The Registration Certificate is a document that confirms that a medical device or equipment has undergone the necessary registration measures. This certificate also confirms the compliance of medical devices with all established standards and norms, in addition, guarantees their reliability and safety.
Without a declaration of conformity and registration certificate for a medical device, its use is prohibited. Therefore, every manufacturer faces the procedure of obtaining permits. The certificate has an unlimited validity period and can be used for many years. But, unfortunately, there are often situations when it is necessary to obtain a duplicate of the registration certificate. But they are not always issued.
All issued registration certificates are entered into the state register of Roszdravnadzor. Therefore, obtaining a duplicate will not be difficult. Such a “replacement” of the registration document is possible only in two cases:
- When the certificate is lost.
- When the document is defaced.
Please note that duplicate certificates cannot be issued for any other reason, as this is not permitted by law.
Execution of a duplicate of the registration certificate: features and nuances
In order to obtain a duplicate of registration certificate for a medical device, the applicant is required to complete the following steps:
- The first step is to prepare an application for a duplicate and send it to the authorized body for registration.
- The application shall clearly state the reason for which the duplicate is being requested, for example, loss or damage.
- Please attach a receipt confirming payment of the state fee to the application.
- Furthermore, a written notice from the manufacturer shall be provided, which serves as proof that it is valid and necessary to issue a duplicate copy of the certificate.
- In the event that a duplicate is required due to damage, the original document shall be attached to the letter.
What is the Procedure for Obtaining a Duplicate?
Despite the fact that information about the registered equipment is stored in the database, the procedure for obtaining a duplicate is quite troublesome and time-consuming. Below is the general scheme of obtaining a copy of the registration certificate in our company.
At the initial stage, a preliminary examination of the documents pertaining to the medical equipment or device in question is carried out. Subsequently, the technical assignment is agreed upon and the schedule is approved according to which the registration procedures will be carried out.
The next step is to prepare a package of necessary documents, which includes submitting an application to the relevant authorized bodies. Once a duplicate of the registration certificate has been obtained, a declaration of device compliance with standards shall be issued.
Important Points when Obtaining a Duplicate Registration Certificate
The prepared package of documents as well as the application is submitted to the Authorized Body at the Ministry of Health of Russia in paper only. There is a possibility of both personal handover and sending the documentation by registered mail. However, it should be remembered that in case of sending by post, it must be sent with a notice of receipt of the letter, as well as with an of the enclosed documents package inventory.
A copy of the registration certificate is issued within seven days after the application has been submitted and the necessary documentation has been provided. The issued certificate shall bear the mark ‘duplicate, original is void’. The certificate shall be sent by post or handed in personally to the applicant. At the same time, the application for a duplicate is also kept at Roszdravnadzor.
What is the state duty for issuing a copy of the registration certificate?
The state duty for issuing a duplicate is provided for by Article 333.32.3 of the Tax Code of the Russian Federation and is 1,500 rubles. The amount of the duty is unchanged for both Russia and the EAEU.
As stated earlier, the validity of a registration certificate is indefinite, but for documents issued before the rules for state registration of medical devices came into force in 2013, there is a rule according to which certificates with a limited lifetime or registration certificates issued on the registration certificate ‘old form’ had to be replaced before January 1, 2021. At the same time, the replacement was carried out as quickly as possible, without conducting expert examinations. Please be advised that, regrettably, registration certificate that have not been replaced are now considered invalid.
How to Get a Duplicate Registration Certificate Quickly and Without Problems?
We would be grateful if you could contact us so that we can offer you our consulting assistance on existing issues. In addition, our specialists will be happy to provide comprehensive assistance at every stage of the process for obtaining copies of your registration documentation. We take full responsibility for our activities and are committed to finding solutions to any issues or situations that may arise.
Collaborating with MedReg Consulting is a mutually beneficial and rewarding experience. We adhere to a democratic pricing policy, offering all services at competitive rates. To ascertain the final cost of a particular service, we advise contacting the managers of the company, as the price is calculated based on a number of specific factors including the applicant’s requirements, the characteristics and features of the registered devices. Our company specialists will be happy to assist you and answer any questions you may have. You can contact us by the numbers indicated on the site or by ordering a callback. Further detailed information about all the services we provide can also be found on the website.