During the procedure, the quality of the devices and their compliance with current norms and standards are inspected. Only truly high-quality and efficient medical devices successfully pass all checks and are included in the register
Medical devices manufactured in the RK and imported to its territory are subject to registration including the following:
Only those devices are not subject to the state registration that are manufactured under individual orders and do not go on free sale
You will have a lot of work, the nuances of which are unknown to you:
The procedure may take a long time
You may not know the details of the regulatory environment
You may not know the nuances of communication in regulatory bodies or in the country
We will undertake all the routine work.
You save time and therefore money
We have a team of professionals in different areas of regulatory affairs
We select individual solutions for each project
We guarantee confidentiality
We guarantee that we provide a complete and highly qualified assistance and that we meet the timing and control requirements of the process
List of services
Consulting
Adding changes to the registration certificate
Adding changes to the registration dossier
Preparation and collection of the registration dossier
Development and analysis of technical documentation
Collaboration with testing centers
Interaction with registration bodies
Organization of factor of production assessment
Obtaining official letters from the state body on the pertaining of the product to medical products
Registration stages
According to the current rules in the Republic of Kazakhstan, the registration of medical devices includes the following stages:
Collection of the dossier and receipt of samples
Signing an agreement with the state body
Primary expert examination, which assesses the completeness, contents, and accuracy of the paperwork submitted by the applicant in the registration dossier
Analytical expert examination, including the testing of medical devices samples and determination of the reproducibility of analytical procedures
Inspection of manufacturing of medical devices
Specialized expert examination, which is implemented by studying the documents of the registration dossier for safety, effectiveness, and quality of medical devices
Safety statement, which generates a summary report on the safety, effectiveness, and quality of the medical device
Assigning a registration number and issuing a registration certificate for the medical devices
Service cost
State license fee
The final cost and terms will be calculated at your request
Questions and Answers
1. How is the document calculated?
Documents are calculated in characters. One page equals 1800 characters with spaces.
1. Why do medical devices undergo testing?
1. Is it possible to suspend or revoke the registration certificate of a medicine?
2. What is the period of registration of a medicine?
3. When is it not possible to conduct clinical or preclinical trials?
1. List of documents required for registration
1. Which documents are required to obtain an import license for medical equipment in Kazakhstan?
1. Which documents are required to obtain a license for medical and pharmaceutical activity in Kazakhstan?
1. List of documents required for registration
1. Which documents are required for registration?
1. Which documents must be submitted to obtain a certificate of approval of the type of measuring instruments in Kazakhstan?
1. Which documents must be submitted to obtain a certificate of conformity for products in Kazakhstan?
1. Which documents on the status of pharmacovigilance activities are required to be submitted?
1) List of the principal data on the medicine of the product license holder
2) Master-file of the pharmacovigilance system (after signing a contract)
2. Are illustrations, images and graphics included in the calculation of a document?
Graphic illustrations are not included in the calculation if there is no text on them that needs translation.
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