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PZN.Expert offers comprehensive services to confirm the location of medical products in Russia. We will help you to pass the procedure successfully, minimizing risks and shortening time of market entry. Fast, reliable.
Confirmation of the location of medical products in accordance with the Decree of the Government of the Russian Federation №719
Service stages to confirm the Russian origin of your products
• Analysis of the company profile and products for compliance with the requirements of Regulation 719.
• Evaluation of the possibility of concluding a special investment contract (if necessary).
• Definition of the list of production and technological operations necessary to confirm product localisation.
• Evaluation of the possibility of concluding a special investment contract (if necessary).
• Definition of the list of production and technological operations necessary to confirm product localisation.
Initial consultation
01
• Advice on the preparation of an application for inclusion in the register of Russian industrial products through the state information system of industry (GICE).
• Preparation of documents confirming compliance with the localization criteria according to the annex to Regulation 719.
• Advice on preparation and collection of documents for obtaining the certificate of expertise of the Chamber of Commerce and Industry (CCI) or the certificate of origin of products
• Preparation of documents confirming compliance with the localization criteria according to the annex to Regulation 719.
• Advice on preparation and collection of documents for obtaining the certificate of expertise of the Chamber of Commerce and Industry (CCI) or the certificate of origin of products
Preparation of documentation
02
• Consulting on preparing an application for inclusion of information in the registry of Russian industrial products through the state information system of industry (GISP).
• Preparation of documents confirming compliance with localization criteria according to the appendix to Resolution No. 719.
• Consulting on the preparation and collection of documents for obtaining an examination report from the Chamber of Commerce and Industry (CCI) or a certificate of product origin.
• Preparation of documents confirming compliance with localization criteria according to the appendix to Resolution No. 719.
• Consulting on the preparation and collection of documents for obtaining an examination report from the Chamber of Commerce and Industry (CCI) or a certificate of product origin.
Submission of an application to GISP
03
• Support in interacting with the CCI to obtain an examination report confirming compliance with the requirements of the resolution.
• Consulting on preparing for an on-site inspection by the CCI (if required).
• Consulting on preparing for an on-site inspection by the CCI (if required).
Expert supervision
04
• Supervision of the process of obtaining the certificate of expertise or the certificate of origin of the goods.
• Updating of the register data in the GICE and control of the entry of information into the register.
• Updating of the register data in the GICE and control of the entry of information into the register.
Receipt of the conclusion
05
• Advice on making changes to the registry record in case of changes in production operations or localization indicators.
• Accompanying the visits of the Ministry of Industry and CCI as necessary.
• Accompanying the visits of the Ministry of Industry and CCI as necessary.
Follow-up of inspections
06
Answers to frequently asked questions
What is localization confirmation?
Confirmation of localization of medical devices is a procedure that verifies that a significant part of the production of a medical device is carried out on the territory of the Russian Federation. This requirement was introduced by Russian Government Resolution No. 719 and aims to support domestic manufacturers and ensure the safety of medical products on the Russian market.
Which medical products are subject to confirmation of localization?
All medical products that are subject to the RF Government Decree 719 and included in the relevant lists are subject to confirmation of localisation. The exact list of products can change, so it is recommended to check current information with regulatory bodies or our specialists.
What is the time frame for the procedure?
The time to confirm the location may vary depending on the complexity of the product, the amount of documentation provided and other factors. On average, the process takes from a few weeks to several months. However, our company strives to minimize deadlines through experience and efficient work organization.
What are the risks associated with not confirming the location?
Failure to confirm the location of a medical device can lead to the following negative consequences:
Impossibility of registration of medical products in Russia and, accordingly, prohibition of its circulation on the territory of the country.
Imposition of administrative fines on legal and natural persons who violate the law.
Loss of competitive advantage in the Russian market, as many state and commercial organizations give preference to domestically produced products.
Risk to the company’s reputation due to non-compliance with legislation.
Impossibility of registration of medical products in Russia and, accordingly, prohibition of its circulation on the territory of the country.
Imposition of administrative fines on legal and natural persons who violate the law.
Loss of competitive advantage in the Russian market, as many state and commercial organizations give preference to domestically produced products.
Risk to the company’s reputation due to non-compliance with legislation.
How do I calculate the cost of the service?
The cost of the service depends on the complexity of the project, the volume of documentation and other factors. We offer individual cost calculation for each client.
What documents do I need to submit to start working?
The list of required documents depends on the type of medical device and its stage of production. Detailed list will be provided by our specialist after initial consultation.
How can I be sure that my information is confidential?
We guarantee full confidentiality of all information provided by the client. All work is carried out in accordance with the current legislation on personal data protection. In addition, PKN.Expert uses a reliable server for data storage, which ensures high level of security and preservation of important information.
Other services within the development of medical devices
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