【Case Study】Dynamic Electrocardiogram System Registration in China - Regulatory News - Medical Devices

1. Introduction

Product Name: dynamic electrocardiogram system, dynamic ECG, AECG, Holter
Product Composition: host, electro-cardio electrode
Working Principle: Dynamic ECG system obtains the cardiac activity potential of the patient through the electrocardiographic electrode placed on the body surface of the patient, and records the potential difference between the measurement points to obtain an electrocardiogram signal. DES analysis software plays back, analyzes, classifies and counts related electro-cardio data information
Mechanism: Before the mechanical contraction, the heart first produces electrical activation. The tiny current generated by myocardial excitation can be transmitted to the body surface through the body tissue, causing different potentials to be generated in different parts of the body surface. The visible record of the cardiac action potential is the electrocardiogram.
Typical Structure:

2. Classification

Classification Code: 07-03-01 Class II medical device, ECG measurement and analysis equipment
Product Description: It usually consists of a host computer, a power supply, an ECG cable, an ECG electrode, a recording and reading device, and a dynamic ECG analysis software. The mainframe portion usually includes a signal input portion, an amplification loop, a control circuit, and a recording portion. The electrical signals of different parts of the body surface are detected by electrodes, and the electrocardiogram waveform is formed by filtering, amplification, and analog-to-digital conversion, and continuous recording and analysis are performed.
Expected Usage: Used to measure, acquire, observe, and store dynamic electrocardiograms for clinical diagnosis.

3. Registration Unit

1) The full set of products can be placed in a registration unit;
2) The acquisition end and subsequent data processing software can be divided into two registration units;
3) The ECG electrode and the host can be divided into two registration units;
4) If the ECG electrode is fixed on the human skin by adhesive bonding, the adhesive tape is a disposable passive consumable and cannot be divided into one registration unit.
5) If the product has different models, if its working principle and performance structure are basically the same, consider placing it in a registration unit.

4. Technical requirements

The product must have the function of 24h continuous measurement. If it can analyze data, needs to use dynamic electrocardiogram database for analysis;
Other requirements: standard sensitivity, calibration voltage, sensitivity control etc.

Table 1 Relevant Product Standards

Standard Number	Standard Name
YY 0885-2013	Dynamic ECG system safety and basic performance specific requirements
GB 9706.1-2007	Medical electrical equipment – Part 1: General requirements for safety
GB/T 191—2008	Packaging storage and transportation mark
GB/T 14710-2009	Medical electrical environment requirements and test methods
GB/T 16886.1-2011	Biological evaluation of medical devices – Part 1: Evaluation and testing
GB/T 16886.5-2017	Biological evaluation of medical devices – Part 5: In vitro cytotoxicity test
GB/T 16886.10-2017	Biological evaluation of medical devices – Part 10: Stimulation and delayed hypersensitivity test
GB/T 16886.12-2005	Biological evaluation of medical devices – Part 12: Sample preparation and reference samples
GB/T 25000.51-2016	Software Engineering Software Product Quality Requirements and Evaluation (SQuaRE) Commercial Spot (COTS) Software Product Quality Requirements and Test Details
YY/T 0316-2016	Medical device risk management for medical devices
YY 0505-2012	Medical electrical equipment – Part 1-2: General standard for safety. Parallel standard: Electromagnetic compatibility requirements and testing
YY/T 0466.1-2009	Symbols for labeling, marking and providing information for medical devices - Part 1: General requirements
YY/T 0664-2008	Medical device software life cycle process
YY/T 0708-2009	Medical electrical equipment – Part 1-4: Safety common requirements. Parallel standard: Programmable medical electrical system
YY/T 1474-2016	Application of medical device usability engineering to medical devices

YY(/T): Industry standard (Recommendation)
GB(/T): National standard (Recommendation)

5. Clinical trials requirements

Animal Test or Small Sample Test: not required
Clinical Trials: not required
In ‘Medical Device Catalog Exempted from Clinical Trials’
Dynamic ECG system usually consists of mobile recorders and lead wires, and can also include data management software and accessories (lead wire, charger, USB cable, etc.), which can be used according to the number of leads, technical parameters, intended use, Additional auxiliary functions are divided into several models; for human body 24-hour dynamic ECG monitoring. Does not include automatic analysis diagnostics. Product performance indicators use the applicable parts of the following reference standards, such as: YY 0885-2013 Medical electrical equipment Part 2: Dynamic ECG system safety and basic performance specific requirements.
If dynamic ECG system has the function of automatic analysis diagnostics, the clinical trials are required.

6. Registration Cost and Duration

1) Product Testing

Test items	Testing duration(60working days total)	Testing fee(USD)
Safety Performance	60	6,000
EMC	60	3,700
Biocompatibility	35	2,500

Notes:
- This price is only the price of the dynamic ECG system, not including other integrated functions;
- The price of EMC is only the price of one operating mode. If there are multiple operating modes, it needs to be re-priced;
- Biocompatibility is only the price of a single material, such as a variety of materials and human contact, need to accumulate;
- Biocompatibility is only the way the material and the human body are in contact with the skin, short-term contact within 24h. If the electrodes are implanted or other, it needs to be re-priced.
2) Technology Approval
60 working days
Another 60 working days if the 1-year supplement is required
3) Administrative Approval
20 working days

If you would like to get the detailed registration proposal, please contact us via md@cirs-group.com.

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