Product Registration

Medical Devices is one of the resources in the health sector in addition to the funds, personnel, medical supplies, pharmaceutical and health care facilities and technologies are used to conduct health efforts undertaken by the government, local government, and / or community. Medical devices is one component in the health service in Indonesia.

In Law No. 36 Year 2009 on Health stated that the pharmaceutical preparation and medical devices can only be released after obtaining marketing authorization. Medical devices used in health care should be ensured safe, quality and efficacy/performance. This can be obtained using medical devices that already have a marketing authorization that has been through the evaluation process.

In order to ensure the safety, quality and efficacy/performance of medical devices and Household-Health Product distributing in Indonesia, the Directorate of Medical Devices and Household-Health Product (PKRT)Evaluation to guarantee medical devices and Household-Health Product in circulation meets the requirements.

With the harmonization at the level of ASEAN in the field of medical devices, and the publication of guidelines for medical devices at the ASEAN (AMDD / ASEAN Medical Device Directive) then Indonesia as the country actively participate in ACCSQ-MDPWG (Asean Conformity Committee for Standard and Quality Medical Devices product Working Group) has adopted the ASEAN Medical Device Directive to be adjusted and implemented in the regulation of medical devices and PKRT in Indonesia.

Medical Device are divided into four classes in accordance to the risk that may be arising. Class A (low risk), class B (low to medium risk), class C (medium to high risk) and class D (high risk).

To ensure the safety, quality, and performance, each medical device then first have to pass pre-market evaluation process. In carrying out the duties and functions of the pre-market, the Directorate of Medical Device and Household-Health Product Evaluation provide public services that are efficient, effective, transparent and accountable.

TYPE OF SERVICES OF THE MEDICAL DEVICE MARKETING AUTHORIZATION

Services of the Medical Device Marketing Authorization consists of:

  1. New Product of Medical Device
  2. Renewal of Medical Device
  3. Variation of Medical Device
  4. Renewal with Variation of Medical Device

Marketing Authorization of medical device is approved by the Minister of Health through Director General of Pharmaceutical and Medical Device after fulfilling evaluation process and is declared to meet all requirements of safety, quality, and performance.

TIMELINE

Requirement and length of time to obtain the Marketing Authorization is depends on the risk classification of the medical device. Duration of Marketing Authorization process is calculated since obtaining the fixed receipt from online registration.

In order to implement transparent and accountable services there has been a change from manually organized at the first than become online system, in which the application system may not be in offline position due to calculating of service day use calendar day provide by online system.

Type of ServiceClassification Process (day)Evaluation Process* (day)
Medical Device Marketing Authorization Class A (I)
745
Medical Device Marketing Authorization Class B (IIa)
790
Medical Device Marketing Authorization Class C (IIb)
7100
Medical Device Marketing Authorization Class D (III)
7120
Renewal / Variation of Medical Device Marketing Authorization Class A (I)745
Renewal / Variation of Medical Device Marketing Authorization Class B (IIb)745
Renewal / Variation of Medical Device Marketing Authorization Class C (IIb)745
Renewal / Variation of Medical Device Marketing Authorization Class D (IIb)745