Russia implements compulsory for medical device registration management regulation, mainly by the Russian federal supervision bureau (Roszdravnadzor) is responsible for http://www.wiselinkchina.com/. Medical device registration is divided into two types: registration certificate and registration statement.
Certificate of registration
The registration certificate is a mandatory audit and registration procedure for high-risk medical devices, medium and high risk medical devices and certain low-risk medical devices. After obtaining the registration certificate, they are allowed to be sold and used in Russia. Documents required for registration include medical device design, technical documents, product labels and instructions, product manufacturing qualifications and clinical test reports. The registration statement applies to low-risk medical devices and does not require a Russian registration certificate. However, the applicant will need to submit legal documentation and ensure that the product complies with relevant Russian standards and regulations.
Russian device registration process
Determining the classification and grade of medical devices;
Submit the application for certification and registration, submit risk analysis documents, technical documents, test reports and other relevant materials;
Preliminary audit by Russian certification authority, including sample testing and production site inspection;
Obtain the registration certificate, including the technical parameters of medical devices, certification standards, registration certificate number and other information;
During the validity period of the registration certificate, the annual inspection and report update should be carried out.
Specifically, the detailed process for certification registration of medical devices may vary from product to product and from certifying body to certifying body. Enterprises must comply with relevant regulations and procedures when conducting certification registration for medical devices to ensure that products meet requirements and obtain certification certificates.
Russian device registration cycle
Russian national standards for medical device certification registration time does not have clear provisions, the length of the audit cycle depends on the efficiency of each audit institutions and the integrity and accuracy of the application enterprise submitted documents.
Usually, the cycle of medical device certification registration needs 3-6 months, the specific time may also vary depending on the type and complexity of medical devices, the efficiency of the Russian certification body and the audit process.
During the audit period, the audit institution will carry out on-site inspection, sample testing, technical document review and other activities. If the agency finds that the documentation is incomplete or does not meet the requirements, it requires the applicant and the manufacturer to make corrections and corrections within a specified period, a process that may add time to certification.
Therefore, before preparing for the registration of medical device certification, enterprises should arrange time in advance, actively communicate with certification bodies and relevant partners, improve materials and rectify defects through the guidance of professional consulting bodies or personnel, ensure that the submitted documents are complete and accurate, and obtain the certification certificate in the shortest time.
Scope of Russian import control
Certification requirements: All imported medical devices must pass the Russian medical device registration certification, obtain the certification certificate and record in the Russian national medical device registration directory.
Tariffs: Russia imposes tariffs on imported medical devices. The tax standard is determined by the path and calculation formula, and the specific charging standard will vary according to different products, quantities and import sources.
Quality control: Imported medical devices must meet Russian standards and regulations, including specifications, weight, marking, packaging and other requirements.
Access requirements: Import of medical devices can only be carried out after obtaining import license from Russia. If the importer and producer are the same company, then the company also needs to apply for a special license and pay the corresponding fee.
It is important to note that there may also be specific controls for different products. For example, Russia may impose additional control measures on the import of certain more dangerous or controversial medical devices, such as quantity restrictions or requirements for specific import control procedures. Before importing medical devices, enterprises are advised to first understand the specific control requirements and procedures to ensure that the import is legal and smooth.
Post time: May-29-2023