Sri Lanka Class IIb Medical Device Registration

Sorry folks, two new threads in one morning!

I have no experience of registering a device in Sri Lanka but Sales department has asked me what is required.

Could anyone enlighten me to the process please? For reference our device is Class IIb in europe.

Thanks

Hi..

The following documents are required to register a device in Sri Lanka.

1. A letter addressed to The Director Cosmetics, Devices & Drugs Authority, No.120, Norris Canal Road, Colombo 10. from the principals appointing A. Baur & Co.(Pvt) Ltd., as local agent in Sri Lanka. (This letter should be signed by the President, Chairman or Director of your company)
2. Product labels (original), outer cartons (original), broachers etc.,
3. Product information
4. Product Manual / Catalogues if relevant
5. Certificates such as EC, TUV .... as additional supporting documents (if available)
6. FDA Certificate OR Free sale certificate - original (A Certificate from the Health Authorities of the country in which it is produced, confirming that the device is in use there and the period of use and if not, reasons for not marketing it in the country of manufacture. )
7. List of countries in which the device is approved or registered for sale.
8. Registration samples
9. Stability studies ? if relevant and available
10. Available pack size/sizes & pack type of the relevant product intend to be registered, are required in a company letter head (letter should be addressed to The Director, Cosmetics Devices and Drug Authority, Colombo 10, Sri Lanka.)

Above all the data/documents should be provided in ENGLISH.

Regards,
Sreenu

Hi Sreenu,

I realise this post is quite old, but valid. Since we are registering in Sri Lanka and got the same list of required paperwork, with the exception of

Copy of product registration certificate-from any foreign country registration

Since we are CE marked and only sell in Europe, we don't have a foreign country product registration.

How shall I go about this?

Hi Mor628
Since you have CE marking, you can submit the EC/CE certificate + EC DoC.

Regards
Sreenu

Hi,

How if the class I device registration in Sri Lanka? Since it's only Class I, we don't have CE certificate, FDA certificate, what we can do?