Up to recently, medical products certification was obligatory before their use in Russian medical centres. However, through evolution of the regulatory framework, the requirements to the terms used and to the procedures for issuing permits for the medical products use have undergone significant changes.
First, it should be emphasized that at present medical product certification can be considered a thing of the past. This term is no longer employed by professionals in official papers. Today, medical products certification is most often referred to in the framework of state registration and issuing of a medical product declaration. To complete the procedure of medical products certification, the manufacturer’s representative must prepare a set of documents that fully describe the product, its features and functions.
New requirements to original documents for medical products registration
At present, in order to use medical products legally it is required to complete the state registration procedure followed by issuing of a registration certificate. Medical products certificates are no more is use (except for the certificates that are still valid). The full list of required documents and the state registration procedure of medical products for various purposes are specified in Decree of the Government No. 1416 dated 27 December, 2012.
The Decree entered into force on 1 January, 2013 and imposed a series of requirements for the registration file that is submitted to Roszdravnadzor. Among key documents to be prepared by the medical product manufacturer and their authorized representative the following should be drawn attention to:
- specifications, technical and operation documents, as well as product image;
- results of tests and trials carried out: technical tests, toxicity tests and tests aimed at pattern evaluation of measuring instruments (if necessary);
- documents confirming the product safety and efficiency.
All documents must be drawn in accordance with the current standards. If the medical product is foreign-made and the supporting documents are drawn in a foreign language, then the applicant is required to submit duly certified Russian translations of all documents.
Our company provides the service of technical specification drawing.
To obtain such a document, you should provide the following information on the product:
Information required for drawing of technical specification
- Full name of the manufacturer
- Full name and position of the manufacturing company’s director
- OKPO code (All-Russian Classifier of Businesses and Organizations code) of the manufacturer, to be found at the official statistics agencies websites in the Russian regions at http://www.gks.ru/#dan.
- Product name for the technical specification cover page
- Purpose and area of use of the product
- List of models, makes, modifications, etc.
- OKPD12 code (OKP) (All-Russian Classifier of Products by Type of Economic Activity/ All-Russian Classifier of Products)
- Technical specification serial number within organisation
- Brief technical parameters (features)
- Brief list of accessories (materials and consumables)
- Types of package and packing material, list of documents provided in each package
- Conservation conditions
- Operation conditions
- Guarantee period