Drugdu.com expert's response:

Chinese Current Regulations Have Lifted the "Only One Contract Manufacturer" Restriction

Medical device registrants/filers may entrust multiple qualified enterprises to manufacture products.

I. Regulatory Basis

II. Two Common Models

1. Multiple Entrustment for Finished Products (Multi‑source Supply)

Entrust the same finished product to multiple manufacturers to expand production capacity and ensure supply chain security.

Requirements:

All manufacturers shall produce in accordance with the same registered technical specifications, processes, and quality standards;

All entrusted manufacturers shall be indicated on the registration certificate.

2. Component / Process Subcontracting

Entrust different components (e.g., hardware, software, housing) or processes (injection molding, sterilization, final assembly) to different enterprises respectively.

The registrant is responsible for integration and final release.

III. Core Compliance Requirements

Entrusted Manufacturer Qualifications

Hold a Medical Device Manufacturing License matching the product category.

Pass quality system verification and have corresponding production capacity.

Primary Responsibility of the Registrant (Non‑transferable)

Bear full and ultimate legal responsibility for product quality, safety, and performance.

Establish a unified quality management system covering all entrusted manufacturers and conduct regular audits.

Unify technical documents, processes, inspection standards, and release rules.

Sign a delegation agreement + quality agreement with each entrusted manufacturer to clarify responsibilities, change control, adverse event handling, etc.

Prohibited Cases

High‑risk implantable medical devices (e.g., cardiac pacemakers, artificial joints) shall not be entrusted for production.

Entrustment to unqualified enterprises is prohibited;

Unauthorized changes to registered technical specifications are prohibited.

IV. Practical Key Points

The registration certificate shall indicate the name and production address of all entrusted manufacturers.

Adding or changing an entrusted manufacturer shall be reported to the provincial medical products administration where the registrant is located.

Establish a system for change control, deviation handling, and traceability across all entrusted manufacturers.