Control over circulation of medical devices • Медрелис

Control over circulation of medical devices

2014
2015
2016
Quality non-conformities of medical devices according to reports of Roszdravnadzor
Registration certificates suspended or withdrawn
50
8
130
89
293
68
The number of inspections is increasing every year.
The circulation of medical devices prohibited from sale in the Russian Federation is subject to administrative and criminal penalties (Article 238.1 of the Criminal Code of Russia)
Statistics of state control over circulation of medical devices:
In accordance with the Federal Law No. 323-FZ dated November 21, 2011 "On the Fundamentals of Public Health Protection", it is prohibited to distribute fake medical devices, low quality medical devices, and counterfeit medical devices
The manufacturer's failure to timely provide information about changes in the characteristics of the medical device (design, materials, software version, labelling, etc.)
Obsolescence of Russian and foreign standards applicable to the medical device
Failure to update knowledge of laws governing the circulation of the medical device
1
2
3
It is often the case that distributors unknowingly become involved in distribution of products prohibited from circulation

The reasons for this are as follows:
We will prevent these problems to ensure free circulation of your medical device

Steps:

Search for information about changes in the medical device and checking for the relevance of applicable standards
Search for any changes with respect to the quality, safety and performance of your medical device in international and national sources and checking for the relevance of the standards applicable to it
Analysis of the information found
Not every change must be reported to Roszdravnadzor. We will assess all the risks to minimize your costs
List of mandatory amendments to registration
certificates / master files

A report with a list of amendments to be made to the master file / registration certificate

You can also order the following services:
Amendment of the master file and registration certificate to reflect the changes identified
Subscription for monthly monitoring of changes in your medical device
WORKING WITH US,
YOU WILL GET
GUARANTEES
We have been delivering on our promises for more than 10 years and we value our reputation
COMFORT
Roszdravnadzor will be timely notified about all changes in Medical device - you will avoid the risks of suspension or withdrawal of Your registration certificate
INTEGRITY
The price is fixed and not subject to change after the contract is signed
SPEED
Our quality management system allows for prompt delivery

We are trusted

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and more than 20 clients

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Contacts
+7 (495) 785-72-85
+7 (495) 785-72-84

info@medrelic.ru
Moscow, 109074
2/5/4 Slavyanskaya square, build. 3,
office 4057
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