How registration process of medical device looks like?
Participants of registration process: Roszdravnadzor (Roszdravnadzor and expert centers staff), accredited testing laboratories, accredited hospitals.
Time: 7-9 months (fast track: 5-7 months, for 1 risk class devices only).
- same system as GMDN – classification rule #4n, used mainly by hospitals and doctors – identify medical device by type and intended use;
- risk class – 1, 2a, 2b and 3 (there are no 1s and 1 m – they are under 2a), mainly the same as in MDD;
- OKP classification – main Russian classificaton code for all devices (not only medical). GOST R certification system is based on OKP classification. This system is used by customs, Tax system and so on.
Description of stages:
1 stage – quotation (manufacturer send BWteam product information, on the base on this information we discuss price, prepare contract).
2 stage – application. BWteam prepares documents for dossier to start pre-clinical trials (safety, EMC and biocompatibility, special testing if required – for measuring devices for example).
3 stage – pre-clinical trials (safety, EMC and biocompatibility, special testing if required – for measuring devices, for example). All test, except of biocompatibility, usually called “technical testing”, biocompatibility – “toxicological testing”. All of them provided by accredited in Russian Federation labs on the territory of Russian Federation except of cases when medical device requires special condition of installation and maintance, in this case lab staff provides withness audit (factory inspection) and could use previously provided testing results. In the end of this stage registration file goes to RZN to be checked by government staff.
4 stage – Government people work (RZN and expert center) – expert in RZN and technical experts in expert organization checks registration file (dossier) and make a decision about clinical trials. If clinical trials could be started – permission for clinical trials is issued, if not – BW team receives request for amendment for registration file.
5 stage – Clinical trials are provided as document review in case of there is the equivalent device already registered in Russian market. For another cases – testing with patients and real intended use situation are required. Result of clinical testing – test report issued by hospital who has special accreditation from RZN to provide clinical trials.
6 stage – Government people work (RZN and expert center) – checking of clinical test report and make a decision about issuing of registration certificate. If all information in registration file is sufficient – registration certificate is registered in FS database (RZN database) and after that is issued as hard copy.
Fast track for 1 risk class medical devices – it is different from main scheme only for clinical trials (they are provided after pre-clinical). There is less of Government people work due to no need in permission of clinical trials (official paper) and registration process becomes faster.
Required documents (download list of documents here):
- Power of attorney (special draft),
- Business license for manufacturing company,
- ISO 13485 or ISO 9001 (could be also replaced by another documents),
- CE certificate (preferable but not a strict requirement),
- User manual,
- Technical dossier (technical specification, risk management file, clinical evaluation, validation sterilization report and another applicable characteristics for current product).
!!! All documents must be legalized in country of origin.
| How translation process and legalization are provided?
Find answer here
| Information about measuring medical devices
Measuring medical devices required special additional testing during registration process.
How to know that medical device is measuring medical device – find answer here.