【EXPERT Q&A】Can medical devices be contracted for production?

June 4, 2025  Source: drugdu 70

Drugdu.com expert's response:

 

Medical devices can indeed be entrusted for production, but strict compliance with relevant regulatory requirements is essential. Below is a detailed analysis:

I. Regulatory Basis and Fundamental Requirements

According to the Regulations on the Supervision and Administration of Medical Devices and related supporting documents, medical device registrants and record-holders (hereinafter referred to as "registrants") may entrust qualified enterprises to manufacture medical devices. The core principle of entrusted production is that registrants bear primary responsibility for the quality and safety of the products, while the entrusted party must organize production in accordance with regulations, standards, and the entrustment agreement, and accept supervision from the registrant.

II. Key Restrictive Conditions

Prohibited Entrusted Production Catalog: High-risk implantable medical devices (such as cardiac pacemakers, artificial joints, etc.) are not allowed to be entrusted for production. The specific catalog is formulated and dynamically adjusted by the National Medical Products Administration (NMPA). Given the direct implantation into the human body and the high risks associated with such products, regulations require registrants to produce them in-house to ensure full process control.

Qualification Requirements for Entrusted Parties: The entrusted enterprise must hold a Medical Device Production License that matches the product category and has passed the quality management system inspection. Registrants should prioritize selecting enterprises with high levels of quality management and good credit records as entrusted parties and assess their quality assurance and risk management capabilities before entrustment.

III. Division of Quality Responsibilities

Primary Responsibilities of Registrants

1.Establish and maintain an effective quality management system covering the entire lifecycle of medical devices.

2.Regularly audit the operation of the entrusted party's quality management system to ensure compliance with regulatory requirements.

3.Assume responsibilities for product release, adverse event monitoring, product recalls, etc., and may not transfer statutory responsibilities through agreements.

Production Responsibilities of Entrusted Parties

1.Organize production in accordance with laws, regulations, production quality management norms, product technical requirements, and the entrustment agreement.

2.Be responsible for production activities and accept supervision and inspection from registrants and regulatory authorities.

IV. Management Requirements for Entrusted Production

Agreement Signing and Execution: Registrants and entrusted parties must sign a quality agreement and an entrustment agreement, clearly defining the rights and obligations of both parties, and translating the agreement requirements into executable management documents. The agreement content should cover production standards, quality control, responsibility division, and other clauses.

Cross-Regional Collaborative Supervision: For entrusted production involving cross-provincial operations, regulatory authorities in the registrant's location and the entrusted enterprise's location must share inspection results and jointly conduct unannounced inspections to avoid regulatory blind spots.

Information Recording and Reporting: Provincial drug regulatory authorities in the registrant's and entrusted enterprise's locations must record information related to entrusted production in the enterprise's credit archives and push it to the national drug regulatory data sharing platform.

V. Management Requirements for Special Products

For implantable medical devices, even if entrusted production is deemed necessary, registrants must dispatch personnel with relevant production and quality management experience to reside at the entrusted enterprise and provide on-site guidance and supervision for key aspects of production and quality management. The responsibilities of the dispatched personnel should be clearly defined in the quality agreement.

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