Classification of Medical Devices and Household Appliances

CLASSIFICATION OF MEDICAL DEVICES AND HOUSEHOLD APPLIANCES 

MEDICAL DEVICES 

Class I

Medical devices whose failure or missuse of the product will not cause serious effect. The evaluation of this product merely focused on the quality of product. 

Example : Toothbrush, Dental Flos, Bandage, Ice bag, etc.

Class IIa

Medical devices whose failure or missuse of the product may cause several adverse effect but will not cause a serious accident. These medical devices should comply with the requirements but no need to have a clinical test report.

Example : AC powered dinamometer, reflex hammer, Wheel chair, etc.

Class IIb

Medical Devices whose failure or missuse of the product can cause a significant adverse effect on the patient but will not cause a serious accident. These medical devices should comply with the requirements including the safety assessment but no need of clinical test report. 

Example : Contact lenses, ophthalmic laser, etc.

Class III

Medical Devices whose failure or missuse of the product will cause a serious adverse effect to the patient or physician/operator. These medical devices should comply with the requirements including the safety assessment and clinical test report. 

Example : ventricular by pass device, silicon gel filled breast, prefilled syringe, etc.

Household appliances / PKRT (Perbekalan Kesehatan Rumah Tangga)

Class I (Low risk)

Household appliances whose failure or missuse of the product will not cause serious effect such as iritation, corrosion, carsinogenic. These products should fill out a registration form without any laboratory test report. 

Example : Cotton, Cotton bud, tissue, etc.

Class II (Middle risk)

Household appliances whose failure or missuse of the product may cause iritation, or corrosion but not carsinogenic. these products should fill out a registration form and must comply with the requirements along with the laboratory test report. 
Example : Detergent, Car Freshener, Hand sanitizer, etc.

Class III (High Risk)

Household appliances which contain pesticide where the use of it may cause serious adverse effect such as carsinogenic. These products must fill out a registration form and should comply with safety requirements along with the laboratory test result and approved by the commission of Pesticide usage.

Example : Mosquito reppelent, Anti mosquito coil, Bug spray (insecticide), etc.