We want to draw your attention to a very important bill. It intends to replace the current Order of the Ministry of Health of the Russian Federation № 7n “On Approval of the Procedure for Import of Medical Devices into the Russian Federation for the Purposes of State Registration”.
Comparison of the existing Order with the new draft law
We have compared the current Order No. 7n with the draft law and revealed the main differences:
|Order No. 7n||New draft law|
|1) Import authorization must be obtained for the software (which is a medical device).||┿||—|
|2) An import authorization must be obtained to amend medical device registrations when changes require testing.||—||┿|
|3) An application for import can be made in the form of an electronic document||┿||┿|
|4) An application for import in the form of a paper document can be submitted||┿||—|
|5) Import Permit||Paper||Electronic|
|6) One should obtain an import permit if the manufacturer is national and the production site (place of production) is foreign||—||┿|
|7) It is mandatory to indicate the full composition (scope of supply) in the import application.||—||┿|
|8) The import application must include the accessories||—||┿|
|9) The import permit specifies the manufacturer||—||┿|
|10) The import permit shall specify the production site (place of production)||—||┿|
|(11) There is a formal procedure for revoking the import permit) (e.g. in case of a technical error)||—||┿|
|(12) Refusal to issue an import permit shall be recorded in the Register||—||┿|
|13) Publicly available data on imported medical product||Applicant (name), name of medical devices, date of production, shelf life (service), number of imported samples||Applicant (name, INN, OGRN), name of medical devices, manufacturer (address, name), place of production (address), batch numbers, date of production, expiration date (as well as for service), number of imported samples, RU number (in case of changes)|
What remains unclear about the bill?
- Once the bill is passed, will it be possible to import a medical device for only one type of test (e.g. for toxicology tests only) by attaching only one contract?
Paragraph 8 p. 6 states that the application has to specify:
“6) information on organizations where the technical tests, toxicological studies, clinical tests, as well as tests for type approval of measuring instruments are planned (in respect of medical devices related to measuring instruments in the sphere of state regulation to ensure the uniformity of measurements), indicating the date and number of the contract for conducting the tests (studies)”.
That is, all kinds of tests at once.
At the importation stage, however, applicants often have not yet decided on the organization in which clinical trials will be conducted. And in cases where permission to conduct clinical trials is required, this document is actually the basis for concluding a contract with LPU. Is there a need to confirm the relationship between the national manufacturer and the foreign place of production? The draft law does not provide for such a document.