Welcome to my monthly review of updates on the medical device regulations landscape in Russia and the Eurasian Union for November 2018:
- First Registration Files for Eurasian Medical Device Registration Procedures and other Eurasian Medical Device Regulations Updates
“The first applications for registration under the Eurasian Economic Union (EAU) medical device system have been filed for review by competent authorities of Kazakhstan and Russia.” It was announced by the Deputy Director of the Technical Regulation and Accreditation Department of the Eurasian Economic Commission (EEC) in Moscow at a conference organized on 15 November 2018 in Moscow by the medical device manufacturers association IMEDA together with the European Association MedTech Europe and EEC. During the same event it was announced that the unified information system for registration of medical devices will be launched “in full mode” by the end of this year. Unreadiness of this system was, until now, considered as one of the main barriers to starting registration procedures for the harmonized market.
In addition, on 16 November 2018, the EEC published approved versions of several third-level documents:
- Regulation # 25 – On criteria for classifying products as medical devices in the EAU (link in Russian);
- Regulation #176 – On the single register of organizations conducting testing/trials of medical devices for registration in the EAU (link in Russian);
- Regulation #177 – On the single database on safety monitoring of medical devices in the EAU ( link in Russian);
Earlier in November, the EEC published English translations of all second-level Eurasian medical device documents. The link is available on the official EEC website.
- Clarification on Valued Added Tax (VAT) for Medical Devices
On 2 November 2018, The Russian Ministry of Finance published a clarification letter (link in Russian) on exemption from VAT for the importation and sale of medical devices in the Russian Federation.
According to the letter, medical devices imported and sold in Russia are exempt from VAT if two conditions are met: the first is the presence of a registration certificate for the medical device, and the second is the inclusion of the product in the list of devices, approved by government resolution No. 1042 of 30 September 2015.
- Update of some Medical Device National Standards in Russia
It is important and often critical to use the most updated version of the national standards for the preparation of the technical documentation, testing, and assessment of medical devices in Russia. Several GOST standards relevant for registration of medical devices in Russia will be updated within the next two months.
Thus, on 1 January 2019 the new versions of the following national standards will come into force:
- Sterilization of health care products. Moist heat (Part 3). Guidance on the designation of a medical device to a product family and processing category for steam sterilization (link in Russian);
- Packaging for terminally sterilized medical devices. Guidance on the application of ISO 11607-1 and ISO 11607-2 (link in Russian);
- Medical devices utilizing animal tissues and their derivatives (link in Russian);
On 1 February 2019 the following national standards will also come into force:
- Medical electrical equipment. Part 2-49. Particular requirements for the basic safety and essential performance of multi-functional patient monitoring equipment (link in Russian)
Thank you for following my blog, which is a non-commercial project with the objective of making Russian and Eurasian medical device regulations clearer for regulatory professionals. You can also follow my updates on Twitter @Meddevrus.