Decree of the Government of Russia dated July 4, 2020 N 982 establishes that from January 1, 2021, such legal acts as:
• Rules for the destruction of seized falsified, substandard and counterfeit medical products;
• Regulation on licensing the production and maintenance of medical equipment;
• Procedure for monitoring the safety of medical devices;
• Requirements for supply of KIMGZ medicines and medical devices for the provision of primary health care and first aid;
• Procedure for reporting by subjects of circulation of medical devices about all cases of detection of side effects that are not specified in the instructions for use or the manual for the operation of the medical device;
• Requirements for the complete set of drugs and medical devices for emergency medical aid packages and kits.
Also, the specified legal act introduces changes to the list of products, the conformity of which is confirmed in the form of a declaration of conformity. This list excludes such a section as “medical, sanitary and hygienic and non-shaped patient care items”, “medical products”, “medical products made of cotton yarn”, “medical containers made of glass”.
With regard to the revoked legal acts, new documents have been posted on the federal portal of draft regulatory legal acts.
For example, an assessment of the regulatory impact of the draft decree of the Ministry of Health of Russia “On approval of the procedure for monitoring the safety of medical devices” is currently being carried out. The new draft procedure establishes a list of information that is the basis for monitoring the safety of medical devices and also establishes measures that can be taken by Federal Service for Surveillance in Healthcare based on the results of monitoring the safety of medical devices.
Also, the Ministry of Health of Russia has developed a draft procedure for reporting by subjects of circulation of medical devices about all cases of detecting side effects that are not specified in the instructions for use or the operation manual of a medical device, about adverse reactions during its use, about the peculiarities of the interaction of medical devices with each other, about facts and circumstances that pose a threat to the life and health of citizens and medical workers during the use and operation of medical devices. The project stipulates that medical organizations operating in the field of circulation of medical devices must inform the manufacturer of medical devices about events that have signs of an adverse event, as well as provide them with access to medical devices that may be associated with adverse events. Based on the results of corrective actions for the safety of a medical device, a manufacturer of medical devices is obliged to issue a notice on the safety of a medical device.
In addition, a public discussion is currently underway on the draft resolution of the Government of the Russian Federation “On Approval of the Regulation on Licensing Activities for Production and Maintenance (except for the case if maintenance is carried out to meet the own needs of a legal entity or individual entrepreneur) of medical equipment” establishes an exhaustive list of types of work (services) carried out within the framework of licensing activities for the production and maintenance of medical equipment and also determines that the performance of work, the provision of services in terms of technical maintenance of medical equipment may be carried out by the licensee at the address of operation of medical equipment not specified in licenses as the address (addresses) of the place of implementation of the licensed type of activity, which does not require re-issuing the license.
It is noteworthy that according to the new draft resolution of the Government of the Russian Federation “On Approval of the Procedure for the Destruction of Seized Falsified Medical Devices, Substandard Medical Devices, and Counterfeit Medical Devices”, substandard medical products and counterfeit products, on the basis of the decision of Federal Service for Surveillance in Healthcare on their withdrawal from circulation and destruction by its consent or by a court decision, transfer the specified medical products to an organization that destroys medical products, on the basis of an appropriate agreement. However, the mechanism for making such a decision, as well as its form, is not defined in the draft act developed by the Ministry of Health of Russia. Attention is also drawn to the need to define a detailed procedure for the transfer of such medical devices.
Public discussions are also being held on the draft requirements for the packaging of medical products and medical devices for emergency medical aid packages and kits. The project introduces provisions that provide for the possibility of completing the packing for the provision of emergency medical care with one of the drugs within one pharmacological group. Due to the actual cessation of production, the specified project excluded drugs: digoxin, chloramphenicol, zinc bisvinyl imidazole diacetate. Medical devices are excluded: a sterile hydrogel anti-burn dressing (based on allyloxyethanol and lidocaine), a central vein puncture needle from a pediatric resuscitation kit for emergency medical care in connection with duplication (included in a central vein catheterization kit contained in a specialized (resuscitation)). The list is supplemented with such drugs as a recombinant protein containing the amino acid sequence of staphylokinase, terlipressin, sodium chloride + potassium chloride + calcium chloride dihydrate + magnesium chloride hexahydrate + sodium acetate trihydrate + malic acid, propafenone, ceftriaxone (instead of the drug chloramphenicol), ketoprofenicol. The list includes medical devices: non-sterile elastic fixing bandage (7.5 cm x 2 m), non-sterile elastic fixing bandage (10 cm x 2 m).
September 6, 2020
Associate of BRACE Law Firm ©