Deadlines for registration of medical devices

It is probably unnecessary to say that regulation in different spheres of activity may differ greatly from country to country - it is obvious. In each country or region, public services have their own distinctive features. This also applies to the regulation of the medical market. These differences in regulation consequently affect the timeframe for the registration of medical devices. As we have previously written, the rules, as well as the duration of the entry into the register, are described in Order KR-DSM-10. Almost all manufacturers are concerned about the question "how long will it take?", and this is quite normal.

Is it possible to calculate the time in advance?

This calculation takes place even before the dossier is submitted to the authorized organization. However, it is quite difficult to do this precisely, since the final term of MI registration depends on the work of the state body, the activity of the manufacturer, and the workload of the consultancy. When consulting clients in our company, we always emphasize the importance of participation and interest of the plant (lcs-kz).

Therefore, when planning deadlines, you should not forget about preparing the package of documents, translation and notarization, agreement of the contract and official payments. This also takes a lot of time, especially for the collection of documents. It is very important to warn representatives of the factory that there is a large and important part of the work to be done, which will directly affect the timing of registration of the medical device. The better prepared we are before submitting the application, the faster and easier the examination will be. This is an important point, which many companies ignore and do not pay due attention to it. After all, when collecting information, post-marketing risks are also taken into account, ignoring which can lead to unfortunate consequences.

What does the duration of MI registration depend on?

In order to calculate how much time the whole process of registration of medical devices takes, You need to understand the stages that each application goes through when it is submitted to a national organization. And of course, it is necessary to know what type of application is being submitted - registration, re-registration or amendment. The timeframe for checking any product consists of two parts: the time spent by the NT specialist to review the materials and make comments, and the time spent to eliminate these comments. In other words, the order sets the Authorized Body time periods within which the entire verification must be carried out. If any deficiencies are identified, comments are issued through the single portal. The applicant, in turn, responds to them also within the calendar days established by the order.

Each stage of the work has its own timeframe. There are only four such stages, and they vary depending on the risk class of the product. For example: at the initial examination from 10 to 20 days, at the specialized examination from 40 to 70 days, in the laboratory from 30 to 60 days and at the safety conclusion - 30 calendar days. Applicants have 60 days to submit additional materials at the initial stage, and 90 days each at the specialized and laboratory stages. At the ZOB stage, comments are technical in nature and must be resolved within 30 days. However, there are cases when translators at this stage require corrections to the Kazakh translation, which may take additional time. The total number of days is already sufficient. 

After recommending the application and receiving a positive opinion, the applicant must pay the state fee to the committee for issuance of the RI and submit the corresponding application on the elicense.kz portal. Believe me, sometimes elementary payment takes a lot of time, with all the errors and refunds. The RI itself is issued within 5 working days, and in case of motivated refusal, the submission procedure is repeated again.

Is it possible to expedite expert work?

During the pandemic, the National Center had a service such as expedited registration of medical devices, and it was possible to order it for an increased state duty. Today, this option has been canceled, but many applicants still remember that it is possible to register goods in an accelerated manner. Officially, such a service is no longer available, and other ways of acceleration are unknown to us. But even if you are promised such a path, you should remember that fast registration of medical devices in most cases entails post-marketing risks, as the quality may suffer greatly. We have previously published an article on this topic. 

What else affects the registration period for medical devices?

In addition to the collection and submission of dossiers, full control at all stages, some manufacturers are audited by NCELS. The audit of the plant is carried out in parallel with the expert works, but it happens that due to the workload of the Inspection Department, the duration of preparation and visit to the audit may be longer than expected. 

Upon receipt of the notification, the applicant shall agree on the dates of the visit with the inspectorate and the plant within 30 days. The audit itself must be organized within 120 days from the date of the first notification. It should also be remembered that after the site visit, the inspectors have 30 days to prepare a report.

As we mentioned above, one of the important steps that takes a lot of time is the preparation of the registration dossier. It is important to take into account that not all manufacturers respond quickly to requests. And some legal processes, such as apostilization or legalization, can take up to several months.

And also, it should be taken into account that at any of the stages of the entire process, additional questions and even unsolvable situations may arise. This may result in a denial of registration. While we are waiting for a final decision on such controversial issues, the application may hang around waiting for the expert council.