Pharma and medical devices

Belarus: Adopted standard on medical face masks

Decree of the State Standardisation Authority (Gosstandart) of April 10, 2020 No. 20 of the Republic of Belarus, adopted GOST R 58396-2019 “Medical masks. Requirements and test methods. " as the national Belorussian standard. 

Belarus: Clarification on certification requirements for face masks

Currently the mass production and sale of face masks in the Republic of Belarus is increasing constantly. The masks include those to be used as hygienic (sanitary-hygienic) products in order to prevent (the spread of infectious diseases that pose a danger to public health, including coronavirus COVID-19.

RUSSIA: Face masks. Types, standards and legal requirements

 

Certification of face masks in Russia

Face masks sold in the Russian Federation can be assigned to one of the following categories:

-Medical devices (medical products);

-Personal protective equipment; and

-Other face masks.

Medical face masks

Russia: Simplified registration procedure for low-risk medical devices

As of 19 March 2020, importers and manufacturers of low-risk medical devices will have to undergo a separate registration procedure for such devices.

The amendments to this effect were adopted by Decree No. 299 of 18 March 2020 that amended Decree No. 1416 of 27 December 2016.

Russia: Amended list of regulated narcotics, psychotropic substances and their precursors

As of 1 January 2019, the list of controlled narcotics, psychotropic substances and their precursors has been amended. The list of such substances and their precursors was adopted by Decree No. 681 of 30 June 1998. As a result of the amendments, several substances were added to List I and II.

List I (prohibited narcotic substances) was supplemented by the following positions:

Russia: Adopted Regulation on issuing clinical trial permits

As of 21 April 2018, developers of pharmaceuticals (the Applicants) are required to follow the adopted procedure if they wish to obtain a permit for a clinical trial for their pharmaceuticals.

The state agency responsible for issuing clinical trial permits is the Ministry of Healthcare of the Russian Federation.

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