Global Regulatory Pulse

Chinese State Drug Administration Releases ‘Notice on the Implementation of Electronic Declaration of Medical Device Registration’

In Asian Market, Consulting, Regulatory by Lei Yang

In order to implement relevant requirements in the “Opinions on Deepening the Reform of the Examination and Approval System and Encouraging the Innovation of Drug Medical Devices,” the Chinese State Drug Administration issued the “Notice on the Implementation of Electronic Declaration of Medical Device Registration” (No. 46 of 2019) on May 31, 2019. Simultaneously, the government authority also published “Technical Guidelines for Electronic Submission of Medical Device Registration Applications (Trial),” both of which took effect on June 24, 2019.

Around the same time, the medical device registration Electronic Declaration Information System (eRPS) went live and is now operational in accordance with the directory list (ToC) of the International Medical Device Regulatory Agency Forum (IMDRF) Registration Declaration Specification (RPS) project.

Electronic declaration is applicative for various medical device registration activities, including:

  • Registration
  • Registration changes
  • Extension registration of a third category domestic medical device
  • Second and third category import of medical devices
  • Clinical trial approval of a third category medical device (high-risk)
  • Licensing change reviews of medical devices
  • Review of innovative medical devices

When comparing the RPS-ToC catalogue and current requirements of registration application materials (Announcement No. 43 and No. 44), it is observed that although the two sets of documents have varying directory settings and levels, the general technical requirements are essentially the same.

The eRPS system sets the current registration application requirements in the form of RPS-ToC. The directory level and related format requirements are set according to the international general specifications related to IMDRF, but the basic requirements for application materials are also fundamentally the same as current requirements.

Medical device manufacturers, by utilizing the eRPS system, can achieve greater efficiency when registering products, including cost reduction and improved security of application materials.

eRPS and Changes to NMPA Registration Requirements
The above changes, as they relate to the medical device registration process, were highlighted during eRPS training provided by the National Medical Products Administration (NMPA). Additional information is provided below.

Document Preparation
Previously, device registration files were required to follow Order 43 (2014); currently, registrations must follow technical guidelines for electronic submissions found in Order 29 (2019).

Document Submissions to NMPA
Prior to eRPS implementation, registrants were required to submit hard copies of their dossiers to NMPA administrative acceptance service centers via mail or in person. Dossiers underwent “simple review” by acceptance service center officers upon receipt.

Following the launch of eRPS, NMPA no longer requires hard copies of dossiers in favor of electronic copies. Medical device registrants may still submit hard copies of dossiers under existing submission processes and formats until November 1, 2019, when use of eRPS becomes mandatory. In such cases, applicants must also include electronic copies via USB storage devices. Furthermore, dossiers must now undergo “strict review” at the Center for Medical Device Evaluation (CMDE).

Technical Evaluations
Previously, supplementary notices were sent to NMPA acceptance service center directors for further examination after initial simple reviews. Under eRPS, all department reviewers will discuss supplementary opinions before sending supplementary notices to directors.

Supplementary Documentation
Previous requirements entailed preparation and submission of supplementary documents in hard copy format to CMDE (in-person or through the mail), and CMDE reviewers had the option to request additional supplementary data. Now, supplementary documents must be submitted electronically through the eRPS system.

RPA Conversion Directory (EU/U.S.)
Provided below is a comparison chart of Chinese supporting documents by EU and U.S. requirements.

China EU US
No. Table of Contents Supporting Document Supporting Document
1 Application Form
Product Name Instructions for Use
NMPA Catalogue of classification
PM confirmed product name
Instructions for Use
NMPA Catalogue of classification
PM confirmed product name
Classification NMPA Catalogue of classification NMPA Catalogue of classification
Code list Product Description
PM confirmed code list
Product Description
PM confirmed code list
Structure and composition Product Description
Instructions for Use
Product Description
Instructions for Use
Intended use Intended Use
PM & MA confirmed intended use
Intended Use
PM & MA confirmed intended use
Applicant name and place Legal Manufacturer and General Information Legal Manufacturer and General Information
Manufacturing site Legal Manufacturer and General Information Legal Manufacturer and General Information
2 Certificate Documents
2.1 The authorization/qualification documents of the enterprise ISO 13485 Certificate ISO 13485 Certificate
2.2 Supporting documents of marketing authorization and quantification certificate EC Certificate
Declaration of Conformity
510(K)
CFG
2.3 Copy of Business License Business License Business License
2.4 Power of Attorney General template of each BU General template of each BU
2.5 Agent Guarantee letter General template of each BU General template of each BU
2.6 Other Statements General template of each BU General template of each BU
3 List of basic requirements for safety and effectiveness of medical device List of Applied Standards and Essential Requirements List of Applied Standards and Essential Requirements
4 Summary Information Product Description Product Description
5 Research Information
5.1 Product performance study Product Verification and Validation Product Verification and Validation
5.2 Biocompatibility evaluation study Biocompatibility Biocompatibility
5.3 Biological safety study N/A N/A
5.4 Sterilization / disinfection process study Sterilization Sterilization
5.5 Study on shelf life and packaging Transport and Packaging Shelf life and Packaging
5.6 Animal study Special Materials Animal research
5.7 Software study Product Verification and Validation Product Verification and Validation
5.8 Other studies Product Verification and Validation Product Verification and Validation
6 Manufacturing information
6.1 Information description of the manufacturing process of non-active/active products Manufacturing process and Quality Control Manufacturing Flow
6.2 Manufacturing site Manufacturing process and Quality Control Manufacturing Flow
7 Clinical evaluation material CER
MA confirmed china CER/CT report
CER
MA confirmed china CER/CT report
8 Risk analysis material of products Risk Management Risk Management
9 Product technical requirement
9.1 Product technical requirement (CN two pieces and EN one Piece) Sourcing confirmed PTR Sourcing confirmed PTR
9.2 Consistency Guarantee of Product Technical Requirement General template of each BU General template of each BU
10 Product Type-testing report
10.1 Type-testing report Sourcing confirmed PTR Sourcing confirmed PTR
10.2 Pre-assessment advice on Product technical requirement Sourcing confirmed PTR Sourcing confirmed PTR
10.3 Declaration of Testing Sample Code and Test Report General template of each BU
Type-testing report
General template of each BU
Type-testing report
11 Samples of instruction for use and label
11.1 Instruction for use Instructions for Use
MA,PM,QA confirmed IFU
Instructions for Use
MA,PM,QA confirmed IFU
11.2 Label samples of minimum sales unit Labeling Labeling
12 Conformity statement
12.1 Conformity statement General template of each BU General template of each BU
12.2 Self-assurance statement General template of each BU General template of each BU

How Can NAMSA Help? Navigating China’s regulatory landscape can be overwhelming for any medical device manufacturer – not to mention very cost-intensive. That’s why having the right partner, at the right time, can be invaluable in achieving reimbursement requirements, market success and accelerated timelines.

NAMSA is the industry leader in driving successful regulatory outcomes through effective interactions with the CFDA, and also the most experienced in industry at accelerating regulatory submissions and approvals for device manufacturers. This expertise has been proven to save medical device organizations up to $17M in costs and 23 months in development timelines (read our most recent case study here).

If you are interested in speaking with us about your Chinese development efforts or other global regulatory strategies, please contact us at www.namsa.com/contact-us. You may also visit our regulatory consulting webpage here.

Authors:

Lei Yang serves as Principal Regulatory Consultant for NAMSA China.