How to get Radio Frequency Conclusion (RFC)?
In this case study we would like to provide you with information about certification of medical equipment which also has RF interface and it must be mandatory approved and licensed by issuance of Radio Frequency Conclusion (RFC).
We received a big and complex order from a Swiss manufacturer who is a producer of such equipment. The scope of the order included the whole set of approvals required for the devices in Russia, i.e. EAC DoC TR CU 020, FAC DoC, RFC. However, in this case we will draw your attention to RFC process. Let’s go into details.
Product in question: Titrators operating on two frequency ranges – 125kHz and 13.56MHz.
According to the requirements, the frequency range of 125 kHz should not be licensing in Russia, however, 13.56MHz is the range which should be licensed in Russia meaning that RFC should be issued.Main requirements that should be taken into consideration for RFC:
- Testing is a mandatory requirement. We will need one sample of each declared model. The sample setup should be radiated and with all required accessories for the testing
- In order to ship samples for testing, the first step that should be taken is getting Temporary Import Permission. This is a document which is prepared within 7-10 working days and allows you to send samples for testing.
Required documents:
- Technical description
During the process we have faced with several obstacles one of which was testing.
We have received 3 samples of Titrators, one per each of the declared models. Two of the samples were verified and they worked properly. However, the third sample was not switched on. Our technical stuff tried to make all necessary actions to understand the reason why it does not work in a proper way. After a series of actions, nothing changed and we have to apply to our customer informing him about the problem. We assumed that the sample has been damaged while being shipped to Russia.
In order to make a right decision and confirm our assumption, we made a series of videos showing the problem to our customer.
It was figured out that we were right and the sample seemed to be damaged during transportation process.
The main thing is attention
Taking it into account, please, be attentive when choosing a logistic company that will be responsible for your delivery.Testing is the main and the longest part of the process for RFC. We wasted about 1 month trying to solve the issue of such a failure with a damaged sample and had to postpone the tests.
The solution was found out and we sent a damaged sample back to the customer receiving a new one that should work properly.
In spite of facing with a lot of obstacles during the process, it has been completed successfully.
We are very happy that our customer can finally sell the devices in Russia and the certification process has finished.
If you have any questions about Radio Frequency Conclusion (RFC) and need consultancy, please, feel free to contact us and we will be pleased to assist you and take on your case. You may always lean on our assistance via [email protected].
Read more about Radio Frequency Conclusion (RFC) here: Communication means (RADIO & TELECOM)
By Kristina Shestakova
Head of Business Development