The state customer rejected the application for an invalid certificate for medical products — the Federal Antimonopoly Service agreed with this
The customer rejected the application due to an invalid registration certificate. It followed from the register of medical devices that a new certificate was issued for the medical device, but the participant presented the old one.
The participant, in particular, explained:
the change of the certificate is not attributed to the grounds for the cancellation of state registration of medical products;
the goods were purchased before the certificate was changed. It is valid for medical products with an expired expiration date, which were produced before the renewal and within 180 calendar days after it;
if a new certificate had been attached to the application, the customer would have refused acceptance, since the documents for the goods would not correspond to the documents from the application.
The controllers supported the customer:
according to the Rules of state registration of medical products, when the registration certificate is changed, the old one becomes invalid. The document from the application has become invalid;
under the terms of the purchase, the delivery time was 290 days. A registration certificate for a product that was produced within 180 calendar days after the date of renewal would cease to be valid during the execution of the contract. The customer correctly rejected the application.
The Sverdlovsk UFAS also supported the customer in a similar situation. The controllers noted: the change of the registration certificate does not interfere with the circulation of medical products. However, the decision on whether the participant meets the requirements of the notification and Law No. 44-FZ is made by the customers taking into account the documents from the application.
Document: Decision of the Chuvash Federal Antimonopoly Service of Russia dated 09.12.2022 in case N 021/06/49-1078/2022