WHO and IVD products

In Roszdravnadzor the seminar for domestic producers on the questions of the pre-qualification requirements of WHO to medical products for invitro diagnostics has taken place.

On June 15, 2016 in Roszdravnadzor under the chairmanship of the head of Service Mikhail Murashko the seminar on the questions of the pre-qualification requirements of WHO to medical products for invitro diagnostics took place.

As the main speakers of the action Irena Pratt -the team leader for pre-qualification assessment department VED and WHO medical products and Robin Myurant – Technical Officer Department of pre-qualification team VED and WHO medical products made a speech.

The seminar was also attended by the representatives of the Ministry of Health of Russia, the Russian Association of manufacturers and suppliers of medicinal products, medical devices and equipment, Roszdravnadzor, RZN subordinate organizations and the Association of clinical laboratory diagnostics producers and domestic manufacturers of medical devices for the invitro diagnosis.

The meeting covered the issues of the dossier evaluation system of medical products, inspections and also laboratory quality assessment of medical devices for the diagnosis of invitro. Particular attention was paid to the diagnosis of HIV, hepatitis B and C and malaria.

Domestic producers were able to get acquainted with the manuals and documentation required to pass the products prequalification.

The opportunity of participation in such WHO programs will allow the domestic producers to increase the share of exports of competitive medical devices for the diagnosis of invitro by the foreign markets and to conform to the international quality requirements.

Reference of Roszdravnadzor: today on the Russian market the great place and value are occupied by the medical products for invitro diagnostics and 25% of the market is accounted for the product produced in Russia. Russian Federation is one of the world leaders in this sphere. Possibilities of control department allow to promote domestic producers on the international market.

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