Important Changes and Compliance Requirements for Medical Device Distributors
In accordance with Government Regulation Number 5 of 2021 regarding the Implementation of Risk-Based Business Licensing and the Minister of Health Regulation Number 14 of 2021 concerning Standards for Business Activities and Products in the Implementation of Sector Risk-Based Business Licensing in the Health Sector, a new announcement has been made to ensure compliance with current regulations.
Key Points of the Announcement
1. Mandatory Business License Number (NIB)
Every medical device distribution business is required to obtain a Business License Number (NIB) under KBLI 46691. This classification pertains to the wholesale trade of laboratory equipment, pharmaceutical equipment, and medical devices for humans, covering distributors and branches of medical device distributors. The standards regulating these requirements are crucial for conducting business in this sector.
2. Adjustment of Existing Licenses
Business actors currently holding a Medical Device Distributor License (IPAK) under the Minister of Health Regulation Number 1191/MENKES/PER/VIII/2010 of 2010 concerning the Distribution of Medical Devices must update their permits to align with the new regulations.
3. Submission of IDAK Applications
IDAK applications should be submitted through the OSS RBA system accessible via the official website www.oss.go.id. This system is integrated with the Regalkes system according to the Single Sign On (SSO) mechanism.
4. Application Procedures
Detailed procedures for submitting applications via the OSS system can be found at https://oss.go.id/panduan. Additionally, materials related to fulfilling IDAK requirements are available at https://drive.google.com/drive/folders/1ltHUcOHnuvQCDSyzul1FODFVf8a1JiDX
5. CDAKB Certification Requirement
Every medical device distributor is required to have a CDAKB (Good Distribution Practices for Medical Devices) certificate in accordance with the Minister of Health Regulation Number 14 of 2021.
This announcement serves as a crucial reminder for all medical device distribution business actors to review and adjust their compliance practices according to the latest regulations. Ensuring that all necessary permits and certifications are up to date is essential for the continued operation and legality of their business activities.
For further details and guidelines, business actors are advised to refer to the provided resources and links. Compliance with these updated regulations will not only ensure adherence to legal standards but also contribute to the overall safety and quality of medical device distribution.
Reference:
https://regalkes.kemkes.go.id/index.php/home/fileDownload/BERITA_FILE.pdf/1000934
