CLASS III - Preparing a registration dossier for a dermal filler

[Fatima444-4]

Dear All ,

Good morning.

Iam in the process of preparing registration dossier for a dermal filler. In Europe, it is classified as class III.
I plan to submit the product to MENA region. I did not receive the master dossier yet from the supplier.
In order for me to review the master dossier correctly, what are the key / essential points / documents which must be available withe regards to the following:

1. Status of Devices distribution
2. Essential principles checklist
3. Post-market requirements/ vigilance system and risk assessment
4. Process Validation Studies
5. Safety and effectiveness data, risk assessment, pre-clinical and clinical studies
6. Shelf life study

Actually this is my ever first project for medical device.

Your kind input, guidance , feedback is highly appreciated

Thanking in advance

 

[Fatima444-4]

appreciate your input

 

[Ronen E]

Not sure I understand what exactly you're looking for.

I'm not aware of a single, uniform regulatory scheme fro MENA region (I assume you mean Middle East North Africa region). What are your target countries? Most likely you'll have to assess your situation for each one separately.

Once the requirements are clarified, the contents of any existing dossier can be assessed against them.

Cheers,
Ronen.

 

[Fatima444-4]

Thank you Ronen for your response

I mean in general ( not country specific) , what are the points i should take care of in the following sections:

1. Status of Devices distribution
2. Essential principles checklist
3. Post-market requirements/ vigilance system and risk assessment
4. Process Validation Studies
5. Safety and effectiveness data, risk assessment, pre-clinical and clinical studies
6. Shelf life study

i believe most of countries have similar requirements for class III MD

 

[Ronen E]

i believe most of countries have similar requirements for class III MD

No, they don't. Regulatory requirements can vary a lot between countries, especially when you go to places like Africa.

I also don't understand what you mean by that checklist. Where did it come from? Usually when such a list is provided, there's guidance that comes along with it and explains what is (at least roughly) expected under each item.

 

[Fatima444-4]

Dear Ronen, many thanks for your patience

i will start the process with france.

 

[Ronen E]

France is part of the EU.
The requirements that currently apply are according to 93/42/EEC - the Medical Devices Directive (the MDD).
For design dossier contents requirements please refer to Annex VII s. 3 and to Annex II s. 4.

Please also refer to this Elsmar thread for clarification and guidance.

In that thread I linked to a guidance document, here's the direct link for your convenience.

 

[J0anne]

Why are these Class III? The last time I marketed dermal fillers globally they were Class II in every country.

 

[J0anne]

I've found it. I think it's attached