Post-Marketing Surveillance

Indonesia Post Market Control Regulation
Regulation No. 36/2009:
Article 196: Every person who intentionally produces or distributes pharmaceutical preparations and / or medical devices that do not meet the standards and / or security requirements, efficacy or benefits, and quality is punished with a maximum of 10 (ten) years imprisonment and a maximum fine of Rp.1,000,000,000 (one billion Rupiah).

Article 197: Every person who intentionally produces or distributes pharmaceutical preparations and / or medical devices that do not have product approval / marketing license / AKL / AKD as referred to in Article 106 paragraph (1) shall be punished with a maximum of 15 (fifteen) years imprisonment and a maximum fine of Rp1,500,000,000 , 00 (one billion five hundred million rupiah).

Article 98 Point 3: Regarding procurement, storage, processing, promotion, distribution of pharmaceutical product and medical devices should be meet with service quality standards which stipulated by government regulations.

Production and Distribution Facilities Control

E-Report

is an application built to facilitate public services in the process of reporting of medical device manufacturers as well as reporting the result of distribution (distributor) by medical device dealer.

This system is a control of the possibility of using illegal medical devices that contain information on products which has produced and distributed by the manufacturers to local distributors before the products reached in the end users. Some of information that can be find through E-Report system include: Manufacturing license information (for local manufacturer), Distribution license information (for local distributors), Sales channel partner information, Lot / Batch product information, and product serial number. This information should be provided by local manufacturer or distributor before their release the product to the end users or sale channel partner.

Post Market Surveillance

Post market surveillance is carried out by the government in order to check the suitability of the quality, safety, and performance of the equipment during distribution and the conformity assessment of the data which was submitted during product registration. To control this program, the government carries out periodically through monitoring of manufacturer / distributor facilities, Quality system audit, products sampling in the market.

Our Services:

Electronic Reporting (E-Report)
Product Complaint and Recall
Field Safety Corrective Action (FSCA)