case of the latter, the number of the current RI should be indicated.

2. trade name. It is recommended to think over the trade name and its translation into Kazakh, adapted to the realities of the market, in order not to edit the name after the submission of the dossier.

3-4. Global and Kazakhstan nomenclature code. Experts pay attention to the above code when making a decision on splitting or combining applications.

5-6. Scope of application and purpose. It is also important to combine several versions of performance in one application. The information provided in this section will be approved by experts, Kazakh experts and further will be published in the state register, where the tender commission necessarily refers to when participating in tenders.

7. Type of product. Whether the item is a product or a technique. In the case of machinery, is it a closed or open system.

8. Brief technical characteristics. It is also important for various tenders and information from this section is published in the register.

9. Risk class. The specified class must match the declarations from the dossier.

10. Type of medical devices, sterility status and affiliation with IVD products. Applicable should be noted.

11. whether there are medicinal products in the composition. Indicated if applicable.

12. Accessories. This section describes all versions, accessories and consumables. As well as the availability of software. This is a very important section, since it is from this section that all the equipment is transferred to the state register. It should be noted that the most frequent changes are due to errors in the equipment. We in the company lcs-kz.com we take great care in completing this section.

13-16. Information on packaging, storage, and transportation requirements. The second important point in application for state registration of a medical device. This section, too, is directly linked to the registry, so any inaccuracies could result in future adjustments.

17. Registration of medical devices in other countries. Indicated if applicable.

18-19. Information on production cycles and addresses of offices and production site. It is important to enter all data from official documents and to check the correctness of data transfer to the state register.

20. Changes made are only filled in with the appropriate procedure, highlighting the revision before and after the adjustments.

21-22. Contractual data, bank details of the paying party

After filling in all the fields, the dossier itself is uploaded to the portal, as per the order. Application for state registration of a medical device, sample which previously could be downloaded and filled in, is now fully filled in electronically on the portal. The dossier is also uploaded electronically. If the submission of product samples is applicable to the application, a handover certificate is handed in, and if not applicable, a letter or certificate of full compliance with European directives must be enclosed instead of the certificate.

And only after all these steps are completed, it is possible to sign the document with the applicant's EDS and submit it to the experts of the first stage. In case of a positive assessment, the application proceeds to the stages of expertise, the progress of which can be monitored on the portal in the tab "Expert works".