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Medical Device Made-in-China Policy: A Comprehensive Review and Implementation (II)

Responsibilities of the Marketing Authorization Holder (OEM)

Under the MAH system, OEMs can register “new” medical devices in two categories: the first type is innovative medical devices being produced for the first time from the R&D stage; the second type is medical devices that have been marketed in other regions and are now seeking entry into the Chinese market. Foreign enterprises aiming to register their products and obtain an MAH license must understand their responsibilities.

__Liable for Design and Development:

  • Ensure clinical trials are conducted.
  • Responsible for production and assembly.
  • Accountable for marketing and post-marketing surveillance.
  • Liable for product recalls and adverse event reporting.

__Contracting with a Contract Manufacturer:

  • Sign a Letter of Authorization and a Quality Agreement with a contract manufacturer.
  • Submit a Product Technical Requirement (PTR).

__Organizing Regular GMP Audits:

  • Conduct regular GMP audits to ensure compliance with quality standards.

__Data Authenticity in Clinical Trials or CERs:

  • Ensure the authenticity and accuracy of all clinical trial data or clinical evaluation reports.

Key Steps in the Registration Process

__Identify Product Type:

  • Determine whether the product is an innovative medical device or an already marketed device seeking entry into the Chinese market.

__Prepare Necessary Documentation:

  • Design and development documents, clinical trial reports, PTR, quality agreements, etc.

__Collaborate with a Contract Manufacturer:

  • Sign authorization and quality agreements.
  • Organize regular GMP audits to ensure compliance.

__Submit Registration Application:

  • Submit the registration application and all necessary documentation to the relevant Chinese regulatory authorities.

__Post-Marketing Surveillance and Management:

  • Establish and maintain an effective post-marketing surveillance system.
  • Timely report and address any adverse events.

Business Models for OEMs to Operate Successfully Under the MAH System

Under the MAH system, OEMs can achieve successful operations through different business models. Here are three possible models:

__Model 1: OEM Forms a Partnership with a Contract Manufacturer (CM)

  • Structure: OEM partners with a CM, both operating under a common holding company.
  • Advantages: Manufacturing processes are not duplicated, resulting in high resource utilization efficiency. The holding company can manage and optimize resources centrally, reducing costs and operational complexity.
  • Implementation Details: Both parties work closely in product design, production, and marketing, sharing resources and information to ensure product quality and compliance.

__Model 2: OEM Continues Partnership with an Existing Local CM

  • Structure: OEM continues its partnership with an existing local CM.
  • Advantages: Maintains established relationships, simplifying processes. The existing local CM is familiar with the OEM’s products and market demands, allowing for quick response and adjustment.
  • Implementation Details: The local CM has already been marketing the OEM’s device as “Made in China” through proper channels and authorization. Post-MAH, marketing and sales continue through the same channels and authorization.

__Model 3: Multinational OEMs Partner with China-Based CM

  • Structure: Specifically for US-based multinational OEMs, partnering with a China-based manufacturer to obtain the “Made in China” label.
  • Advantages: Quick market entry in China. Localized production can reduce tariffs and transportation costs, increasing market responsiveness. Especially for interventional medical devices and other Class III medical devices, US-based OEMs can immediately access Chinese hospitals and clinics if they partner with local manufacturers.
  • Implementation Details: Multinational OEMs need to select a suitable local manufacturer, sign detailed authorization and quality agreements, and ensure that the production process meets international standards and Chinese regulatory requirements.

Partnering with China Med Device

China Med Device, LLC (www.ChinaMedDevice.com) provides regulatory and commercialization turnkey solutions for medical device, IVD, CDx and combination products in China. As a qualified NMPA legal agent with offices in Boston, Beijing and Hainan, we can represent manufacturers for the complete product life cycle without their need to create a local entity in China. Our regulatory services include strategy, registration, type testing, product technical requirement (PTR), clinical evaluation report (CER), clinical trial, GMP and post-market surveillance. Our commercialization services include market research, reimbursement, partnership strategy and distribution qualification.

__Our Unique Advantages:

  • Full-Service Offering: We can help you obtain MAH status under any of the business models described earlier. If you are unsure which model to choose, we can provide a gap analysis.
  • Business Models 1 and 2: We assist you in finding MAH partners for business models 1 or 2, such as Quasar or others. We have the full capability to support product lifecycle compliance, ensuring product safety and effectiveness.
  • Business Model 3: We have the capability to handle Class III medical devices, supporting complex processes and technical requirements.
  • Turnkey Solutions: We provide comprehensive one-stop solutions for the entire production process, from the transfer-to-production stage to the production process itself, product delivery, and bidding and distribution in various provinces.

__Our Unique Capabilities:

  • Manufacturing Capacity in China: Our collaboration with Quasar offers significant advantages in manufacturing capacity in China, including cost, manpower, and timing benefits.
  • Integration of Engineering and Legal Compliance: We possess advanced engineering technology and legal compliance experience, meeting international production quality standards.
  • Strict Intellectual Property Control: We implement stringent control measures in the field of intellectual property to ensure your IP is fully protected.