Myasnitskaya st, b.40/1
Moscow

Registration Certification for Medical products at the first submission!

Documents check, development of technical specifications, all required testing to timely achieve registration certificate.

Order

8 years

of practice of medical
devices registration

20 experts

and managers to provide registration

70 RC

issued since 2010

3 Candidates of Medicine

on the payroll

Why is registration
of medical products required?

Registration of medical products includes performance of state expertise to confirm quality, safety and effectiveness of the products. Only after registration and certification medical product can be allowed for sale.

List of medical
products subject to registration

In accordance with the RF law No.61-FZ on Circulation of medical products dated 12.04.2010 the following medical products are considered subject to state registration:

all medical products (original, reproduces, biosimilars) to be put into circulation overt the RF for the first time;

new combinations pf the earlier registered medical products;

earlier registered medical products manufactured in other types of medical form or other dosage

IMPORTANT!

In compliance with the governmental Decree No.1314 dated December 3, 2015 ON COMPLIANCE OF PRODUCERS OF MEDICAL PRODUCTS TO THE REQUIREMENTS OF GOOD MANUFACTURING PRACTICE (GMP) all medical products producers should have GMP certification issued by the Ministry of Industry and Trade of the Russian Federation. According to the above Decree Attek Group is authorized to perform full-scope certification support on the territory of the Russian Federation and outside.

 

Legal Norms

Registration of medical products
is performed in accordance with the following legal norms:

Ministry of Industry and Trade of Russia Order No.916 dated June 14, 2013 (edition dated December 18, 2015) On approval of requirements of Good Manufacturing Practice (registered in the RF Ministry of Justice No.29938 dated September 10, 2013)

Ministry of Industry and Trade of Russia Order No.1714 On approval of Administrative regulation of the Ministry of industry and trade of the Russian Federation for state service on certification issue and compliance of medical products producers to the requirements of Good Manufacturing Practice (registered in the RF Ministry of Justice No.43175 dated August 9, 2016)

Ministry of Industry and Trade of Russia Order No.261 dated February 4, 2016 On approval of application forms for issue of certificate on compliance of medical products producers (foreign producers) to the requirements of Good Manufacturing Practice and inspection evaluation for compliance of medical products producers (foreign producers) to the requirements of Good Manufacturing Practice (registered in the RF Ministry of Justice No.41341 dated March 9, 2016)

Ministry of Industry and Trade of Russia Order No.9 dated January 11, 2016 On approval of cost evaluation method for inspection evaluation performed in order to check compliance of medical products producers (foreign producers) to the requirements of Good Manufacturing Practice for issuing certificate of compliance of medical products producers (foreign producers) to the requirements of Good Manufacturing Practice Practice (registered in the RF Ministry of Justice No.40925 dated February 2, 2016)

Ministry of Industry and Trade of Russia Order No.1997 dated December 12, 2013 On approval of Recommendations for medical products production and quality control processes arrangement

Federal Law No.61-FZ on Circulation of medical products dated 12.04.2010 (enforced on 01.09.2010).

Ministry of Health and Social Development of the RF Order No.1413н dated November 23, 2011 reg. Approval of the methodological recommendations on preparation of the documents to make an application file for registration certification of medical products.

Order No.750н dated August 26, 2010 reg. Approval of rules for performance of testing of medical products an preparation of expert summary.

Download all documentation

Main questions

What were the changes in 2017?

Registration application file for medical products shall be submitted in form of Common Technical Document (CTD). Besides, in accordance with amends to the law FZ-61 within framework of the registration procedure for medical products Russian GMP certificate shall be included in the registration application file, namely: copy of certificate of compliance of the production to the valid requirements issued by the Ministry of Industry and Trade of the RF.

How many pharmaceutical forms shall be included into the registration application file?

Separate registration application form shall be prepared for every pharmaceutical form. One application form can include single pharmaceutical form with various dosages, concentration and volume.

What is the validity period of the registration certificate for medical products?

In accordance with Article 28 of the Federal law of the Russian Federation No.61-FZ dated April 12, 2010 reg. Circulation of medical products registration certificate for medical products with stated pharmaceutical forms and dosages has no expiry date except of the certificate issued for 5 years term for medical products at their first registration in the Russian Federation.

After 5-years term the certificate shall be replaced with the one without expiry date provided the state registration is confirmed.


How to order this service?

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You have questions?

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8 800 333-25-40
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