The era of globalization has facilitated the movement of goods, including medical devices and Household Health Supplies (PKRT). Rapid advancements in medical device technology have created a demand for information to meet the needs of individuals, companies, and public facilities. This product information is essential for importing and exporting medical devices and PKRT, as well as for the registration process.

Definitions

• Certificate of Exportation: This certificate is issued for the export of locally produced medical devices or household health products that are not sold or registered within Indonesia.
• Certificate of Free Sale: Issued by the Minister, this certificate confirms that a medical device or household health product has received marketing authorization or is freely sold in Indonesia.
• Special Access Scheme: This permit allows the inclusion of medical devices or household health products into Indonesia through a special mechanism for research, assistance, grants, donations, or individual use in specific cases.
• Certificate of Sample Importation: This certificate is required for compliance with Product Approval. It enables the importation of medical device and household health product samples for testing, necessary for obtaining Product Approval. Examples include disposable syringes, condoms, sanitary napkins, baby diapers, adult diapers, and HIV testing reagents.
• Certificate of Import for Raw Materials: This document informs Customs that the imported goods are raw materials intended for the production of medical devices or household health products that have already received product approval from the Ministry of Health.
• Certificate of Import for Spare Parts: This certificate indicates to Customs that the imported products are spare parts for a medical device or household health product that has received product approval from the Ministry of Health.
• Product Information Certificate for a Company/Individual: This certificate provides information on whether a product falls under the category of medical devices or household health products, as required by the requesting company or individual. It is not used for Customs clearance.
• Customs Import Certificate (SKIBC): This certificate provides information to Customs to classify a product as a medical device or PKRT category.
• Letter of Advertisement Approval: This permit is issued by the Ministry of Health through the Directorate of Medical Devices and Household Health Product Evaluation for advertising medical devices and household health products in the media.
• Grace Period/Stock Exhaustion Certificate: This certificate allows a company to deplete old stock of a product solely for the purpose of relabeling.

Types of Certificates

1. Export-Import Notification Letter:
   • Certificate of import of raw materials for products
   • Certificate of sample importation for product approval
   • Certificate of Power of Attorney for Import
   • Free-to-Sell Certificate for Domestic Products
   • Free Sale Certificate for Imported Products
   • Export Notification Certificate
   • Certificate of Import (Customs and Excise)
   • Certificate for Research Use Only
2. Product Information Certificate:
   • General Requirements:
     • Application letter addressed to the Director of Medical Device Assessment and PKRT, using company letterhead and including the product name.
   • Special Requirements:
     • Brochures and product information, including:
       • Tool description
       • Features of the tool
       • Purpose of use or indications
       • Instructions for using materials/raw materials
     • For certain products with specific functions or specifications, additional documentation such as Declaration of Conformity (DoC), Manufacturer/Factory ISO Certificate, and Certificate of Free Sale (CFS) may be required.
3. Import Certificate (Customs and Excise):
   • General Requirements:
     • Application letter addressed to the Director of Medical Device Assessment and PKRT, using company letterhead and including the product name.
     • Notice on Import of Goods (PIB)
     • Invoices
     • Airway bill/bill of lading (AWB)
     • Notice of Prohibited/Restricted Goods Notification (NPBL)
   • Special Requirements:
     • Brochures/catalogs or other supporting data regarding the product, including descriptions, purposes, and usage instructions. Additional documentation may include Declaration of Conformity, ISO Certificate, and Certificate of Free Sale.
4. Notification Letter:
   • Promotional Certificate for Alkes, IVD Medical Devices, and PKRT that have a distribution permit.
   • Certificate of Marking Change for administrative changes that do not affect safety or quality.
   • Letter of Approval for the exhaustion of remaining stock to circulate products with old markings within a specified period.
5. Promotion Certificate:
   • Application letter including product name, distribution license number, promotional objectives, and plans.
   • Promotional marking design
   • Promotion duration (maximum of 3 months)
6. Approval Letter for Exhaustion of Remaining Stock:
   • Application letter should include the product name, reason for stock depletion, and analysis of expiration time and remaining stock. The validity of this letter is 3 months.

Online Application Process

1. The applicant submits a Certificate of Product Information (SKIP) or Certificate of Customs and Excise Information (SKIBC) through http://esuka.binfar.kemkes.go.id/portal.
2. The evaluator checks the completeness and correctness of the submitted files. Incomplete submissions will be rejected; complete submissions will proceed.
3. Complete and correct files will receive a Payment Order (SPB).
4. The applicant pays the applicable fee (PNBP) of Rp. 250,000 and uploads the original proof of payment.
5. The files will be processed, and the certificate will be issued within 3 days.
6. The certificate can be downloaded upon completion of the process (valid for 2 years).