【Case Study】Electronystagmography Instrument Registration in China

1. Introduction

Product Name: Electronystagmograph (ENG), Nystagmus inspection system, Optokinetic nystagmus instrument, videonystagmograph (VNG)

Product Composition:

VNG: Consists of system hardware (VNG video control box, VNG eyepiece, adapter, remote control) and system software.

ENG: Usually includes three parts: electrode, amplifier and recorder. It is detected by the electrical signal of the electrode's eye, amplified by an amplifier, and traced with a recorder.

Working Principle:

VNG: The eye movement mode of the patient is recorded by an eye mask with infrared photography function, and the parameters are analyzed by a computer software system to provide a reference for nystagmus examination.

ENG: The eyeball is a bipolar sphere with a positive charge on the cornea and a negative charge on the retina. The sclera acts as an insulator, causing a potential difference between the cornea and the retina. The electrical axis is consistent with the visual axis. When the eyeball is in the positive position, the difference of the potential is about 1 mA, which forms an electric field on the head and face. When the eye moves, the electric field will undergo a corresponding spatial phase change: an electrode is placed on each side of the eyeball, and a small potential change can be recorded by the amplifier and recording facility, or by computer acquisition analysis, it is ENG after statistical processing.

Typical Structure:

VNG: Composed of system hardware (VNG video control box, VNG eyepiece, adapter, remote control) and system software

ENG: Composed of three parts: an electrode, an amplifier and a recorder. Detected by the electrical signal of the electrode's eye, amplified by an amplifier, and traced down with a recorder

2. Classification

Classification Code: 07-09-02 Class II Ocular electroencephalogram equipment

Product Description: It usually consists of three parts: an electrode, an amplifier and a recorder. Detected by the electrical signal of the electrode's eye, amplified by an amplifier, and traced down with a recorder

Expected Usage: For examination of vertigo

3. Registration Unit

1) Products with different principles should be registered separately

2) The product recorder of the ENG principle should be registered separately.

3) Software and hardware cannot be registered separately

4) A product can include the detection function of VNG\ENG principle at the same time

4. Clinical Trials

Animal Test or Small Sample Test: not required

Clinical Trials: required

5. Registration Cost and Duration

1) Product Testing

Notes:

1. EMC price is only the price of one operating mode, if there are multiple operating modes, it needs to be re-priced;

2. Biocompatibility is only the price of a single material, such as a variety of materials and human contact, need to be accumulated;

3. Due to the small number of products on the market and no standards, the error about safety performance testing fee may be large

2) Technology Approval

60 working days

Another 60 working days if the 1-year supplement is required

3) Administrative Approval

20 working days