January 16, 2020
In order to maintain the safety and efficacy of a medical device, a surveillance system is needed. Therefore, medical device distributors in Indonesia are recommended to comply with CDAKB / Good Distribution Practice of Medical Device.
In connection with this, the Ministry of Health conducts supervision of medical device in the following ways:
1. Sampling and Testing
Sampling of representative Medical Devices and Household products in distribution facilities, health facilities and other facilities for testing one or more parameters in accordance with the agreed conditions at the time of obtaining marketing authorization license. This is done when the product is widely used by the public, products that have just received a Marketing Authorization Number, and products that have experienced an adverse event.
2. Advertising and Labeling Control
This is in order to prevent misleading due to advertising or labelling information. Requirements needed in advertising and labeling are Objectif, Ethics of decency, and using language that does not lead to multiple interpretations. Also, MoH has more concern on the advertisement on internet, built in advertisement, advertisement with prizes or advertisement with testimonial from health professional.
3. Vigilance System Oversight
Adverse events can occur. Therefore, the Ministry of Health calls on business persons, health service facilities, and the general public to take part in supervising so that this immediately gets a treatment or corrective action.
4. Audit of technical and clinical information
The Ministry of Health also evaluates technical and clinical information.
Socialization of Medical Devices Supervision
CDAKB, Medicaldevice, Distributor, GDPMD