Introduction of amendments to the registration certificate and the registration dossier

Introduction of amendments to the RC

Following paragraph 38 of the Rules for the Registration of Medical Devices, approved by the Decree of the Government of the Russian Federation “On Approval of the Rules for State Registration of Medical Devices” (hereinafter Registration Rules) dated December 27, 2012 No. 1416, manufacturers or the authorized representatives of the manufacturers of medical devices (holders of registration certificates) should inform Roszdravnadzor of changes that do not require an examination of quality, effectiveness, and safety of medical devices (specified in paragraph 37 of the Registration Rules) within a period of up to 30 working days. These changes include:

a) change of information about the applicant, including the information:
– on the reconstruction of a legal entity;
– on a change in the name of the legal entity (full and abbreviated (if any), including company name), in the address of its location;
– on the change of the last name, first name and middle name (if any), the address of the place of residence of the individual entrepreneur and details of the documents confirming their identity;

b) change of information on the entity for which the registration certificate for a medical device is issued, including the information:
– on the reconstruction of a legal entity;
– on a change in the name of the legal entity (full and abbreviated (if available), including company name), in the address of its location or the last name, first name and middle name (if available), place of residence of the individual entrepreneur;

c) change in the address of the place of manufacture (production) of the medical device;

d) change in the name of the medical device if the properties and characteristics that affect the quality, effectiveness, and safety of the medical device have not changed, or the properties and characteristics have been improved while the functional purpose and (or) the principle of operation remain unchanged, including:
– an addition (exclusion) of accessories of the medical device or a change in their name;
– an introduction, change or removal of a trademark or other means of the medical device branding;
– a change in the number of units of a medical device or its components and constituent parts specified in the annex to the registration certificate;
– an addition or exclusion of the design variants (models) of the medical device;
– a change in the labeling and (or) packaging of a medical device;

e) change of the validity period of the documents included in the registration dossier by the manufacturer (producer) of the medical device;

f) change of information on the authorized representative of the manufacturer (producer) of the medical device.

Introduction of amendments to the registration certificate that does not require an examination of the quality, effectiveness, and safety of the medical device is liable to a state fee of 2,500 rubles.

Terms for the provision of services for amending the registration certificate:

In the vast majority of cases, 30 working days are enough to introduce amendments to the registration certificate that do not require an examination of the quality, effectiveness, and safety of the medical device.

Introduction of amendments to the registration dossier

Following paragraph 39 of the Rules for the Registration of Medical Devices, approved by the Decree of the Government of the Russian Federation No. 1416 “On Approval of the Rules for State Registration of Medical Devices” (hereinafter Registration Rules) dated December 27, 2012, amendments to the documents in the registration dossier of a medical device are made according to the results of the quality, effectiveness and safety examination of a medical device. The examination is conducted similarly to the quality, effectiveness and safety examination of a medical device for state registration, the manner of which is established by paragraph 21 of the Registration Rules. The registration dossier is amended if the registration body, after verifying completeness and reliability of the information contained in the submitted documents, has established that the introduction of the declared amendments entails a change in the properties and characteristics affecting the quality, effectiveness, and safety of the medical device, or improves its properties and characteristics while retaining the functional purpose and (or) the operating principle of the medical device.

The Federal Service for Supervision of Healthcare of the Russian Federation (Roszdravnadzor) charges a state fee for the quality, effectiveness and safety examination of a medical device when amending the documents of the registration dossier. The amount of state fee depends on the risk class of the medical device:

– class 1 – 32,000 rubles;
– class 2a – 48,000 rubles;
– class 2b – 64,000 rubles;
– class 3 – 104,000 rubles.

Terms for the provision of services for amending the registration dossier:

Replacement of the original copy of the RC

Following the requirements of paragraph 2, subparagraph b of the Decree of the Government of the Russian Federation No. 1416 “On the Approval of the Rules for State Registration of Medical Devices” (hereinafter referred to as the “Decisions”) dated December 27, 2012, registration certificates issued before the day this Decree came into force (that is, before January 1, 2013) were subject to replacement before January 1, 2021.

Such a replacement was carried out without going through the state registration procedure! Currently, the registration of products with non-replaced RC is cancelled. That is why in the state register of medical devices for them in the column “validity period of the RC” it is indicated: “does not work in accordance with subparagraph “b” of paragraph 2 of the Decree of the Government of the Russian Federation of December 27, 2012 No. 1416.”

At the moment, for such products, the previous registration is lost forever and it is necessary to go through the registration procedure again!

Receiving a duplicate copy of the RC

In case of loss of the original copy of the registration certificate or in case of its damage, the holder has the right to apply to the Federal Service for Supervision of Healthcare (Roszdravnadzor) with a request for a duplicate copy of the registration certificate, in accordance with paragraph 52 of the Rules for the Registration of Medical Devices established by the Decree of the Government of the Russian Federation No. 1416 “On approval of the Rules of state registration of medical devices” (hereinafter the Registration Rules) dated December 27, 2012.

In case of damage to the original copy of the registration certificate, a corrupted copy of the registration certificate is attached to the application for a duplicate copy.

Issue of a duplicate copy of the registration certificate is liable to the state fee of 2,500 rubles.

Following paragraph 53 of the Registration Rules, Roszdravnadzor issues a duplicate copy of the registration certificate within 7 working days from the date of receipt of the documents specified in paragraph 52 of the Registration Rules. The new copy of the registration certificate is marked with a “duplicate” note, and the original copy is marked with “the original copy of the registration certificate is declared invalid” note (if the original copy is available). After that Roszdravnadzor hands the duplicate copy of the registration certificate to the applicant (holder) or sends it by registered mail with a confirmation of delivery.