On 01.01.2021, the RF Government Resolution No. 982 dated 04.07.2020 on the cancellation of mandatory declaration of medical devices for manufacturers came into force. And now the procedure for execution of the Declaration of Conformity is a voluntary procedure.
This document will facilitate business expansion and enable the acquisition of additional benefits. Furthermore, the single quality mark allows products to be labelled with a single quality mark.
What is Included in the Declaration Process?
- Collection of the required package of documents.
- Selection of samples for testing (study).
- Verification of medical devices for compliance with international standards and internal GOSTs.
- Conducting testings (studies).
- Collection of documents.
- Submitting the application to the certification center.
- If necessary, a visit to the production site is carried out.
- Analysis of the received data and decision-making on issuing a Declaration of Conformity.
- Issuance of a certification document.
Specifics of the Procedure
First and foremost, it is essential to conduct specific tests to verify compliance. This can only be done by accredited laboratory centers. Once all the declared medical equipment has been verified as compliant with the relevant requirements, the study reports can be finalized. These are attached to the application.
It is important to understand that all documents are filled out in the order established by legislators. It is necessary to comply with the current rules and recommendations.
Types of Voluntary Certification
- One of the most common types in the Russian Federation is voluntary certification of products in the GOST R system. In this case, certification is performed in accordance with the requirements of one of the GOSTs.
- Another type of certification involves the preliminary introduction of ISO standards at the enterprise. This standard gives the opportunity to enter the international market, increases the confidence of customers, organizations and the state.
Conformity Marks
In case of a favorable decision to issue a certificate for a medical device, a conformity mark depending on the type of certification chosen is applied to the packaging:
Mark of conformity to technical regulations of the Russian Federation in case of voluntary certification
Customs Union conformity mark
Certification Validity Period
- There is no limit on a single import of one batch.
- For serial deliveries and production of goods it is up to 3 years.
Extension is not provided; upon expiration of the validity period, the certification procedure shall be repeated.
Advantages of Preparation a Declaration of Conformity with the Help of MedReg Consulting Company
- Our specialists are fully conversant with all aspects of the process.
- Ensuring the correct completion and execution of all necessary documentation.
- Maintaining obligatory control over the conduct of studies. Should any errors be identified during the preparation process, our specialists will assist in implementing the necessary updates promptly.
- Submitting the relevant documents to an appropriate center.
- Upon completion of the declaration, it will be delivered to the customer.
We would like to take this opportunity to recommend our company as a reliable provider of certification documents or re-issuer of certificates of conformity. This allows avoiding significant inconvenience and delays for customer. We are on hand to assist with the certification process for medical devices and can provide a range of legal services to help you pass your medical devices conformity verification. You can therefore rely on us to complete any task to a high standard and in a timely manner.