Kiri

Dear Merili Saar-Abroi,

"By Aggregate report we mean any kind of report, for example Annual Safety Report, Periodic Line Listing Report etc. Thank you for your time. A prompt response would be highly appreciated." 

Thanks & Regards

Sai Kiran Topa

Safety Science Analyst

E: [email protected]

M: +91 7093615048 | fortrea.com

Dear Sai Kiran,

Thank You for Your enquiry.

The medical device regulations do not specify such term as ’aggregate report’. Please specify the questions nature as per medical device regulations terminology.

All the best,

Dear Sir/ Madam,

Hope this email finds you well.

Could you please provide us the contact information (preferably email) for regulatory authority and Pharmacovigilance for Estonia.

In addition, could you please provide the following information for  post-marketing Medical device Clinical Trials in Estonia.   

Post-marketing Medical Device Clinical Trials (AGGR requirements):

• Destination (Agency Name):

• Requirements:

• Aggregate Report Type:

• Timelines:

• Translation required for Aggregate Reports in regional language ? (Yes/No)

Thanks & Regards

Sai Kiran Topa

Safety Science Analyst

E: [email protected]

M: +91 7093615048 | fortrea.com

Fortrea
This e-mail may contain confidential, proprietary, or protected information - including protected health information - that is meant to be viewed only by the intended recipient or company. Any unauthorized review, use, copying, downloading or disclosure is strictly prohibited. If this e-mail is not intended for you, or if you have received this e-mail in error, please notify the sender immediately. Do not forward it to any further recipients and permanently delete this e-mail and all attachments. If you have questions or concerns, please see our privacy policy on Fortrea.com