JAPAN MIC (TELEC)Outline
The technical regulations conformity certification required to export a wireless communication device to Japan means that the specific radio device meets the technical standards of the Japanese radio law, where the specific radio equipment is defined in the specific radio standard compliance regulations.Applied Equipment
All communication terminal devices, wireless devices, capacitors, etc. are designated as target items.Related Agency
Ministry of Internal Affairs and Communications ([Link])
PSE (Product Safety Electrical appliance & Material)Outline
The PSE Mark System, Japan's electrical goods safety certification, is a certification system under the DENAN Law, a new form of the Dentori Mark (T-Mark) Act, which used to be applied to electrical and electronic products in Japan. It is a government-controlled certification, such as Korea's electricity product safety certification (KC MARK), and is prohibited from customs clearance and sales in Japan before certification is obtained. PSE is divided into two categories: specific electrical appliances and other electrical appliances.Applied Equipment
Specific electrical appliances: 116 items, such as wires, fuses, wiring equipment, heating appliances, electrical therapy equipment, etc.
Other electrical appliances: 341 items, such as electric heating appliances, power application machinery equipment, light source and light source appliances, electronic application machinery equipment, etc.Related Agency
Ministry of Economy Trade and Industry ([Link])
PMDA (Pharmaceuticals and Medical Devices Agency)Outline
In Japan, medical devices can only be sold if they are approved or certified by PMDA (Comprehensive Organization for Medical Devices) or a third-party certification body designated by the Ministry of Health, Labor and Welfare. Medical devices are classified as Class I to Class IV according to the degree of risk and should be approved or certified through the appropriate screening process if included in the medical device items specified by PMDA. In Japan, only business operators who have obtained permission to manufacture and sell medical devices can obtain medical device approval and certification through revenue sources in Japan after recognition by foreign manufacturers.Applied Equipment
Class 1: Anti-radiation apron, mercury capillary thermometer, mechanical stethoscope, piezoelectric cap for brain waves, glasses lens, rotating lung capacity meter, etc.
Class 2: X-ray diagnostic devices, digital panoramic x-ray diagnostic devices, low-frequency stimulators, blood, medical heating devices, etc.
Class 3: Angiography kit for medication administration, probes for intra-vascular ultrasound diagnosis, contact lenses for vision correction, spinal fixation system for orthopedic surgery, etc.
Class 4: Kit for monitoring spinal contact pressure, catheter for central circulatory system arteries, ventricular implant, spinal surgical injection, etc.Related Agency
Pharmaceuticals and Medical Devices Agency ([Link])