Common mistakes when registering medical devices: how to avoid them

The process of state registration itself is not technically simple and relatively lengthy. Many people may think that it is enough to have a quality and safe product, an internationally recognized brand name and an impeccable reputation of the manufacturer. We agree that this is also important and plays not a small role for a successful presence in the market. However, we can say from experience that there are questions from the regulator and even undesirable outcomes in relation to even the most world-famous companies. And the reason for all this is the dossier collected and submitted inappropriately. Accordingly, the quality of the submitted dossier directly affects the registration process.

Below we give examples of mistakes to avoid when drafting the application and submitting documents to the regulatory body responsible for the registration of medical devices.

What are the most common mistakes?

Many errors in the registration of medical devices are made due to incorrect assessment of post-marketing risks by manufacturers. In addition, this can happen in cooperation with incompetent consulting companies that do not prioritize such risks when collecting documents. We, at the company lcs-kz.com We are obliged to highlight all possible risks, communicate them to our clients and only then proceed to preparing the dossier. There is also a system of double control within the company. This is when the manager, leading the application, before submitting the dossier protects it in front of an expert, for evaluation from the outside. Thanks to this, the dossier does not contain inaccurate information and the risk of errors is minimized.

So, common problems of registration of medical devices

1. Our company supports projects from scratch, starting with obtaining a license for pharmaceutical activities. This applies more to domestic manufacturers, and when working out questions about the license, we stipulate the following important points: the availability of its own or reliable rental premises for production, applying for the necessary type of sub-activity. The most important thing when obtaining a license is to know that the RU is tied to the address of the site in the license. And any move or change of address will entail obtaining a new license. 

2 One of the main steps in working with local manufacturers is the development of documents and laboratory testing. At this stage, very important post-registration risks are taken into account, such as shelf life, biological and technical testing, combining and separating different models into one group and selecting the appropriate type of sterilization. With each of these developments, we discuss which risks need to be taken into account in the long term and what this may affect in the future. This is why a preliminary quality assessment of a medical device is necessary.

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Stability. When setting the shelf life of the product, it is important to take into account the shelf life of the raw materials from which the product is made, the type of packaging and the type of sterilization. When it comes to accelerated stability, it is necessary to know whether the components of the product can withstand elevated temperature and humidity.

Laboratory testing. When developing the regulatory document and test programs, our experts together with the client discuss the raw materials used and the functional characteristics of the finished product, and then select a suitable laboratory for testing under the agreed program.

Sterilization. When choosing the type of sterilization, it is important to consider the type of packaging and the raw materials used to produce the product. It is also important to consider the selection of an outsourcing service for product decontamination. Further, it is necessary to describe the entire sterilization process and sterility confirmation in a validation report.

More detailed information about the importance of research and other subtleties is always available on the company's website, in the section LCS Blogwhere we share our experiences and observations.

3. the third and final stage, where the main evaluation of medical devices takes place and where we lay down the risks, is the collection and submission of the finished product dossier to the National Center. The most important thing in this period, is to fully understand the client's objectives and agree on all the data to be filled in. According to our observations, more than half of the problems and inaccuracies during registration occur due to inconsistency of information between applicants and clients. It is very important to pay attention to filling out the application, because the specialists of the state body use these data to transfer them to the state register. Moreover, there is a final, technical stage - the safety assessment of medical devices, during which the applicant is given the opportunity to once again check his personal account and all the data. They will also influence the registration certificate.