Local Representation for Foreign Pharma & Medtech in China

A Local Agent in China is legal representative of overseas pharmaceutical and medical devices companies required as per the NMPA regulations. The Local Agent is responsible for the safety, efficacy, and quality control of the whole process of the production, operation, and use of its licensed drugs and devices in China. The overseas company is required to appoint a local agent before any regulatory interactive or filing activities in China.

Introduction

A Local Agent in China is legal representative of overseas pharmaceutical and medical devices companies required as per the NMPA regulations. The Local Agent is responsible for the safety, efficacy, and quality control of the whole process of the production, operation, and use of its licensed drugs and devices in China. The overseas company is required to appoint a local agent before any regulatory interactive or filing activities in China.

GRP can act as your local Agent in China, contact our team today to Inquire!

Local Agent should have:

1. Legal Person: A legal person of the Company located in China

2. Quality Management System: Have in place the appropriate Quality Management System that can support the agent work and can support its responsibilities.

3.3. Office Space: Have the appropriate office space, work environment, contact information, phone number to be able to perform the tasks that are required.

4. Product Traceability: Have a management system that ensures product traceability.

Responsibilities of Local Agent in China:

• Responsibilities of Local Agent in China
• Establishing and implementing a quality management system for drug traceability
• Establishing and implementing an annual report system for drugs and reporting them to the provincial or national health agency, where the agent is registered.
• Performing recalls of drugs, handling quality complaints, and reporting them to the provincial or national health agency where the agent is registered.
• Information to be reported: annual production and sales, post-marketing research and evaluation.
• Establishing a drug alert system, formulating a post-market drug risk management plan, and carrying out monitoring, identification, evaluation and control of adverse drug reactions and other harmful reactions related to the drug use as required.
• Submitting standards to the China health agency for audit and inspection by health agency.
• Being the liaison with the overseas holder

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