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During the life cycle of a medical device, situations may arise that require changes to registration documents - this is a mandatory procedure. Changes to the registration certificate and medical device registration file maintain the validity of the registration documentation and ensure the safety and effectiveness of medical devices.
Amendment of registration certificate and record
Назад
Our company will help you quickly and qualitatively to process all necessary documents and pass the procedure of registration.
What it is and why
Назад
Changes will be required when:
- reorganization of the legal entity or change of name and address;
- modification of the product characteristics (change in structure, composition of materials, principle of operation, technical characteristics, etc.);
- change of storage and transport conditions (requirements for packaging, marking, temperature etc.);
- change of production conditions (change of production sites, equipment, production technology);
- change of regulatory framework (entry into force of new or modification of existing regulatory documents regulating the production and circulation of medical products).
- reorganization of the legal entity or change of name and address;
- modification of the product characteristics (change in structure, composition of materials, principle of operation, technical characteristics, etc.);
- change of storage and transport conditions (requirements for packaging, marking, temperature etc.);
- change of production conditions (change of production sites, equipment, production technology);
- change of regulatory framework (entry into force of new or modification of existing regulatory documents regulating the production and circulation of medical products).
- Untimely submission of significant changes to registration documents may lead to the withdrawal of the registration certificate.
Simplified registration procedure
The manufacture and sale of medical products with invalid equipment is illegal. Fines can be imposed on the legal entity and officials, and disclosure of violations may have a negative impact on the reputation of the company.
- For minor changes that do not affect the safety and effectiveness of a medical device, a simplified registration procedure is applied. For example, reorganization of the legal entity or change of name, change of product labeling, packaging, adjustment of technical documentation without changing the characteristics of the product.
Full registration procedure
- In the case of significant changes requiring additional research and expertise, registration shall be carried out according to the full procedure.
VIRD/VIRU process
Interaction when making changes to the medical device registration certificate
The customer provides information on planned changes and necessary documents (if available). Our experts help to determine the type of procedure and make an application in Russia.
Interaction when making changes to the medical device registration certificate
01
Experts prepare a complete package of documents for filing an application for changes, write a description of all the corrections that are required to be entered in the registration file, prepare the missing documents based on your information.
Preparation of documents
02
The completed package of documents is sent to Roszdravnosti in electronic or paper form. If necessary, we provide the registration authority with additional information and documents.
Filing and consideration of application
03
We inform the customer about the approved solution. The manufacturer or distributor receives a new registration certificate and makes changes to meet new requirements if necessary.
Making changes and obtaining the registration certificate
04
Let our experienced team of experts make changes to the registration documents. We guarantee professional approach, compliance with all regulatory requirements and successful completion of the procedure.
Our capabilities and competencies
Highly qualified staff with professional education
The company’s staff consists only of specialists with specialized education in the fields of chemistry, biology, chemical technology, biotechnology, microbiology, biochemistry and biomedical engineering and specialists with experience in the field of registration of medical products.
Cooperation with relevant organizations and regulators
We cooperate with leading specialized universities, medical organizations and manufacturing enterprises. Our office is located 10 minutes from the Russian Surveillance, we have established cooperation with all authorities of the regulator.
Reliable data protection
The company uses a reliable server for data storage, which ensures high level of security and preservation of important information.
Leave this process to the professionals
Medical product registration is a complex and multi-step process requiring in-depth knowledge of legislation, technical regulations and standards.
m. Kropotkinskaya
Moscow, Voekhonka Street, 15
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