Rules for amending the registration dossier for a medical device

Many manufacturers believe that the life cycle of an MI ends at the stage of obtaining a registration certificate. However, we should not forget that there are a number of important procedures in the post-marketing period as well. One of these procedures is amendment or IRD. 

What the procedure consists of V.I.R.D.?

As we all know, the production process is subject to changes and the market in general does not stand still, as a result of which manufacturers periodically have the need or necessity to change some data related to the product or the manufacturer himself. In such cases, it is necessary to contact the National Center and apply for the necessary adjustments. The rules for making changes to the registration dossier for a medical device are described in the order of the CD DCM 10.

The order details everything, including how to amend the registration file. The applicant submits information for signing an agreement to the expertise center, pays the state duty and prepares documents according to the list of types of possible entries. It should be noted that it is not prohibited to choose more than one type, in which case the state duty is multiplied by the number of types chosen.

What varieties of VIRDs are there?

All possible types of amendments to the registration dossier of medical are prescribed in Annex 7 of the Order. There are 11 types in total. The conditions and requirements are detailed in the form of a table, indicating the list of minimum necessary data to be submitted as part of the package of documents. However, each entry is unique and, accordingly, the documents may differ, even when applying for the same types of adjustments. All types of adjustments are summarized below:

1. The changes concern the name or other information of the manufacturer as a result of a rebranding, merger or buyout, but not the relocation of the production site itself. If the factory has moved to a new address, it is no longer a medical device wird. Such a case requires a new reg. certificate. In order to prove this particular type, the applicant must submit a new certificate for free sale.
2. When changing the authorized representative of the plant in the Republic of Kazakhstan, the applicant shall provide a new power of attorney and detailed details of the new representative. The clause is more often applicable to foreign manufacturers, but still sometimes occurs with domestic manufacturers as well.
3. A new or corrected trade name can also be entered into the register through this procedure. For this purpose, the manufacturer prepares an official letter on letterhead, with a detailed explanation of the reason for such a need, and confirmation that it does not affect the quality of the product.
4. The fourth item should be selected when there are changes in the composition of registered products. This applies to both increases and decreases in components. The manufacturer must also prepare a letter of justification.
5. If it is necessary to update the instructions for users, namely in terms of applications and contraindications, the manufacturer prepares clinical reports proving the safety of the products.
6. If the manufacturers of the accessories have changed, it is sufficient to prepare information regarding technical specifications. The experts are likely to request technical reports from the new manufacturers as well.
7. The shelf life of products can be increased or decreased. This requires a motivated letter and stability reports justifying the new shelf life.
8. Storage conditions may also change and this item also requires justification and stability reports. The factory will also hand over all documents that mention proper storage.
9. Quality control processes are one of the most important types of application because they are directly related to the quality of the product. Often such applications require samples to be submitted to a national laboratory to confirm new data.
10. Packaging that ensures the safety and integrity of devices does not change very often, as the manufacturer validates such processes in the early stages of development. Despite this, this type is no exception. When packaging materials are changed, the factory includes information on the quality of the new materials and their testing in the dossier.
11. Perhaps one of the most common changes is labeling. Manufacturers, often adapting to market dynamics, revise the appearance of goods. Any change requires notification to the expert body and, accordingly, the submission of new layouts.

In conclusion, we conclude that amending the registration documents for medical devices - is an important and necessary procedure for all manufacturers on the market. Due to the fact that VIRD is quite individual, we at LIMI Consulting Service (lcs-kz) we conduct an initial diagnosis as a matter of course to choose the right strategy.