ELMAS Medical
The Gateway to Russian and CIS market for MedTech and Pharma Companies

According to the market research firm GlobalData, the Russian pharmaceutical sector was valued at USD 20.91 billion in 2016, expanding at a compound annual growth rate of 13 per cent to reach USD 38.56 billion by 2021.

While offering an excellent opportunity for medical device manufacturers, Russia has its own regulatory system that must be considered for any device entering the marketplace, though it is already being sold in other regions. Russia’s pharmaceutical sector is conspicuous for its continued reliance on imports and the relative underdevelopment of domestic production. And, like many markets, Russia requires an in-country representation of any manufacturer aspiring to bring medical products into the country. This could include, a company-owned manufacturing or sale site within the country’s borders, a distributor operating within the country, or an in-country paper-holding agency. Besides, they are expected to assure that local suppliers and/or distributors address the requirements needed to coordinate with any follow-up inspections, should the need arise. At this juncture, MedTech companies must work with a local, experienced regulatory partner to navigate through the complex maze of medical device regulations.

Elmas Medical, a leading certification and registration body in Russia, stays ahead of regulatory changes and helps medical device manufacturers and pharma industries from all over the world steer through the registration processes within the Russian federation. With over ten years of experience in medical device registration and regulatory consulting services for Russia and CIS countries, Elmas offers services that are designed to assist clients in obtaining necessary authorizations and approvals across all stages of the registration process. As the legislation requires local testing inside the country, Elmas owns an accredited functional diagnostics laboratory for medical devices testing in Russia and currently, it has more than 150 ongoing projects.

Addressing his firm’s modus operandi, Andrey Fadeev, sales Director at Elmas Medical and IE Business School MBA alumni says, “We utilize advanced CRM and ERP systems to track all the regulatory processes, create the required reports and documentation, and answer queries from federal inspection officers.”

Elmas assigns a fluent English-speaking manager to every client, thereby assisting them through the technical trial, compatibility testing, clinical trial, and many other stages involved in the registration process. Elmas’ team of experienced regulatory experts keep themselves updated with the ever-changing national regulatory requirements and procedures for medical and pharmaceutical products registration in Russia and CIS countries.

“Sometimes they might ask five questions, sometimes fifty,” points out Fadeev. “Elmas Medical’s expert manager will be quick and well prepared with the statistical reports during a federal inspection if the need arises.”



The company utilizes special procedures to ensure a high probability of success and guarantee that the product complies with all the federal rules and regulations, from the initial phase itself. Elmas’ experienced team includes accredited certification bodies authorized to validate products and management systems. Its partnership with international certification bodies enables Elmas to carry out certification processes and assess conformity to international standards. The company is also an accredited authority for certification of medical device manufacturers for compliance with the Russian version of GOST ISO 13 485 within the System of Voluntary Certification of Management Systems.

To further elaborate Elmas Medical’s prowess within this region, Fadeev explains working with a client for medical device registration. During the initial engagement, the client requested for a reliable distributor before beginning with the registration process. And as per their request, Elmas provided the client with market access reports pertaining to the circulation of medical devices in the Russian Federation and a report of all the distributors that import the similar type of medical products. Elmas negotiated with the local distributors on the client’s behalf to serve as their future distributors. The stronghold and experience in Russian MedTech market allowed Elmas to assist the client in localizing several of their products in Russia in the following years.

“We work hard to satisfy the manufacturer and the federal services as well,” says Fadeev. Elmas Medical has been active on the Russian market of regulatory consulting, medical products registration services since 2014, and the company’s portfolio features over 120 medical products successfully registered in Russia and CIS countries. Elmas’ high success rate in bringing global MedTech companies into the Russian market is a clear indication of its efficiency and a testament to its competencies across this region.