December 17, 2019

Changing some information after device approved can be done through amendment which has shorter timeline for approval. However, not all of the changes in the device can apply for amendment. Indonesia Ministry of Health elaborate specific criteria for the type of changes that can be reported as amendment to MoH. Other than below changes, the application will be treated as new application
A. Size, including:

  •  Addition or reduction of product content and / or size

B. Packaging, including:

  •  Increase or decrease packaging size
  • Addition or reduction of packaging types
  • Design change in package shape
  • Changes in packaging material

C. Marking

  • Language changes in the instructions for use (instructions for use) and / or packaging
  • Changes to the logo or symbol, including the halal logo, quality management system, CE, and company logo.
  • Changes to product expiration date if stated in the designation
  • Changes to product code / type
  • Changes in storage temperature
  • Improvements to the product name
  • Designation of designation markings (color, image, text and layout)

D. Accessories / attachments on marketing authorization:

  • Accessories
  • Type
  • Product code
  • Product Size

E. Name and / or address of the representative authorized by the Manufacturer / Manufacturer, including:

  • Change in the name and / or legal address of the manufacturer
  • Change in legal entity
  • Changes in manufacturer's address due to changes in urban planning
  • Change in manufacturer's name as long as the manufacturer's address does not change location / move location
  • Change of distributor's name if the NPWP and NIB have not changed
  • Change of address of the distributor (distributor) who moved the province

F. Writing on marketing authorization (typo)


1) Pedoman Pelayanan Izin Edar PKRT Bilingual
Guidance Socialization Material