CFDA registration timescale

Hi

I have been asked by our marketing department how long the CFDA regsitration process takes but the CFDA website seems a little thin on detail if you can't read Chinese. To be honest I'm not even sure whether our active device is a Class 2 or 3 device by their classification system as I can't work out the bit about "Injury" and their is no guidance available (or even if this classification system is still current!). In the EU we are classed as IIb by Rule 9 if that helps!

Anyway, I have read the other CFDA threads on here and was surprised to find that the cost is now 30,000€, which was a bit of a surprise, but there is no information on timescales.

Any help greatly appreciated.

Cheers

 

Hi, Im not 100% sure about medical devices (I'm in IVDs), but its slow or very slow

There is a good webcast from Pacific Bridge Medical, which will give you a flavor of the requirements (http://www.pacificbridgemedical.com/webcast/china-medical-device-regulations-webcast/)

Below are some notes I made, remember it is likely that you will require a clinical trial.

Chris


Class II & Class III Devices with No Clinical Trial Requirement:
1. Chinese specification drafting (dossier preparation and specification drafting): Timeframe: about 1 month
2. Sample testing :Timeframe: about 6 months
3. Filing to the CFDA (CFDA preliminary review and acceptance notice): Timeframe: 1 month
4. CMDE review; CMDE will issue a supplementary notice: Timeframe: 60-90 working days.
5. Supplementary dossier preparation: Timeframe: maximum 1 year
6. Further CMDE review: Timeframe: 60 working days
7. CFDA final review and granting of the registration approval: Timeframe: 30 working days
Also note that clinical trials may be required for certain high-risk devices (e.g. implantable devices).

 

Thanks for the info VG, I shall have a look at that video you have linked to. Looking at the notes you made it says "Also note that clinical trials may be required for certain high-risk devices (e.g. implantable devices)." but I'm not sure our device is really in the same risk category as implantable devices, it certainly isn't in the EU or US.

Thansk for your input, very much appreciated

 

I'm not sure of the guidance on clinical trials for medical devices; for IVDs, it seems like all assays need a clinical trial; irrespective of class. It may be worth looking to see if any similar products are already on the Chinese market.

If you haven't already done so, you will need to find a local regulatory specialist in China. This can be someone working for a distributor, although that can cause problems long term.

Chris

 

Thanks again for your responses. I watched the video you linked to and it certainly seems like most devices would need to undertake clinical trials.

We haven't set anything up in China yet with regards to distributors or legal contacts but I don't think we are that far down the line yet. This reqest appears to have been a "What are we looking at for China?" type of request and from the video it appears that we would be looking at a big pile of do-do!