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Since January 27, 2021, the Order of the Minister of Health of the Republic of Kazakhstan No. 736 "On Approval of the Rules for the Examination of Medicines and Medical Devices" has become invalid»
Dear colleagues and partners!
MedExpert company informs that since January 27, 2021, the Order of the Minister of Healthcare of the Republic of Kazakhstan No. 736 "On approval of the Regulations of examination of medicinal products and medical devices" became invalid, and a new Order of the Minister of Healthcare of the Republic of Kazakhstan No. KR DSM-10 "On approval of the Regulations of examination of medicinal products and medical devices" became effective.
The main changes to Order No. KR DSM-10 are as follows:
1. A deadline has been set for the rejection of an application for an expert appraisal by the ASC officer. Within two working days he shall notify about non-acceptance of the application for the expertise if the application is not submitted with a complete set of documents;
2. Details of the specialized examination stage, namely the analysis of the documentation requested in the registration dossier;
3. One of the conditions for not carrying out laboratory tests was a document from a notified body that the manufacture of the medical device and its quality management system fully complies with the requirements of the European Commission's Medical Device Directives;
4. Accelerated expertise is now only possible for the prevention of emergencies of epidemics, pandemics, and infectious diseases. ISO 13485, as well as the EC certificate, no longer allows the registration or re-registration procedure to be started with accelerated expertise;
5. In the application form for the examination of a medical device, the section 'Type of Examination' has been added, the full designations of the type of constituent parts in the variants have been added, and the types of MD, MT, and IVD MD are described in more detail.
Thus, Order No. KR DSM-10 of the Minister of Healthcare of the Republic of Kazakhstan "On Approval of the Regulations of Expertise of Medicinal Products and Medical Devices" is an improved version of Order No. 736 and provides more detailed information on the rules of the expertise.
MedExpert guarantees complete support of the client from the beginning to the end of the registration certificate procedure, including the expertise described in this Order No. KR DSM-10.
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