SFDA (Saudi Food and Drug Authority) and MDMA Registration System

[iceviper]

Hi guys,
I wanted to know if someone here has some experience with SFDA registration. I'm currently on the marketing authorization phase and my application is being rejected over and over again. They keep asking me to correct the brand name or provide the "format of the identifier number".

So, does anyone can provide any insight? Share some experience?
I don't understand what they want.

Many thanks!

[sreenu927]

Hi
I have been doing registration of products with SFDA; however, indirectly!
Our counterpart will directly liaise with SFDA.

May be due to terminology differences, I am not sure what you meant by "Marketing Authorisation Phase"?

However, reg the process, we provide MANY authorisation and declaration letters wherein we give Product category, name and models, if any!
In the below link you will find the recent Medical Device Registration Process in China by EMERGO for your better understanding!
http://elsmar.com/Forums/showthread.php?t=47154

Also, I may check with my counterpart in China, if you let the exact SFDA's response!

Regards,
Sreenu

[iceviper]

Dear sreenu,
Thank you but I had to mention that I mean the Saudi FDA.

[sreenu927]

In that case, I hv changed the title from China to Saudi.

Provide the actual response from SFDA. Let me see, if I can help u.

Regards,
Sreenu

[iceviper]

First of all, they want me to provide the Format of medical device identifier number. I'm not sure what they mean here. Can you assist?

[sreenu927]

From SFDA regulations, the process is as follows, form my knowledge:

To obtain a market authorization for a medical device:
- submit application to SFDA
- SFDA will appoint a Conformity Assessment Body (CAB) to each application
- CAB reviews and evaluates the application as per Medical Devices Interim Regulation (MDIR)
- CAB then confirms that the submitted docs are sufficient and apply to the medical device
- SFDA will issue a marketing authorization in writing to the manufacturer permitting the medical device to be placed on the KSA (Kingdom of Saudi Arabia) market.

From the information you provided, I understood that SFDA has requested you the format of your instrument serial number. Say for example, if the medical device serial number or LOT number is 234560512.
So your identifier number is a 9 digit number whereby first digit denotes the site location (1-location A, 2-location B), 2nd digit denotes the type of instrument/model number, next 3 digits are running numbers starting from 001 to 100 and the last 4 digits indicate month and year of manufacture.

Hope this may help you!

Regards,
Sreenu