Circular Permit Requirements for Class A Medical Device Notifications
PERMENKES NUMBER 14 YEAR 2021 CONCERNING Activity Standards
Businesses and Products in the Implementation of Health Sector Risk-Based Business Licensing
- Distribution permit for notification is distribution permit for certain Class A medical devices and PKRT class 1 and 2 notifications with simplification of distribution permit requirements.
- Class A Medical Devices are medical devices that cause low risk based on the risk posed by the use of Medical Devices on patients
- Certain class A medical devices are home-use class A medical devices that can be used independently without requiring expertise Specialists/health workers, not sterile medical devices, and not In Vitro Diagnostic medical devices
Administrative Data Requirements
- Production Certificate / Standard Certificate (for repackaged AKD and AKL products)
- Distribution Certificate / IDAK (for distributors)
- Letter of Authorization (LOA) legalization of the Indonesian Embassy (AKL) or Letter of Appointment Notary legalization (AKD)
- Certificate of Free Sale (CFS) (for AKL products)
- Certification and documents stating conformity to product standards,
safety, effectiveness and quality system requirements in design and processes
manufacture (ISO 9001, ISO 13485, CE certificate)
- Standards used and evidence of conformity to these standards. Declaration of Conformity from the factory. (DoC/Statement of conformity of standards)
- Brand Patent Statement/Affidavit Dismissing Agency
- Statement letter that the uploaded document/data is original and correct
- Integrity Pact Letter
