Medical device registration dossier

Why is an enrollment file collected?

Basic material for the study of product safety - is the registration dossier. And its correct formation is the key to success. After all, it is this dossier that is thoroughly checked at the state expert examination through 4 different stages, where the safety and quality of the product is confirmed. It is for this reason that we at LIMI Consulting Service (lcs-kz) we pay great attention to its structure and analysis. So, a medical product registration dossier is not just a set of documents. It tells us everything about the product - what it is now and what we plan to do with it later.

Where to look?

The main order on the rules and conditions for entering drugs and medical devices into the registry is CR-DSM-10. Reading it, you will find all the necessary information, including a detailed list of requirements and conditions. It contains all provided documents of the registration dossier for MI. Also, the list tells us what information is needed for a particular type of product and in what format. And since there are a large number of varieties, the list is uniquely assembled for each individual case. Therefore, it is almost impossible to find an ideal sample medical product dossier.

How do I prepare for the collection?

Even before we start collecting the manufacturer's documents, we carry out an initial diagnosis on 4 points, based on the results of which we can draw the following conclusions: whether the goods need to be entered into the register, what costs are expected by the applicant, whether there will be an audit of the production site during the examination, whether it is necessary to provide samples to the laboratory and how long the whole procedure will take approximately. For this purpose we need: a license for free sale, a certificate of quality system, declarations of conformity, compliance with directives in Europe. Only after a positive diagnostic report, we can start correspondence with the manufacturer and prepare the necessary registration dossier for our medical device for registration purposes.

What's important to consider?

To avoid common mistakes, let's discuss a few important tips. Advice:

1. Obtain an accessory service from an authorized body to determine whether medical devices need to be registered. Applicable where the status of products is in question.

2. Undertake a free service to calculate the samples required. Applicable only if the provision of samples is required by law. As a result of the service, you will receive an official letter from NCELS and MI to be submitted to Customs.

3. To notarize official papers in the correct form. According to the order, there are documents that need to be apostilled or legalized. In CIS countries, however, they are notarized.

4. Prepare the production site for inspection, if applicable. You will need Order KR-DSM-315 to review this issue. In brief, the audit is applicable for the first application by a manufacturer of Class 2a, High Risk Group 2b and 3 sterile products.

5. Calculate all costs and timeframes expected by the manufacturer. The cost of services is available on the website of the expert organization.

6. The manufacturer must clearly understand which products by catalog numbers or articles he needs to enter in the register.

Re-registration

In case the manufacturer wants to extend the received certificate, if it has an expiration date, it is necessary to conclude an agreement, pay the state duty and collect a new dossier. But it is not as voluminous as in the primary process and consists of only two documents. It is a certificate for the quality management system ISO13485 and a report of post-marketing supervision for the time of operation of the RU on the market of Kazakhstan.

Amendments to the registration dossier

There is a need when a manufacturer wishes to make a number of adjustments to an existing registration certificate. Such a possibility exists, it is called a VIRD. For this purpose, it is necessary to conclude a contract, pay the state duty and prepare methodologically, because changes in the registration dossier for a medical device are divided into 11 types. Several amendments can be made at the same time, within the framework of one application. As a result, an addendum to the registration certificate is issued, in which the current information is indicated.