Deeplight | introduction to all kinds of certification of sphygmomanometer exported to Japan and measurement certification of sphygmomanometer in Japan

Time:2022-09-28 Views:496
1. What certification do the sphygmomanometer need to do for export to Japan?
sphygmomanometer belongs to medical devices, Japanese medical device certification is a must. In addition to the certification of medical devices, the sphygmomanometer is an instrument for measuring human blood pressure, which belongs to the measuring instrument, and must be tested in accordance with the Japanese measurement method. In addition, we need to see whether the sphygmomanometer has other wireless functions, if there are other wireless functions may involve the Japanese telecom law date or the Japanese radio law telec certification, which are very common.

2. What is the Japanese Metrology Law? Japan‘s "metrology method" introduction
The Ministry of economy, Trade and Industry of Japan is in charge of national measurement work according to Japan's Metrology Law, which stipulates the legal management requirements for 18 types of specific measuring instruments. Including: taxi meter, scale (standard weight), thermometer, leather area meter, meter (water meter, hot water meter, gas meter, volume meter, etc.), field instrument (waste gas meter, waste water meter), density meter, pressure machine (including sphygmomanometer), flow meter, heat meter, maximum demand watt-hour meter, watt-hour meter, reactive power meter, illuminance meter, noise meter, vibration meter, concentration meter, specific gravity hydrometer. All the above products need to be tested in accordance with the requirements of the Metrology Law, and marked with certification marks according to the relevant requirements, indicating that they meet the requirements of the Metrology Law of Japan.

3. What are the types of blood pressure monitor? Do you all need to do metrological certification?
sphygmomanometer can be divided into the following types, as shown in the figure below. Except for mercury sphygmomanometer, other sphygmomanometer need to be certified by measurement method
1. Traditional mercury column (mercury column) type sphygmomanometer
2. barometer (spring) type sphygmomanometer
3. Electronic sphygmomanometer
4. The measurement certification period of the sphygmomanometer
The measurement certification of sphygmomanometer currently needs a prototype to Japan, and the cycle is about 6 weeks after the prototype to Japan

5. What do you need to prepare for the Japanese measurement certification of the sphygmomanometer? What information needs to be provided
The sphygmomanometer is a medical device product, which must give priority to preparing the certification of medical devices. In addition, the measurement certification also needs to prepare the following information
1. Japanese instructions
2. Circuit diagram
3. The BON table
4. Tags
5. A Japanese agent

The above content is about the introduction of the measurement certification of sphygmomanometer in Japan. Deeplight has completed the measurement certification in Japan for many domestic customers. Welcome to contact us for consultation.