Dear colleagues and group members,
In October 2017 my usual newsletter will focus on updates in developing harmonised Eurasian medical device regulatory system.
- Eurasian Quality Management System Requirements for Medical Device Manufacturers
In early October 2017, the Eurasian Commission published decision 134 (link in Russian), which includes what is requirements for a quality management system (QMS) for manufacturers of medical devices.
This decision is the last of the “second level” documents approved in the harmonised Eurasian model.
According to the published regulation, the implementation, development and maintenance of the QMS is becoming mandatory for the registration of sterile IIA, IIB, III class devices. For low class devices (I and non-sterile IIA class products) QMS maintenance is not formally mandatory,however, it offers the advantage of a simplified amendment/re-registration procedure (notification instead of assessment).
The document contains checklists with requirements for every QMS subsystem: design and development controls, record/document change control, corrective and preventive actions, production and process control and consumer-related processes.
The assessment of the QMS is a mandatory step in the registration process and is carried out by way of an inspection audit of every declared manufacturing site by accredited organisations of Eurasian member states (according to the document, there is a list of accredited organisations maintained by the regulator of each member state, and the manufacturer may apply to any of them).
In addition to the primary “registration” inspection audit periodic post-registration QMS assessment inspections are also requited once every three years, as well as unscheduled inspections in limited cases.
The document introduces a twelve-month transitional period, during which QMS assessment is not mandatory for the registration. During this period, the submission of an ISO 13485 certificate provides a presumption of conformity with quality requirements when the QMS inspection audit is postponed (within a two-year period after registration).
- Russian Laboratories are Preparing to Start Medical Device Testing According to Harmonised Eurasian Requirements
In early October 2017, the Russian medical device expert centre (VNIIMT (ВНИИМТ) published information about its inclusion in the list of organisations accredited for technical and biological testing for the registration of medical devices according to the Eurasian procedure.
Later, on 27 October, during the seminar on Eurasian medical device testing requirements held by the same organisation, it was confirmed that manufacturers may apply for start testing according to the new requirements.
At the end of October 2017, there are two laboratories accredited for testing according to Eurasian requirements. The list is published on the website of the Russian medical device regulator Roszdravnadzor.
It should be noted that the Eurasian medical device regulation model contains separate requirements for technical (link in Russian) and biological safety (link in Russian) testing, which must be conducted in an accredited laboratory in any Eurasian member state.
- Eurasian Advisory Committee on Medical Devices
Another document adopted by the Eurasian commission in October is decision 123 (link in Russian) “On the Regulations on the Advisory Committee on Medical Products”. According to the text in the published document the Advisory Committee is a new regulatory body on the Eurasian level which will be responsible for adjusting differences between Eurasian member states (i.e., the reference state and acceptance state) during the process of medical device registration assessment. The committee’s tasks also include consultations on issues in the field of medical devices.
Thank you for following this blog! My objective here is to make developing Eurasian medical device regulations clearer. You can also follow my updates on Twitter @MedDevRus.