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MDD & USA FDA Registration service

USA FDA REGISTRATION SERVICE

Medical Devices related

* Establishment registration and listings of device

* U.S. Agent & official correspondent

* Review and submission of 510(k) administrative 

* Review of device 

* Medical device master files (MAF)

* Device regulatory updates

Food and Beverages related

* Food facility registration,

* U.S. Agent 

* Prior notice 

*  Food canning Establishment and process filings

 * Label review

 * Food contact substances (FCS)

* Food and beverage regulatory updates

Drugs related

* FDA establishment registration

* U.S. Agent

 * Drug listings and label submissions

*  Authorizing official requirement

 * Label review

 * Drug Master Files (DMF)

Drug regulatory updates

Cosmetics related

* FDA cosmetic establishment registration

* FDA CPIS filings

* California safe cosmetics program (CSCP)

* Label review

* Cosmetics regulatory updates

Radiation-Emitting Device related

* Device reporting and accession number

* U.S. Agent

* Transition to U.S. FDA electronic reporting

* Device Review

* Device Regulatory Updates

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  • ATEX 2014/34/EU (EQUIPMENT OF EXPLOSIVE ATMOSPHERES)
    CE MARKING
    MACHINERY DIRECTIVE
    CE MARKING
    PRESSURE EQUIPMENT DIRECTIVE
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