Indonesia: Update on ANTRIAN Consultation Guidelines, Product Change Criteria and Fee
MOH Indonesia published the Guideline for Consultation with MOH Directorate Medical device and House-hold product on 24 December 2019, for consultation via email and using the ANTRIAN online system.
MOH Indonesia also announced on 30 October 2019 on the Fee changes to renewal with amendment, based on the government regulation PP No. 64 of 2019 on 17 October 2019, replacing PP No. 21 of 2013. Details on the product amendment or change criteria were provided.
Medical device registration fee
Medical device amendment or change criteria
1. Size including addition or reduction of product content and/or size
2. Packaging including packaging size, types, shapes, material– Changes in packaging material
3. Marking, changes on: – Language in the instructions for use and/or packaging – Logo or symbol, including the halal logo, quality management system, CE, and company logo. – Expiry date format – Product code/type – Storage temperature – product name improvement – Marking design (color, image, wording and layout)
4. Accessories/Attachment on Marketing Authorization License – Accessories, type, Product code, Product Size
5. Name and/or address of the representative authorized by the Manufacturer, including changes on: – Name and/or address of the legal manufacturer
– Legal entity
– Manufacturer’s address of the manufacturer due urban planning
– Manufacturer’s name, provided that no location shift nor change
– Distributor’s name, provided that no change to Tax ID number (NPWP) & Business Permit number (NIB)
– Distributor’s address, when shifted province
6. Wording on Marketing authorization license
House-hold product amendment or change criteria
· Size (for specific products)
· Principal’s name and/or address that is not an acquisition, without a change in manufacturer’s name for the imported house-hold product.
· Manufacturer’s name without changes to address and ownership for local house-hold product
· Other changes, that not affecting specifications and claims for the PKRT.
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