For manufacturers of medical device and drug outside China, they must designate a legal person enterprise in China as a bridge for communication with NMPA, which is usually called the NMPA legal agent. The NMPA legal agent is not only responsible for the administrative work during the product registration and registration application, but also for the product quality and after-sales business together with the manufacturer after the product is put on the market.

      The NMPA legal agent can be your subsidiary in China, your partner, or a third party consulting service company like us. We will bring together our product regulatory experience and medical device registration expertise to work with you as your agent in China to help you succeed in the market.

Duties of a Local Legal Agent

  • We will be your contact with the regulatory authorities in China and responsible for the product registration process and subsequent regulatory compliance.
  • We will contact your local distributor and check the documents required for your application.
  • We will regularly check the compatibility of your products with the latest regulations, remind you to make changes and renewal applications in a timely manner, and assist you in managing product registration certificates.

          For specific NMPA legal agent duties and obligations, please contact us.

    Local Legal Agent Service

    Assistance in Product Management

     

     

    		 Certificate-related Issues
    • Change management
    • Instruction for use (IFU) management
    • Renewal application
    Product Information-related Issues
    • Adverse event management
    • Periodic risk evaluation report (PRER)
    • Product recall management
    • Unannounced inspection response
    Assistance in the Management of Distribution Network
    • Build bridges between your company and distribution partners (agents, logistics, and other service providers)
    • Assist in problem solving (e.g., support contract negotiations with Chinese companies)
    • Assist in visiting your Chinese distributor
    • Monitor competitive products in the market (Research on Competitive Products)
    • Product area authorization management for multi-channel sales
    • Assist distributor for bidding
    • Assist in filing the insurance code
    • Assist in unique device identification (UDI) filing
    Etc. Etc.

    Categories of Local Legal Agent

    • A wholly owned subsidiary of an overseas medical device company in China acts as a registration agent and legal agent for post-market supervision

    Advantages: It has medical device management qualification and strong management ability. Besides, it can cover the full life cycle obligations of registration, import, operation and post-market management.

    Disadvantages: In the past two years, due to the influence of the “two-vote system”, centralized procurement and other policies, the general distribution right of some products began to be sold by domestic large medical device operating companies, and enterprises do not directly participate in sales.

    • Distributors (Partners) in China

    Domestic medical device business enterprises with no equity relationship with registrants and filers operate agent products according to business needs, and act as the legal agent of registration agent, sales and post-market supervision.

    Advantages: It has medical device management qualification, basically able to meet the ability of medical device management after marketing.

    Disadvantages: The number of agent products is small, and its management ability is low. The overall level shows a huge difference. Distributors in China are centralized in charge of sales and post-marketing supervision in China, which bears risks.

    • Third Party Enterprises

    A enterprise that its registrant has no equity relationship with its filer, and is only engaged in the legal agent of registration agent and post-marketing supervision. It does not participate in the product operation.

    Our Advantages

    • Engaging an independent third-party consulting service as your local legal agent can save you time and money.
    • Engaging an independent third-party consulting service as your local legal agent can make you retain full flexibility in choosing or replacing channel partners as required, as well as retain full control of certificates.
    • We can help you manage your distributors in China.
    • We can assist distributors in answering professional questions of NMPA.
    • We will keep abreast of the latest regulatory information, and communicate with you in a timely manner when necessary to propose countermeasures.

    Contact Us

          Please contact us if you or your business is experiencing the following problems:

    • Wouldn’t it be better and more convenient for local distributors to focus on sales and marketing while doing certificate management?
    • If I want to change distributors, can I discard all labels, product pages and packaging?
    • How should I submit analysis results and reports to local regulatory authorities after adverse events occur?
    • How to effectively manage local distributors in various regions?
    • If my product needs to participate in bidding, how should I apply for regional authorization?
    • How should I apply for a medi-care code?
    • Do I need to apply for UDI for my product?
    • If I already have a Gs-one code, do I need to re-register and apply for a new UDI code in China? If not, how can I make a local filing?
    • I don’t know how to define the minimum sales unit of a product.
    • How should I declare corresponding process if the product of our company is recalled? 
    • What should I do after my product is sampled by NMPA?
    • What do I need to do after the upgrading of GB9706 standard?
    • If I plan to change my current legal agent, what should I do to prepare for it?