Safety certification

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Domestic certification

Medical device certification

Manufacture of medical device, permission and declaration of import are classified into the following 4 categories.
  • Class1 medical device : get the manufacturing authority by reporting only
  • Class2 medical device : certified through the review of technical document by private institutions
  • Class3 medical device : approved through technical document review by the Ministry of Food and Drug Safety
  • Class4 medical device : approved through STED(Summary Technical Documentation) review by the Ministry of Food and Drug Safety
Medical device test and inspection items include the following :

General medical equipment, surgical operation apparatus, medical treatment chamber, life-support system, alternative container for internal organs function, diagnostic apparatus, medical stimulation-generating machinery, mechanical equipment for surgical procedure, wheel stretchers, biological phenomenon measuring device, diagnostic devices of outside body, medical reflector, mechanical equipment for medical treatment, syringes and needles, mechanical equipment for dental treatment, lens for vision correction, hearing aid, medical substance generator, medical suppliers for insertion into the body, human tissue or functional replacement, medical supplies of outside body, contraceptive device, dental alloy, ingredients for dental treatment, reagents for diagnostic medical devices of outside body

In the certification agency of medical device test and inspection items,
HowSolution will be the proper partner of your growing.