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  • MEDICAL EQUIPMENT

    ONE STOP FOR ALL YOUR REGULATROY NEEDS

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SHANGHAI SPICA MANAGEMENT CONSULTING CO.,LTD.

Shanghai spica management consulting was established in 2018 and its headquarter is located in Lingang New Area, Shanghai, on the banks of Dishui Lake on the coast of the East China Sea.


Shanghai spica management consulting will provide medical device companies, pharmaceutical companies, food companies, electronic equipment companies and some individuals in mainland China with product compliance, good production/operation practices, market access and other regulatory consulting services, training services and agents service.

20+
Years of Experience
1200+
Happy Customers
94%
Satisfaction

What is Special with Us and Why Our Clients Like Us?

Our strong technical team spread in three continents along with their commitments to core values has helped I3CGLOBAL build long-term, value-centric relationships with customers and become one of the best and dependable global US FDA & EU Regulatory Consulting Firm.

  • The USA Bioterrorism Act directs FDA to take steps to protect the public from any threats via the food supply.

    To carry out, the FDA enforces all manufacturers and importers to register their facilities involved in the supply chain.


    It also imposes us with the requirement to be given advance notice on shipments of imported food also known as prior notice.

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    FOOD/FOOD SUPPLEMENTS

  • The Voluntary Cosmetic Registration Program, so-called VCRP regulation is made by the FDA for cosmetic manufacturers and brand owners.

    VCRP insists that all ingredients used for cosmetic products must be intimated to the FDA via a so-called system called ingredient statement filing.

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    COSMETICS

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    US FDA controls the sale of drugs.

    All establishments have to register and list the drug products before the sale or import of such products to the United States of America.


    The registration is to be followed by Finished drug manufacturers, brand owners, API manufacturers, and drug testing laboratories.

    DRUGS

  • CE Marking according to new Medical Device Regulation (MDR 2017/745) and In-Vitro Diagnostic Regulation (IVDR 2017/746).


    US FDA 510k clearance for medium risk and high-risk devices followed by device registration and listing.

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    MEDICAL DEVICES