The National Center for Expertise of Medicines and Medical Devices (NDDA), Kazakhstan’s body responsible for the assessment of quality and safety of medical devices, has published an official notice on the rules for inspections with regard to medical devices.
New Rules for Inspections: Key Points
According to the newly adopted medical device inspection rules, an expert organization shall inform the medical device manufacturer about the inspection in advance. The whole process should take up to 120 calendar days starting from the date the medical device manufacturer was initially notified about the upcoming inspection. However, the time necessary to organize and conduct the inspection should not be included in the general medical device examination timeframe calculation.
The new medical device inspection rules prescribe that the manufacturer shall submit the following documents:
- The letter of consent with regard to the inspection to be conducted, also with the indication of the planned terms,
- Quality guidelines,
- Dossier of the manufacturing facilities (if applicable),
- The list of medical devices already being manufactured or planned to be manufactured on the facilities in question,
- A copy of the last facility inspection report (if already exists),
- A copy of the audit report with regard to the Quality Management System (if already exists).
All documents listed here above should be submitted in electronic format no later than 30 calendar days from the date of the initial request. The documents issued in a foreign language should be translated into Kazakh or Russian.
An expert organization would review the submission within 15 calendar days. Upon completion, an expert organization would form a schedule of inspections and notify the applicants accordingly.
In the course of the inspection itself, the medical device manufacturer should provide a dedicated employee member to assist the inspection team, and also provide the translation of the information requested in Kazakh or Russian.
According to the new rules, the member of the inspection team would act in accordance with the requirements set forth by the applicable international standard – ISO 13485 – or its national or regional equivalent.
The whole inspection process would take place as follows:
- Each day the inspection team leader would discuss the non-compliances identified with other team members,
- Upon completion of a final meeting with the responsible representatives of the medical device manufacturer, the inspection should be deemed completed, and the inspection team leader shall inform all parties involved about the results.
In case if the non-compliances identified during the inspection of manufacturing facilities are critical, the inspection team leader shall issue an appropriate protocol and notify the state authorities for the appropriate measures to be taken. There should be two samples of the protocol for each party respectively.
The final inspection report describing its results should be formed within 30 days upon its completion.
Medical Device Inspection Rules: General Provisions
The new rules adopted recently in Kazakhstan describe in detail the way the inspections of manufacturing facilities should be carried out. According to the document, in the course of the medical device inspection, an inspection team consisting of the specialists of an expert organization should visit the manufacturing facilities. The scope of the inspection covers the manufacturing facilities conducting both complete or incomplete (packaging, labeling) manufacturing cycles.
An inspection should be carried out in the context of expertise required for the purpose of the state registration, re-registration of medical devices, changes to the registration dossier of a medical device, and also in the course of continuous monitoring of safety, quality, and effectiveness of medical devices.
According to the new rules, the following types of inspections could take place:
- Initial inspection to be carried out (a) in the course of examination of Class 2a (sterile), 2b, and 3 medical devices that haven’t been registered in the Republic of Kazakhstan before; and (b) prior to, in the course of, and also upon completion of clinical trials with regard to the Class 2b, 3, and also implantable medical devices.
- Periodic (planned) inspection of manufacturing facilities that have already been subject to the initial inspection. The inspection of such type should be conducted once in 3 years in order to verify the effectiveness of the Quality Management System employed by the medical device manufacturer.
- Extraordinary inspection to be conducted (a) when making changes to the registration dossier of a medical device in terms of manufacturing facilities, or (b) in order to confirm the fact that all non-compliances identified in the course of the previous inspection were duly repealed, or (c) in the course of investigations, related to the safety and effectiveness of medical devices, or (d) in order to confirm that the reasons leading to manufacturing of low-quality medical devices were repealed.
All expenses arising from the inspection should be incurred by the applicant.
Medical Device Inspection Procedure
The new rules prescribe the particular way the inspection should be conducted by an expert organization.
According to the rules, an inspection team should consist of the leading expert (team leader), inspectors, engaged experts, and trainees. In general, an inspection team should meet the appropriate requirements set forth by the international standard ISO 13485 in terms of the number and qualification of its members. It is also important to mention that the trainees included in the inspection team are not allowed to participate in the classification of non-compliances identified in the course of the inspection. The inspection team could be also accompanied by observers and translators – if necessary. In the course of the inspection, the experts should not provide consultations. They should be also bound by the confidentiality requirements with regard to the information they have access to in the context of the inspection.
The duration of the inspection of one manufacturing facility depends on the scope of work to be conducted, and also on the type and complexity of the manufacturing facility subject to inspection.
Prior to the commencement of the inspection, an inspection team shall study the documents provided by the medical device manufacturer, describing the activity and facilities to be inspected. Should some part of the manufacturing process be outsourced to a third party, such a third party should be also subject to inspection.
The initial inspection program could be subject to changes in case of identifying the non-compliances resulting in high risk with regard to the quality of the products, the processes, or the Quality Management System.
Specific Rules and Procedures
The present document also provides certain rules and procedures to be applied in specific cases. For instance, according to the rules, an expert organization is entitled to carry out an inspection of foreign manufacturing facilities in a remote format (by the means of video- and audio conferencing) in the following cases:
- Reasonable risks associated with spreading the infection,
- Illnesses and injuries caused due to the impact of negative factors of chemical, biological and radioactive nature.
Should the results of a remote inspection be positive, an actual on-site inspection should be carried out within one year from the date the restrictions would be up-lifted.
Summarizing the information provided here above, the new rules adopted recently in Kazakhstan describe in detail the way the inspections of medical device manufacturing facilities should be conducted. In particular, the rules prescribe the actions to be conducted by each of the parties participating in the process.
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