医疗器械FDAUDI食品FDA化妆品FDAVCRP注册化妆品CPNP 加拿大化妆品通报ISO13485体系建立medical device purchasing agent, China medical device sourcing, 

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    Sourcing medical device in China

    China has become the manufacturing center of the world for medical devices, However, searching for a qualified manufacturing facility for your medical product in China is not an easy task. Extensive screenings of potential suppliers and stringent due diligence is necessary to ensure that you find a capable, trustworthy supplier. It is essential to perform this step thoroughly as poor supply chain practices may have a serious negative impact on your business and reputation.

    We can help you locate and qualify supplier candidates, conduct due diligence, ensure compliance with local standards, and more. We can even act as your supply chain management consultant, or your souricing and quality control staff in China。

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    Our services to assist you in importing medical device from China include:

    ·         Initial supplier search
    Medical device manufacturer directories, trade shows, catalogs and internet sources are all sources for beginning a manufacturer search. However, it is critical to acknowledge that while there is a wealth of information on the internet, this should not be the sole foundation for qualifying capable suppliers.

    ·         Contacting, qualifying, and building relationships with capable medical device suppliers
    We will begin by initiating contact with suppliers via phone and email to pre-assess their capabilities, determine who actually owns the company, if the company possesses the manufacturing licenses for the devices they claim to produce, and how financially stable the manufacturer is.

    ·         On-site assessments & quality audits at supplier manufacturing facilities
    Face-to-face meetings are a crucial part of establishing and further developing business relations with candidate manufacturers. Although we will address inquiries similar or identical to the questions previously asked via phone and email, the impression received during the facility tour takes precedence over presumptions attained during the preliminary off-site investigation.We will confirm the following information during on-site visits:

    o    Supplier headquarters (business operations) and manufacturing facility addresses

    o    Direct contact information for all primary contacts (names, titles, direct phone numbers, email addresses, etc.)

    o    Year of establishment

    o    Main export markets

    o    Number of employees

    o    Number of total manufacturing facilities

    o    Annual revenue

    o    Compliance with local and international standards

    o    Relevant certifications (ISO 13485, CE certificates, etc.)

    o    Primary (main) product lines

    o    Secondary product lines (if applicable)

    o    Valid operating licenses (official business license, invoice sample, tax registration certificates, etc.)

    ·         Providing a detailed supplier report
    We will submit a detailed report summarizing each supplier’s capabilities and ability to make the required medical products. We will indicate our assessment of components such as factory equipment/machinery used, production area cleanliness and organization, the assembly process, risk management procedures, personnel, etc. and also indicate our overall rating for the supplier based on our assessment criteria.We will discuss the report with the client and answer any follow-up questions. We will also communicate with the suppliers to provide an evaluation of the total costs.

    ·         Providing supplier product samples for your review
    We will ensure supplier diligence and comprehension of your product specifications (color & design, weight, dimensions, raw materials used for components) as well as printing and packing specifications (package printing colors, box packaging and design, etc.) by requesting samples based on your individual requirements.

    ·         Conclude a sourcing agreement
    We will assist with negotiating a sourcing agreement. On your behalf, we will negotiate production costs for product samples, product molding costs, minimum order quantity (MOQ) per purchase order, product price per unit, packaging & labeling, printing fees, and payment terms.

    ·         Quality assurance inspections for product purchase orders
    Our QC inspector will perform and manage quality assurance inspections at the supplier’s manufacturing and/or freight forwarding facility before the products are shipped to your final destination.We will develop schedules and maintain reports for all Quality Assurance Checks.

    ·         On-going supplier management
    We will continue monitoring the manufacturing and sourcing process to ensure that the products are properly manufactured to your expectations.

    Whether you need comprehensive assistance with all services relative to the sourcing and manufacturing process, or would like us to consult on a specific sourcing and manufacturing function, we can develop and execute a plan that’s tailored to meet your requirements.

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    We, Shenzhen BBO Technology is your trustable partner of  medical device sourcing in China, because of

    1.    10 year experience in medical device industry  in China;

    2.    Our relationships with medical device suppliers in China;

    3.    Expertise in medical device regulatory and quality control;

    4.    We located in Shenzhen, the major medical device manufaturing area in China;

    5.    We charge service fee only, no hidden cost etc

    Our experienced specialists can help you find the most qualified medical device suppliers in China .

    Contact us: service@bbotek.cn

     

     

     



    标签:   medical device sourcing medical device purchasing
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