Letter of the Federal Customs Service dated December 29, 2016 no. 01-11/67511 “On the distribution of the Roszdravnadzor explanatory letter”

The FCS of Russia hereby provides you with a copy of the Roszdravnadzor letter dated December 27, 2016, no. 01-63217/16, on the implementation from Jan 01, 2017 of the General Russian Classification Register of Goods According to the Type of Economic Activities (OKPD2) OK 034-2014 (KPES 2008), as approved by Roszdravnadzor order dated Jan 31, 2014, no. 14-st, and as applicable to the circulation of medical devices on the territory of the Russian Federation, which was received in relation to the related FCS query dated December 02, 2016, no. 01-30/61705.

Deputy Head of the Service
Lieutenant General of the Customs Service
T. N. Golendeeva

Attachment
Roszdravnadzor Letter
dated December 27, 2016 no. 01-63217/16

REGARDING THE PROVISION OF INFORMATION

The Federal Service for Surveillance in Healthcare has reviewed your query related to the implementation of the General Russian Classification List of Goods According to the Type of Economic Activities (OKPD2) OK 034-2014 (KPES 2008), as approved by Gosstandart order dated January 31, 2014, no. 14-st, and annulment of the General Russian Classification Register of Goods OK 005-93, as applicable specifically to the circulation of medical devices on the territory of the Russian Federation, and, within our related competences, we hereby inform you about the following:

According to Article 38 of Federal Act dated Nov 21, 2011 no. 323-FZ “On the basics of public healthcare in the Russian Federation” (hereinafter “The Act”), the circulation of medical devices, authorised for marketing as per the procedure set forth by the Government of the Russian Federation, or by a related local government agency, is allowed.

The only document to certify the fact of State Marketing Authorisation is the MA certificate issued for the medical device in question.

On the territory of the Russian Federation, the marketing authorisation procedure is regulated by Government of the Russian Federation order dated December 27, 2012, no. 1416 “On approval of the Rules for State Marketing Authorisation of Medical Devices” (hereinafter the “Rules”).

According to sub-clause “k” of item 9, and sub-clause “i” of item 56 of the Rules, the code of the medical device as per the General Russian Classification Register of Goods should be stated in the application for the State Marketing Authorisation of a Medical Device.

Due to the annulment of the General Russian Classification Register of Goods OK 005-93 and implementation of the new General Russian Classification Register of Goods According to the Type of Economic Activities (OKPD2), the Ministry of Healthcare of Russia, together with Roszdravnadzor, prepared related changes to the Rules, including but not limited to the rendition of sub-clause “k” of item 9, and sub-clause “i” of item 56 of the Rules in the version related to the “code of goods classification for medical devices”.

We also inform you that for medical devices already permitted for circulation on the territory of the Russian Federation in accordance with the existing procedures, no changes in the Marketing Authorisation Certificate are required by the Rules considering implementation of the new General Russian Classification Register of Goods According to the Type of Economic Activities (OKPD2).

The Ministry of Economic Development of Russia has developed forward and backward transition keys for the General Russian Classification Register of Goods According to the Type of Economic Activities OK 034-2014 and General Russian Classification Register of Goods OK 005-93.

For those keys please refer to the official web-site of the Ministry of Economic Development of the Russian Federation: economy.gov.ru/minec/activity/sections/classificators/index .

М.А.Murashko

Appendix N 1
Letter of the FCS of Russia
dated December 02, 2016, no. 01-30/61705

ON THE APPLICATION OF MARKETING AUTHORISATION CERTIFICATES WITH CONSIDERATION OF THE IMPLEMENTATION OF OKPD2

In accordance with the Order of Rosstandart dated January 31, 2014 no. 14-st (with amendments pursuant to order of Rosstandart dated November 10, 2015, no. 1745-st), on January 01, 2017, the General Russian Classification Register of Goods (OKP) OK 005-93 is annulled, and in its place the Russian Classification Register of Goods According to the Type of Economic Activities (OKPD2) OK 034-2014 (KPES 2008) is implemented.

According to a letter of the Ministry of Economic Development of Russia dated February 9, 2016, no. D28i-221, the Ministry of Economic Development of Russia had prepared transition keys necessary for the determination of correspondence between various general Russian classification registers. This letter therefore recommends the use of the aforementioned transition keys for the determination of the proper code per OKPD2.

Customs agencies, when taking a decision on the taxation of medical devices imported into the Russian Federation, are guided by the orders of the Government of the Russian Federation dated September 15, 2008, No. 688, and September 30, 2015, no. 1042, which inter alia contain OKP codes.

As for today, only the OKP code of a medical device should be included in the Marketing Authorisation Certificate issued by Roszdravnadzor.

We hereby ask you to promptly provide the FCS of Russia with explanations regarding the application of Marketing Authorisation Certificates issued by Roszdavnadzor as from January 01, 2017, intended for the import of goods on to the territory of the Russian Federation, with consideration of those certificates that did not contain OKPD2 codes.

N. Golendeeva

** the same in Russian – by link