IVD (in vitro diagnostic) Regulations in Srilanka

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Ajit Basrur

Staff member
Admin
#3
Hi..
Any idea of IVD regulations in SriLanka?
Thanks,
Sreenu
Sreenu,

I tried the SEARCH on Internet but could get only this - Guidelines for Procurement of Pharmaceuticals & Medical Devices but that does not have any mention of IVD.

Additionally, I could not get the website of the COSMETICS, DEVICES & DRUGS REGULATORY AUTHORITY OF SRI LANKA (CDDA) which is the regulatory body there but could get the address as 120, Norris Canal Road, Colombo -10, Sri Lanka.

OR

Ministry of Health, 385, Ven. Baddegama Wimalawansa Thero Mawatha, Colombo 10.
Tel. No: 011-2698507/2694033/2675449/2669192


Hope that helps !
 
Last edited:

Michael Malis

Quite Involved in Discussions
#5
Hi..
Any idea of IVD regulations in SriLanka?
Thanks,
Sreenu
Sreenu,

IVDs do not have any regulations in SriLanka (just medical devices)

Some countries in Asia/Africa such as Pakistan, Oman, Cambodia, Malaysia, Qatar, Syria, Yemen, Jordan, Kuwait, Libia, Iraq, Iran, Mongolia, Lebanon, etc. and some in CIS (Azerbaijan, Tajakistan, etc) still don't have any regulatory requirements!
 
Last edited:

sreenu927

Quite Involved in Discussions
#6
Dear Ajit and Michael

Thank you very much for your time & efforts in searching for me.

Ajit, I had the same document, which is unclear of the registration process.
However, I tried to get the CCDA contact number: +94-11-2687743/44.
I am going to call them now.

Michael, Thanks for the confirmation.
Malaysia has voluntary registration of Medical devices including IVD.

Regards,
Sreenu
 

Michael Malis

Quite Involved in Discussions
#7
Dear Sreenu,

Thanks for Malaysia information, I will update my records (has voluntary registration of MD and IVD).

Regards,
Mike
 

sreenu927

Quite Involved in Discussions
#8
Hi All..
I called SriLankan Drug Regulatory Authority and CDDA regarding the IVD regulations.
The gist of the conversation is as follows :
--confirmed that IVDs must be registered before selling in SL.
--But no concrete information about the required documents, duration, guidance etc..
--The website is under construction and it has to be through an agent.
-- the gudiance docs are under draft
--similar to medical device registration
--fees may vary from 7000 to 10,000 SL Rupees

--BETTER APPOINT AN AGENT AND PROCEED.

The contact number of CDDA, SL:
+94-11-2698896.

Regards,
Sreenu
 

Michael Malis

Quite Involved in Discussions
#9
I will call my local contact in the region - this info is different form what I have, however as you know "if we put every rule and guideline on a paper today, by tomorrow it will be obsolete!"
 

sreenu927

Quite Involved in Discussions
#10
Until I heard frm them, I too was in the same conception that no IVD regulations in SL. I was a bit surprised after the call..as no guidance docs, no proper information on registration requirements, bt still wanted us to register..
I would very much appreciate your local contact's feedback.

Thanks,
Sreenu
 
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