To obtain the marketing authorisation after the first submittal , it's necessary to prepare for it in advance and thoroughly.
It's possible to obtain the marketing authorisation after the first submittal only if there is well-organisaed and coordinated cooperation between you and the company whose services you use.
In other words, to achieve the positive result, you need to prepare for the beginning of the registration procedure.
This article briefly and fully describes the procedure of registration of medical products and provides practical recommendations which will help you significantly reduce financial expenses and to optimise the tern of the procedure itself.
It's well-known, that only those medical products which have marketing authorisation may be utilized in Russia.
To issue the permits for medical products, it's necessary to apply to Roszdravnadzor. This service registers medical products and issues the marketing authorisation after successful passing of all stages required for obtainment of permits.
Procedure of Registration of Medical Products in Accordance with Russian Legislation
- Filling in the application form for registration of a medical product before its submittal to RZN with the documents and samples of the medical product required for the beginning of the registration process
- After this information gets to RZN, the assessment of the submitted documents carried out by members of this state authority begins
- The next stage is sending of tasks to expert facilities authorised by RZN for carrying out of quality and safety assessment of products
- Then the clinical assessment of the product submitted for registration is conducted
- As a result of clinical trials, the II stage of assessment of efficiency of application of the medical product is carried out
- At the last stage, RZN notifies the applicant either about the positive resolution about registration of the product in the state register with obtainment of the marketing authorisation, or about denial of registration.
Also the procedure of registration of medical products may include other events depending on the type of the procedure .
Recommendations for the Manufacturers of Medical Products Obtaining the Marketing Authorisation
- You should collect documentation with maximum thoroughness during the first stage. everything is important, even commas and periods
- Ensure you have all the documentation and certificates required for obtainment of the marketing authorisation
- To avoid losses of valuable time for correction of mistakes in the documents submitted to RZN, apply to competent specialists in medical and technical translations
- If there are foreign language documents, order notarized translation
- Use the services of only competent experts in registration of medical products whose practical experience will allow you to obtain the marketing authorisation easily after the first submittal
- If necessary, consult the specialists in this area. Consulting services in the area of registration of medical products are very popular in the market nowadays. A competent specialist may quickly tell and explain all of the most important aspects and nuances of all stages of registration. To get answers for the most pressing answers, you may order offsite consultations , which will allow you to find out all the necessary information. The skilled specialists will always give you a good advice concerning the right actions in any situation
- Correctly prepared documentation kit is the basic premise for passing the Roszdravnadzor primary documentation review stage
- Be ready to be requested to provide additional information during the stage of clinical trials .
Hence, before starting the registration procedure, you have to be prepared if you wish to receive a positive resolution of RZN and obtain the endlessly valuable and important document — the marketing authorisation for a medical product.