Changes in the legislation related to the Rules for Expert Examination of Medicinal Products and Medical Devices.
This is to inform you on the introduction of the updated version of Order No. 736 «On the Rules for Expert Examination of Medicinal Products and Medical Devices» dated November 18, 2009, covering the following points:
- The applicant shall provide 1 application and 1 registration dossier in the course of simultaneous submission of several to-be-examined modifications of a medical device belonging to the same type of medical devices and the same class of potential application risk, produced by the same manufacturer, differing in configuration changes and (or) technical parameters not affecting the operation and functionality. In case the submitted modifications belong to different classes of potential risk of application, a separate registration dossier shall be provided for each modification. (Chapter 2, item 8)
- Expert examination of medical devices consists of the following steps:
1) initial expert examination (registration dossier validation);
2) specialized expert examination;
3) laboratory testing of medical devices (except for medical devices which are apparatuses, instruments or equipment with component kits, accessories, consumables); (Chapter 3, paragraph 1, item 13)
- Laboratory testing is not carried out in the following cases:
- expert examination of medical devices which are apparatuses, instruments or equipment;
- expert examination of medical devices authorized to be marketed by regulatory authorities of the European Union countries, USA, Canada, Japan, Switzerland;
- re-registration of medical devices;
- accelerated expert examination of medical devices. (Chapter 3, paragraph 4, item 28)
Which factors also affect expert examination time frame:
- expert examination of medical devices (which do not require laboratory testing, regardless of class) is carried out within a period not exceeding ninety days, including:
initial expert examination (registration dossier validation) - ten calendar days;
specialized expert examination - seventy calendar days;
drawing up of an expert opinion on the safety, quality and efficiency - ten calendar days.
- accelerated expert examination for foreign manufacturers of medical devices is carried out within a period not exceeding twenty working days;
- accelerated expert examination of medical devices of domestic manufacturers is carried out within a period not exceeding five working days.
- If there is no possibility to carry out laboratory testing of samples of medical devices in the state expert organization's testing laboratory, such laboratory testing shall be carried out in the presence of the expert organization's representatives in a quality control laboratory of the manufacturer or in a contract laboratory used by the manufacturer in the following cases:
- the manufacturer's regulatory documentation establishes requirements for testing involving the use of the manufacturer's high-tech equipment and in-house quality control methods developed by the manufacturer (with respective justification provided by the manufacturer);
- the samples provided require special conditions of transportation.
If there is no possibility to carry out laboratory testing of medical devices under individual indicators, the expert organization's laboratory shall acknowledge the results of laboratory testing under individual indicators specified in the certificate (report) of analysis provided by the manufacturer. (Chapter 3, paragraph 4, item 32)
A number of amendments were also introduced to the registration dossier variation procedure
- Expert examination of the registration dossier variations is carried out with respect to medical devices during the registration certificate validity period. The applicant shall maintain relevance of the regulatory document on quality included in the registration dossier by timely introduction of amendments therein. (Chapter 5, item 43)
- The following documents shall be provided in addition to the registration dossier during expert examination of medical devices produced by manufacturers of the Republic of Kazakhstan on the basis of the transfer of production and technological processes:
- an extract from the contract or agreement between the domestic producer and foreign manufacturer for transfer of production and technological processes with the right to transfer technical documentation within the framework of such transfer;
- a report on the results of the transfer, including a description of the transfer steps, together with a list of the necessary production equipment;
- a report of the equipment run test provided by the transferor and transferee;
- environmental safety data (health and environment protection);
- a list of names of the documents on the manufacturing technology, standard operating procedures, quality manual;
- reports of clinical and pre-clinical studies of medical devices; clinical and laboratory testing provided by the transferor;
- toxicological, cytological, biological study and other test reports provided by the transferor. (Chapter 5, item 49)
* The local manufacturer shall in the course of full-scale transfer of production and technological process ensure full compliance of the production conditions and quality assurance system at the production site in the Republic of Kazakhstan with production conditions and quality assurance system at the production site outside of the Republic of Kazakhstan
We would also like to draw your attention to a new item of the Order covering accelerated expert examination.
Accelerated expert examination of medical devices is carried out in the following cases:
- prevention of emergency situations, emergence and elimination of epidemic consequences, infectious diseases pandemic;
- manufacture of medical devices in the conditions in line with ISO standard 13485:2016 and certified by international notified bodies, certified public accreditation bodies being members of the International Accreditation Forum (IAF) and who entered into an agreement with a competent authority of the Republic of Kazakhstan in the area of healthcare;
- availability of a notified body's document on full compliance of the medical device production and products quality control system with Directives of the European Commission on Medical Devices. (Chapter 5, item 50)
The form of application for registration dossier expert examination has also undergone certain changes. A mandatory item on MD modifications and accessories thereof was added.
The following changes and additions (the additions are in bold) were introduced in the list of documents to be provided for the registration and re-registration procedure execution:
- A list of documents certifying the registration in other countries, specifying the number and date of issue (if any) with an authentic translation into Russian
- A toxicological and hygienic testing report (protocol) with an authentic translation into Russian of testing results and findings with respect to medical devices and components in contact with the mucous membrane or skin
- A report of stability studies justifying the shelf life period established (for medical devices, including those related to sterile components), with an authentic translation into Russian of the results and findings
- Information about software (if available): software validation results, data on verification and initial expert examination thereof, including information about development and testing thereof at the production site and in the framework of multicenter studies, data on operating system identification and labeling.
- Description of medical devices packaging (information about packaging, including primary, secondary, group, transport, intermediate packaging; provide information (such as material, composition, size). Documents regulating medical device packaging materials quality (quality specification, primary packaging analysis certificate) with an authentic translation into Russian
- A photo (showing product, parts, and consumables appearance)
- Design and manufacture-related information: diagrams of production processes, the main stages of production, packaging, testing and finished product release procedures with an authentic translation into Russian
- Execution variants
Explanations or clarifications on issues arising during the expert examination period between the state expert organization and the applicant shall be provided by generating an electronic document protected by the applicant's individual password through the information system with a digital signature of the applicant and the state expert organization or through PHC on paper-based media.