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