Хотела бы ответить на Ваше письмо п

Хотела бы ответить на Ваше письмо по моментам регистрации.
1) Нам необходимо собрать регистрационное досье (сформировать регистрационное заявление, согласовать формулировки продуктов, которые войдут в регистрационный сертификат, получить от вас все необходимые нотариально заверенные документы, образцы продуктов). То есть чем быстрее мы все получим от Вас, тем быстрее мы выйдем на регистрацию.
2) Государственная регистрация осуществляется в срок, не превышающий 50 рабочих дней со дня принятия решения о государственной регистрации медицинских изделий. Но срок проведения клинических испытаний в этот срок не включается. При получении разрешения на проведение клинических испытаний регистрация приостанавливается. Скорость на данном этапе будет зависеть от скорости предоставления образцов, набора пациентов, а также будет зависеть от того, как вы будете предоставлять отчеты о предоставлении клинических испытаний.

Результаты (английский) 1:

Would like to respond to your letter in the registration points.1) we need to assemble a dossier (form registration statement, agree on the wording of the products, which will be included in the registration certificate, obtain from you all necessary notarized documents, product samples). That is, the sooner we all get from you, the faster we will come to the registration.2) State registration is effected within the term not exceeding 50 working days from the date of adoption of the decision on the State registration of medical products. But clinical trials not be included in the period. Upon receipt of authorization to conduct a clinical trial registration is suspended. Speed at this stage will depend on the speed of samples, a set of patients and will also depend on how you will provide reports on the provision of clinical trials.

Результаты (английский) 2:

I would like to respond to your letter of the date of registration.
1) We need to collect the registration dossier (registration application form, agree on the wording of the products to be included in the registration certificate, to receive from you all the necessary notarized documents, product samples). That is, the sooner we get from you, the faster we will go for registration.
2) State registration is carried out in a period not exceeding 50 working days from the date of the decision on the state registration of medical devices. But the duration of the clinical trials in this period is not included. Upon receiving permission to conduct clinical trials of registration is suspended. The rate at this stage will depend on the speed of the samples, a set of patients, and will also depend on how you will provide reports for clinical trials.

Результаты (английский) 3:

would like to respond to your letter on points registration.
1) we need to collect the registration dossier (a registration statement, agree on language productswho will enter the registration certificate, get you all necessary notarized documents, samples of products). so the sooner we get from you, the sooner we get to the registration.(2) the public registration is performed in a period not to exceed 50 working days from the date of adoption of the decision on the registration of medical products.but the duration of the clinical trials in this period is not included. in obtaining permission to conduct clinical trials registration is suspended.the speed of this phase will depend on the speed of providing samples of patients, but also will depend on how you will provide reports for clinical trials.