Process steps for NMPA registration

In China, the registration of medical devices is an important step in ensuring product safety, effectiveness, and compliance with national standards. This process is supervised and executed by the National Medical Products Administration (NMPA). The process of NMPA registration is relatively complex, covering multiple stages and detailed steps to ensure the quality and compliance of the applied products. The following is an overview of the general steps in the NMPA registration process:





1、 Preparation stage




1. Collect data and prepare documents

Before applying for NMPA registration, the applicant needs to collect and prepare a series of documents and materials related to the product. These documents include but are not limited to:

Basic information of the enterprise: including the company's business license, production permit, etc.

Product technical documents: detailed descriptions of product technical specifications, design drawings, manufacturing processes, material composition, etc.

Quality management system documents: documents that prove that the production process of the enterprise complies with the requirements of the quality management system, such as the ISO 13485 quality management system certification certificate.

Clinical trial data (if applicable): High risk or new technology medical devices require clinical trial data related to product safety and efficacy.

** * Product manual and label * *: Ensure that the content of the product manual and label is accurate, clear, and in compliance with Chinese regulatory requirements.




2. Confirmation of Applicant Qualifications

The applicant must be a legal person or other organization established within the territory of China and have legal business qualifications. Foreign applicants need to designate a legal representative or authorized agency within China to handle the application on their behalf.




2、 Application submission




1. Select the registration category

Based on the characteristics and risk level of the product, the applicant needs to determine the registration category of the medical device, namely Class I, II, or III, as well as special categories (such as in vitro diagnostic reagents, implantable medical devices, etc.). The registration requirements for different categories of products vary.




2. Submit registration application

Submit the prepared registration application documents and related materials in accordance with the format and requirements specified by NMPA. This usually includes two methods: electronic submission and paper submission.




3、 Review and Evaluation




1. Technical review

NMPA will conduct a detailed technical review of the submitted technical documents, including a review of the product's technical specifications, design, performance, and other aspects. The review process may involve experts from multiple departments and professional fields.




2. Clinical evaluation (if applicable)

For medical devices that require clinical evaluation, NMPA will organize or recognize third-party organizations to evaluate clinical trial data. This step aims to verify the safety, effectiveness, and clinical applicability of the product in actual use. During the evaluation process, experts will carefully analyze the design, execution process, result data, and statistical significance of clinical trials to ensure that the clinical performance of the product meets the requirements of Chinese regulations and standards.




4、 On site inspection (if necessary)




After completing the technical review and clinical evaluation (if applicable), NMPA may conduct on-site inspections of the production site as needed. The main purpose of on-site inspection is to verify whether the production conditions, quality management system operation, and product production process of the enterprise comply with the contents stated in the registration application documents. The inspector will focus on inspecting production equipment, raw material control, production records, quality control measures, and other aspects to ensure that the enterprise can continuously and stably produce products that meet quality standards.




5、 Approval and certification




After comprehensive review and evaluation, if the product meets all registration requirements, NMPA will officially approve the registration application for the medical device and issue a medical device registration certificate. The registration certificate is an important document for the legal sale and use of products in the Chinese market, as well as an important symbol of the quality and compliance of enterprise products. At the same time, NMPA will publish registration information on its official website for public access and supervision.




6、 Post regulation




After obtaining the registration certificate, the enterprise still needs to accept the later supervision of NMPA. This includes regular product quality inspections, adverse event monitoring reports, and continuous supervision of the quality management system. Enterprises need to submit relevant reports and data in a timely manner in accordance with NMPA requirements to ensure that products maintain high quality and compliance throughout their entire lifecycle. At the same time, enterprises also need to pay attention to the latest regulations and standards released by NMPA, adjust and improve their quality management system and product design in a timely manner to adapt to market changes and policy requirements.