We inform you that the Order of the Ministry of Health of the Republic of Kazakhstan dated November 18, 2009 No. 736 has lost its force by the Order of the Minister of Health of the Republic of Kazakhstan dated January 27, 2021 No. ҚР ДСМ-10 «On approval of the rules for conducting examination of medicines and medical devices».
In accordance with the updated legislation of the Republic of Kazakhstan, accelerated registration of medical devices is carried out only by decision of the authorized body in the field of health.
In cases where it is necessary to use MI to prevent emergencies, the occurrence and elimination of the consequences of an epidemic, a pandemic of infectious diseases — an accelerated examination is carried out within a period not exceeding 30 working days for all manufacturers, regardless of the country of manufacture.
Accelerated examination of medicinal products is carried out by decision of the authorized body in the field of health care (the Committee for Medical and Pharmaceutical Control or the Regional Health Department) and is carried out in the following cases:
- the purpose of the medicinal product for the prevention, treatment, diagnosis of rare diseases;
- prevention of emergencies, occurrence and elimination of the consequences of an epidemic, pandemic of infectious diseases.
Accelerated examination of a medicinal product is carried out within a period not exceeding 70 calendar days, including:
- initial examination — no more than twenty calendar days
- specialized examination — no more than forty calendar days
- formation of a conclusion on the safety, effectiveness and quality of the medicinal product, draft final documents of the examination of medicinal products — no more than 10 calendar days.
- Laboratory tests are not carried out during accelerated examination of medicines.
- Registration deadlines are indicated from the date of filing the registration application.
Accelerated registration and re-registration of medical equipment and drugs in the Republic of Kazakhstan
When conducting an accelerated procedure, the requirements for safety, quality and effectiveness of medicines are not reduced.
To conduct state registration of medicines or medical devices under the accelerated procedure, it is necessary to obtain confirmation letters from the Committee for Medical and Pharmaceutical Control or the Health Department of the region.
It is also important to take into account that the specified time frame does not include the time for replenishing the incompleteness of the registration dossier. Therefore, in order to pass the examination as quickly as possible, it is necessary to initially correctly collect the complete registration dossier.
Order a service for accelerated registration of medicines, drugs, equipment and products in the Republic of Kazakhstan
If you need accelerated registration of a medical device or medicine, Blitz Medica specialists will help you collect documents and submit an application as soon as possible. Our team has successful experience in accelerated registration of medical devices.
In May 2020, we registered the hardware and software screening diagnostic complex «APSDC» of Kazakhstani production, under the accelerated procedure.
The complex has several modules, including a thermal imaging module for measuring human body temperature, which in turn is included in the list of products subject to accelerated examination. APSDC was successfully registered.
Also, under the accelerated procedure, our team registered personal protective equipment and other medical devices.
Our team has successful experience in registering medicines and medical devices. We have received more than 380 registration certificates.
Thanks to our experience, we will collect the registration dossier in the shortest possible time and help to avoid errors when submitting an application, which in turn also affects the timing of registration of medicines and medical devices.
