CHINA AMENDS MEDICAL DEVICE APPLICATION SUBMISSION PROCESS

In an ongoing effort to refine and improve the systems and procedures for medical device registration in China, the National Medical Products Administration or NMPA (previously the CFDA) moved to a new on-line submission system and harmonized the applications table of contents to international standards.

On June 24, 2019 implementation of the new Electronic Declaration Information System (eRPS) system as prescribed in Order No. 46 (“Notice on the Implementation of Electronic Declaration of Medical Device Registration”). This move is a critical step to improve the efficiency of the applications review process.

At the same time, the NMPA released Order No. 26, “Technical Guidelines for Electronic Submission of Medical Device Registration Applications (Trial)” which informed manufacturers and Legal Agents of the new application format that very closely resembles the International Medical Device Regulators Forums’ (IMDRF) recommendations formally announced in the “Non-In Vitro Diagnostic Device Market Authorization Table of Contents (nlVD MA ToC)” released on March 21, 2019. 

New Table of Contents

China is now the second country, after Canada, to implement the IMDRF’s Table of Contents meant to harmonize the structure for premarket medical device submissions around the world. As of November 1, 2019, all applications are to be submitted electronically abiding by the following format and translated into Simplified Mandarin:

  1. Regional regulatory information
  2. Information on the device
  3. Information on non-clinical data
  4. Information on clinical data
  5. User instructions and labeling
  6. Information on the quality system
Using the eRPS System

While the new Table of Contents format is meant to assist international manufacturers gain access to the Chinese market easier, the implementation of the eRPS system is meant to provide a more efficient process for submitting documents and even working with the NMPAs reviewer, if needed. For example, the eRPS system has the ability to notify the manufacturer of which documents are required and/or still needed along with allowing direct dialogue between the manufacturer and the NMPA reviewer. It’s also important to note that the eRPS system will allow manufacturers to save some time and money not having to mail or physically deliver the large quantity of documents required by the NMPA. 

Manufacturers or their Agent can use the portal for:
  • Initial registrations or application for Medical Devices and IVDs

    ………………………

  • Changes to domestic class III medical devices and foreign class II and III Medical Devices, including instructions for use

    ………………………

  • Clinical investigation applications for foreign class III medical devices

    ………………………

  • Submitting innovative medical devices applications

    ………………………

  • Changing, Extending and Deregistering licenses for Medical Devices

    ………………………

  • Applications for “type testing” for manufacturers that are unsure of in-country testing requirements

    ………………………

Regulatory Background in China

Since the restructuring of medical device regulations in 2014 with Decree 650, China has had one of the most challenging medical device regulatory processes in the world. More recently the National Medical Products Administration (NMPA) has taken steps to decrease the regulatory burden on manufacturers seeking to enter the Chinese market.