Expedited medical device expertise
Amendments and changes to Order No.736 of the Minister of Health dated November 18, 2009 «On the Rules for Expert Examination of Medicinal Products and Medical Devices».
The amendments cover the following items:
1. 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, paragraph 8)
2. 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 devices, instruments or equipment with component kits, accessories, consumables); (Chapter 3, paragraph 1, item 13)
3. Laboratory testing is not carried out in the following cases:
- expert examination of medical devices which are apparatuses, appliances or equipment;
- expert examination of medical devices authorized to be marketed by regulatory authorities in the European Union, 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 timing:
- expert examination of medical devices (which do not require laboratory tests, 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 days;
drawing up 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.
4. If there is no possibility to carry out laboratory tests of samples of medical devices in a test laboratory of the state expert organization, laboratory tests shall be carried out in the presence of representatives of an expert organization in the quality control laboratory of the manufacturer or in a contract laboratory used by the manufacturer in the following cases:
- normative documentation of the manufacturer establishes requirements for tests involving the use of high-tech equipment of the manufacturer 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 is no possibility to carry out laboratory tests of medical devices under individual indicators, the laboratory of the expert organization shall acknowledge the results of laboratory tests under individual indicators specified in the certificate (report) of analysis provided by the manufacturer. (Chapter 3, paragraph 4, item 32)
Amendments were also introduced to the registration dossier variation procedure
5. Expert examination of registration dossier variations is carried out with respect to medical devices during the registration certificate validity period. The applicant shall maintain relevance of the normative document on quality presented in the registration dossier by timely introduction of amendments therein. (Chapter 5, paragraph 43)
6. 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, paragraph 49)
* The local manufacturer shall in the course of full 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 paragraph of the order on 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 accordance with ISO standard (ISO) 13485:2016 and certified by international notified bodies, accredited public accreditation bodies being members of the International Accreditation Forum (IAF) and who entered into an agreement with the competent authority of the Republic of Kazakhstan in the area of healthcare;
- availability of a notified body's document on full compliance of the production of the medical device and products quality control system with Directives the European Commission on Medical Devices. (Chapter 5, paragraph 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:
1) 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
2) A toxicological and hygienic tests report (protocol) with an authentic translation into Russian of tests results and findings for medical devices and components in contact with the mucous membrane or with the skin
3) A report of stability studies justifying the shelf life period (for medical devices, including those related to sterile components), with an authentic translation into Russian of the results and findings
4) Information about software (if available): the results of software validation, data on its verification and initial expert examination, 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.
5) Description of medical devices packaging (information about packaging, including primary, secondary, group, transport, intermediate packaging; provide information (such as material, composition, size) Documents regulating the medical device packaging materials quality (quality specification, primary packaging analysis certificate) with an authentic translation into Russian
6) Photos (showing product, parts, and consumables appearance)
7) 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
8) Execution variants
Explanations or clarifications on issues arising during 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.
The draft changes and amendments to the Order have not yet entered into force and are being considered by the Minister of Health of the Republic of Kazakhstan.