Directorate General of Pharmaceutical and Medical Devices
Publisher
Ministry of Health RI
Year
2023
ISBN
Dimension
Number of Pages
29
Description
In order to support the acceleration of business licensing which is mandated by Law No. 11 of 2020 concerning Job Creation, since mid-2022, several changes have been made in the CDAKB certification process, one of which is self-assessment. Self assessment is one of the requirements adapted from all clauses of the Regulation of the Minister of Health of the Republic of Indonesia Number 4 of 2014 concerning Good Medical Device Distribution Methods. Self-assessment aims to enable companies to independently assess the implementation of CDAKB before being evaluated by evaluators/auditors.