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

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