EAC Certificate for Medical Technology and Drugs
The EAC Certification for Medical Devices and Medicines is a mandatory measure for the export of Medical Products to Russia and EEU Countries. Through EAC Conformity assessment of medical devices and medicines, the requirements for safety and quality are confirmed. EAC Conformity is attested by the certificate of SGR Registration and an EAC Declaration. Through the EAC Conformity confirmation, the requirements of the Technical Regulations of Russia and EEU States are taken into account.
State Registration of Medical Devices and Medicines
All tools, apparatus, devices, equipment, materials and similar products used singly or in combination with each other for medical purposes shall be considered medical products within the meaning of the Agreement on Common Principles and Regulations for the Treatment of Medical Products and Supplies within the Framework of the Eurasian Economic Union (EEU) dated 23.12.2014.
The medical devices are intended by the manufacturer for the prevention, diagnosis, treatment of diseases, medical rehabilitation and monitoring of the human body condition, medical research, modification of the anatomical structure or physiological functions of the body, prevention or termination of pregnancy. The functions of each product are not realized by pharmacological, immunological, genetic or metabolic effects on the human body, but may be supported by drugs.
Classification of Medical Products // Hazard Classes
Medical products are divided into 4 hazard classes depending on the potential risk, according to the decision of the Board of the EEU Commission N173 - On Approval of Regulations for Classification of Medical Products.
- Class 1 - Low Potential Hazard: Microscopes, Scales, Compression Garments, etc.
- Class 2a - Moderate Risk: Laboratory Technique, Lenses, Inhalation Apparatus, etc.
- Class 2b - High Risk: Condoms, X-Ray Machines, Defibrillators etc.
- Class 3 - Very High Risk: Implants, Cardiac Catheters, Lithotripters etc.
Process of State Registration of Medical Devices
State Registration of medical devices is a prerequisite for placing a medical device on the EAC Market of the Eurasian Economic Union. The State Registration is the responsibility of a special authority. In Russia, State Registration of medical devices and medicines is controlled by the Federal Agency for Health. After the successful process of State registration of medical devices, a certificate of registration is issued. The Certificate of State Registration is issued for an indefinite period of time and is valid in all EEU States.
State Registration of Medical Equipment
The process of State Registration can be divided into two phases (A and B).
Phase A // Preparation of Necessary Documents:
1) Preparation of Relevant Documents
- Technical Documentation
- Instruction Manual
2) Classification of the Medical Device
- Class 1 - Low Risk
- Class 2а - Moderate Risk
- Class 2b - High Risk
- Class 3 - Very High Risk
3) Investigations and Evidence
- Toxicological Investigation
- Biological Investigation
- Technical Investigation
- Electromagnetic Compatibility
- Metrological Certification
- Hygienic Certification
In addition, medical devices may be subject to EAC Declaration, EAC Certification, Metrological EAC Certification, or Hygienic EAC Certification.
4) Determination of the Reference State and the Member State involved
During the approval of medical devices, the applicant/authorized representative must select a reference state and a participating member state of the EEU. In the reference state, the registration will be carried out and in the participating member state, it will be verified that the application for registration and individual investigations have been carried out completely and correctly.
Phase B // Examination and Registration:
1) Application Submission
- Relevant Documents and Evidence
- Payment of Government Fees
- Review and Submission
Information in the application for registration:
- Product Description Listing Individual Components
- Information about the Manufacturer/Authorized Representative
- Place of Production
- Use of the Product
- Customs Tariff Number
- Classification according to Hazard Classes
Documents for Registration:
- List of Essential Requirements
- Technical Documentation
- Instruction Manual
- Documentation (product, application, accessories)
- Proof of Technical Investigations
- Proof of Toxicological Tests
- Proof of Pharmacological Investigations
- Proof of the Quality and Safety of the Product
2) Testing of the Medical Device
In the scope of medical device testing, the following contents are analyzed:
- Safety and Quality of the Product
- Design and Manufacturing Drawings
- Plans of Components, Assemblies, Circuits
- Listing of Applied Standards and Regulations
- Results of Technical Investigations
- Results of Toxicological Investigations
- Results of Pharmacological Investigations
- Results of the Clinical Investigations
- Results of the Material Tests
- Results of Stability Tests
- Evidence of Production Audit Performed
- Classification by Hazard Class
- Risk Analysis of the Product
- Validation of the Product
- Information about Labeling
- Information about Accidents
- Instruction for Use
Content and Documentation review can take up e up to 12 months. When all standards and regulations have been fully considered, an expert report is prepared.
3) Approval of the Product
The test report is issued by the competent testing body of the EEU Reference State and confirmed by the competent testing body of the EEU member State involved.
4) Registration of the Medical Device
After the product is approved by the competent inspection body, the registration of the product can be carried out. In this process, information about the medical device, marking, operation, illustration and risks are entered into the unified register of the EEU countries. The Certificate of Registration is issued by the certification body of the reference state.
EAC Marking of Medical Devices in Russia and EEU
Medical devices are marked with a special EAC MED marking in Russia and the EEU. An EAC MED marking indicates that the medical device meets the appropriate conformity requirements. Marketing products without the appropriate EAC MED Marking can be punished by heavy fines and confiscation of medical products. Rules and requirements for EAC MED Marking of medical products are established by the Decision of the Council of the Eurasian Economic Union N26, on EAC Marking of medical products on the EAC Market of the EEU.
Duration and Cost of Registering Medical Devices in Russia
State Registration of medical products is an elaborate, complex, costly and ongoing procedure. The duration and cost of State Registration of medical products depend on various factors, such as the product, complexity and risk class. The exact process of State Registration of Medical Products is always planned individually and based on the product. Application for State Registration for medical devices can take between 10 and 12 months.
Authorized Representation for EAC Certification
The Eurasian Economic Union regulations mandate that the manufacturer must have a registered office in the Common Economic Territory in order to apply for State Registration. The manufacturer must have a registered office in the Common Economic Territory in order to apply for State Registration. Thus, an authorized representative of the manufacturer is required to apply for and conduct certification processes in the Customs Union as long as the manufacturer does not have an establishment in the Eurasian Economic Union. For detailed information regarding the position of a legal contract person, contact us.
Legal Basis of Certification of Medical Devices
The legal basis for Certification of medical products and medicines in Russia and the Eurasian Economic Union are prescribed by the following legal norms:
1) Regulations for the Treatment of Medical Devices within the Framework of the EEU dated 23.12.2014.
2) Decision of the EEU N46 of 12.02.2016, Regulations for the Registration of Medical Devices.
3) Treaty on the Eurasian Economic Union of 29.05.2014.
4) Decision of the Board of the EEU N173 of 22.12.2015, Regulations for Risk Classification.
5) Decision N27 of 12.02.2016, General Requirements for the Safety and Efficiency of Medical Devices.
6) Decision of the Council of the EEU N26 of 12.02.2016, EAC MED Labeling of Medical Devices.
We offer the following services to our customers:
- Performance of EAC Declaration for Medical Devices
- Performance of EAC Certification for Medical Devices
- Consulting regarding EAC Declaration for Medical Devices
- Consulting regarding EAC Certification of Medical Devices
- Consulting regarding EAC Labeling of for Medical Devices
For more information regarding EAC Certification of Medical Devices and Medicines, please contact us.