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MR Sattu Sreenu Babu

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Singapore

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1 to 5 of 39 total

RE: Question Regarding New Vietnam Regulations

Posted By Sattu Sreenu Babu 25-Jul-2017 05:37
Found In Egroup: Regulatory Open Forum \ view thread
If you have a legal entity then it is fine. If not, you need to have a 3rd party to hold your product license. Your local Vietnamese distributor can also hold your product license. Estimated processing time is 4-6 months. Regards Sreenu

RE: ISO 13485 :2016

Posted By Sattu Sreenu Babu 25-Jul-2017 01:35
Found In Egroup: Regulatory Open Forum \ view thread
There is a context of Technical File in the NB MED 2.5.1/Rec 5. Regards Sreenu

China -Trading license

Posted By Sattu Sreenu Babu 14-Jul-2017 09:31
Found In Egroup: Regulatory Open Forum \ view thread
Hello - In China, if a company has a trading license (operating license) to operate high risk medical devices, is it required to have extended if it wishes to sell low risk medical devices? Is a trading licence issued according to risk classification of medical device or just medical devices? Is it ...

RE: Documentation for foreign markets

Posted By Sattu Sreenu Babu 18-Jun-2017 22:28
Found In Egroup: Regulatory Open Forum \ view thread
For Middle East countries, please check with your counterpart, whether it MOH Stamp or "Company Stamp"; Even if they clarify you that it as MoH stamp, explain through a signed declaration letter and company stamp on it. Good luck! Regards Sreenu ------------------------------ SATTU Sreenu ...

RE: CE marked products

Posted By Sattu Sreenu Babu 08-Jun-2017 20:11
Found In Egroup: Regulatory Open Forum \ view thread
Hi Harsha, For Malaysia: If CE mark, then the Conformity Assessment Body (CAB) assessment is just "verification" rather than full assessment. For Singapore: if one regulatory agency (from GHTF members), then it will be abridged submission pathway. For Thailand: CE mark does not matter for registration. ...