Registration of medical equipment and medical devices
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Registration of Medical Equipment and Medical Devices: Medical Support
The period of our company's becoming a recognized partner in the medical business coincided with the period of professional growth for our team as well. Now we are the best experts and know how to obtain authorization documents for registration of medical equipment, medical devices and medicines in the territory of the Republic of Kazakhstan, Kyrgyzstan, Tajikistan and Uzbekistan.
From our working experience in this field we know that not all applicants are ready for establishing and maintaining relations with the public authorities directly engaged in the expertise activities for medical products of national and foreign manufacturers. The whole registration process takes a lot of efforts and time starting from a dossier preparation followed by amendments introduction including closing any comments at every expertise stage till its completion involving registration of medical devices or medical equipment in the state register.
The procedure for provision of documents for the state registration, re-registration and variation of the registration dossier (the master file)
- The state registration, re-registration and variation of the registration dossier (the master file) shall be performed on the basis of an application (either in paper or in electronic form) applied by an applicant to the state authority in compliance with Annexes 1, 2, 3 to the current Regulations.
- The following documents shall be attached to the application:
- a registration dossier with a list of documents annexed;
- samples of medical devices in the amount required for a triple analysis of those devices;
- standard samples
- a document confirming the payment of a registration fee.
- A list of documents included into the registration dossier shall be made depending on the safety class according to Annexes 4, 5 to the Regulations for the state registration, re-registration and type II variation (new registration) for medical devices and medical equipment, and according to Annex 10 to the Regulations for type I variations to the registration dossier.
- The documents in the registration dossier shall be authentically translated into Russian.
- An applicant shall pay for expert examination of a medical device and medical equipment under the state registration, re-registration and variation of a registration dossier to the expert organization on a full prepayment basis.
The procedure for expert examination of medical devices and medical equipment and variation of the registration dossier
- The expert examination of registration, re-registration and type II variations of the registration dossier specified in the State Registration Regulations shall consist of three stages:
- primary expertise;
- analytical expertise;
- specialized expertise for medical devices and medical equipment.
- The expertise examination of medical devices and medical equipment for type I variations specified in the State Registration Regulations shall consist of:
- primary expertise;
- specialized expertise for medical devices and medical equipment.
The procedure for expert examination of medical devices and medical equipment and its stages
- The expert organization shall upon acknowledging and registration of the application for expertise of medical devices and medical equipment in the course of the state registration and re-registration, within one business day publish the information about the application submitted on the Internet resource www.dari.kz (to the Information about the Expert Works Section).
- The applicant shall submit the documents and materials required for the expertise not later than seven business days upon such information publishing on the Internet resource.
- In case of the applicant's failure to submit the documents and materials within the period specified, the application shall be canceled (or removed from the program). The applicant can submit the application again.
- The expertise of medical devices and medical equipment in the course of the state registration, re-registration consists of the following stages:
- primary expertise
- analytical expertise (for medical devices)
- specialized expertise.
- In the course of expertise of a medical device containing a medicine pharmaceutical examination shall be conducted by a division of the expert organization. This division is responsible for the scientific specialized expertise of quality and safety of medicines, medical devices and medical equipment in the course of the state registration, re-registration and variation of the registration dossier.
- Every next stage of the expertise shall only be carried out upon successful completion of the previous stage.
- The expert organization shall be entitled to request the applicant's explanation or clarification for any specific items provided in the documents and materials of the registration dossier.
- Should the applicant fail to submit the materials requested within thirty consecutive days or substantiate in written form any other period for submission of the documents, but not longer than sixty consecutive days, the expert organization shall terminate the expertise and provide a negative opinion on safety, efficiency and quality.
- Within the period of the expertise the manufacturing conditions and quality assurance system shall be evaluated as decided by the state authority's resolution, as well as any pre-clinical and/or clinical studies shall be carried out by experts of the expert organization at the facilities of the manufacturer and pre-clinical and clinical centers.
- Clinical studies and/or trials of medical devices and medical equipment shall be carried out when there is a need to obtain any additional information on safety and efficiency in accredited clinical databases approved by the authorized body on the basis of the agreement concluded with the applicant.
- If there is no or insufficient data of preclinical (non-clinical) studies available, some additional studies shall be conducted by any organizations accredited to carry out pre-clinical studies approved by the authorized body on the basis of the agreement with concluded with the applicant.
- The expert organization shall when conducting expertise of medical devices and medical equipment, check the compliance of the specified safety class depending on the level of potential risk, human health and environmental damage, with the health care and technical regulations of the Republic of Kazakhstan.
- If the safety class differs from the one specified by the manufacturer the expert organization shall require the applicant to provide some additional materials to prove its safety.
- The expert organization shall upon completion of the expertise procedure generate one copy of the registration dossier including the following documents: a primary expertise report, a laboratory testing report, a specialized expertise report, a safety report, an approved operation manual for the medical device, an agreed quality and safety control regulatory document for the medical device with the reference number assigned, packaging layouts approved, labels, stickers, materials related to the correspondence with an applicant. The expert organization shall keep it in its archive.
- During the term of validity of the marketing authorization the registration dossier kept in the organization’s archive shall be supplemented with copies of marketing authorizations concerning the amendments to the applicant's documents attached.
- The registration dossier shall be kept in the archive in compliance with the confidentiality requirements regardless of the expertise results. After ten years of keeping registration dossiers for medical devices shall be destroyed.
- The expert organization shall determine the validity term of the marketing authorization: five years for a medical device, seven years for medical equipment.
- Medical devices and medical equipment shall after the expiry of the marketing authorization be re-registered.
- The applicant shall submit an application for re-registration of the medical device and medical equipment before the expiry date of the marketing authorization or within six months after the registration expiry.
Workflow for registration of medical equipment, medical devices and medicines:
- negotiations, the applicant’s request;
- conclusion of an agreement, submission of documents;
- approval of the work plan;
- generating a dossier according to regulations of the Order of the Ministry of Health of the Republic of Kazakhstan;
- submission of an application to the Pharmaceutical Control Department of Almaty city;
- stage-wise execution control during the expert works in the National Center of Medicines, Medical Devices and Medical Equipment Expertise of the Ministry of Health of the Republic of Kazakhstan:
- issuing of the marketing authorization to the applicant;
- issuing of the approved operation manuals for the medical device in the official and Russian languages