aRecently, you requested assistance with the FDA Registration and requirements in order to export to the US. My colleague Fiona Cai (from our China office) has sent you a email with the proper forms and information to proceed with your request. I am your US Regulatory Advisor and together ...
aRecently, you requested assistance with the FDA Registration and requirements in order to export to the US. My colleague Fiona Cai (from our China office) has sent you a email with the proper forms and information to proceed with your request. I am your US Regulatory Advisor and together ...
The FDA has regulatory authority over medical devices, such as pacemakers, contact lenses, and breast implants. In addition it regulates some radiation emitting consumer devices, including microwaves, x-ray machines, and cell phones. For products like these the FDA sets product safety standards that...
FDA Issues New Requirements under Final Rule for Registration of Food FacilitiesChristine Forgues Schlenker
Registration Requirements ASEANGCCLATAMCISAsiaPacific (exceptASEAN) Site registration YesYesYesYesYes PlantGMP approval Accepts FDA/EU/PICs approvalforFPsite. AuditbyGCC membercountriesof FPsite Majorcountriesdo audit.(Brazil, Mexico,Colombia) AuditbyCIS ...
FDA does not intend to enforce the registration requirement for owners or operators of facilities that first engaged in manufacturing or processing a cosmetic product after December 29, 2022 if they register within 60 days of first engaging in such activity or by July 1, 2024, whichever is l...
In this webinar, speakers provide an overview of the regulatory framework for the importation of pharmaceutical products in these two countries, including the requirements for obtaining marketing authorization.
These are changes that companies should begin to prepare for as soon as possible.Facility Registration and Product Listing RequirementsFacility Registration: An owner or operator of an existing facility that manufactures or processes cosmetic products for U.S. distribution must now register with FDA, ...
Francisco Partners, a prominent global investment firm specializing in technology, announced its acquisition of Jama Software for approximately $1.2 billion. Jama Software, known for its requirements management and traceability solutions, plays a crucial role in product development, particularly... Modern...
China CIQ inspection requirements for Imported food -RJS MedTech Inc.provide China FDA,SFDA,CFDA,MOH,MOA,AQSIQ,CNCA,CIQ registration approval license for cosmetics,health food supplement,medical device,IVD,drug,infant milk powder,dairy,pet food ,disinfec