Certificate of Free Sale, hereinafter abbreviated to CFS, means a certificate issued by the appropriate agency of a country that certifies that the Medical Devices, In Vitro Diagnostic Medical Devices and PKRT have obtained Product License and have been free sale in the country. Based on the Minister of Health Regulation of the Republic of Indonesia Number 62 Year 2017 concerning the Distribution License of Medical Devices, In Vitro Diagnostic Medical Devices, and Household Health Supplies, the requirements for a Certificate of Free Sale are as follows:
- Trade name/brand name, issued by the authorized entity in the country of origin
- Statement of the registered product type
- Name and address of the manufacturer in the country of origin
- Validity period as stated on the health certificate/free sale certificate. If not specified in the appointment letter, the validity period shall not exceed 1 year from the date of issuance
Certificate of Free Sale for Domestic Products
The Certificate of Free Sale (CFS) for domestic products confirms that a domestic Medical Device, In Vitro Diagnostic Medical Device, or Household Health Supplies (PKRT) has received market authorization and is freely sold in Indonesia. The license holder submits the application for the Certificate of Free Sale (CFS) for domestic products. This certificate remains valid for 2 (two) years from the date of issuance.
Certificate of Free Sale for Imported Products
The Certificate of Free Sale (CFS) for imported products confirms that an imported Medical Device, In Vitro Diagnostic Medical Device, or Household Health Supplies (PKRT) has received market authorization and is freely sold in Indonesia. The distributor holding the market authorization submits the application for the Certificate of Free Sale (CFS) for imported products. This certificate remains valid for 2 (two) years from the date of issuance.
For manufacturers aiming to enter foreign markets, obtaining a CFS is typically obligatory. It assures importing countries that the products meet comparable safety and regulatory standards, facilitating smoother market entry and preventing potential delays and harm to their reputation.
Reference:
Minister of Health Regulation of the Republic of Indonesia Number 62 Year 2017
https://regalkes.kemkes.go.id/informasi_alkes/PMK_No_62.pdf
Guidelines for Export and Import Regulations of Medical Devices, In Vitro Diagnostic Medical Devices, and Household Health Supplies
https://regalkes.kemkes.go.id/informasi_alkes/Pedoman%20Ekspor%20Impor.pdf
