Medical Device Certificate

The era of globalization has led to the ease of entry and exit of goods including medical devices and Household Health Supplies (PKRT). Rapidly developing medical device technology has caused the public to need information for individual, company, or public facility needs. Product information is also needed to carry out the import and export of medical devices, and PKRT is needed to carry out the registration process.

Definition

Certificate of Exportation is a certificate issued for the export of locally produced medical devices or household health products that are not sold or registered within the territory of Indonesia.

Certificate of Free Sale is a certificate issued by the Minister stating that a medical device or household health product has obtained marketing authorization or has been freely sold in Indonesia.

Special Access Scheme is a permit for the inclusion of medical devices or household health products into the Indonesian territory through a special line mechanism for the purpose of research, assistance, grants, donations, and individual use in certain cases.

Certificate of Sample Importation is necessary for compliance with Product Approval. This certificate enables the importation of medical devices and household health product samples for testing purposes as a requirement for obtaining Product Approval. Examples of products include disposable syringes, condoms, sanitary napkins, baby diapers, adult diapers, and HIV testing reagents.

Certificate Import for Raw Materials is a document meant to inform Customs that the imported goods are raw materials intended for use in 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 is a certificate intended to inform Customs that the imported products are spare parts of a medical device or household health product, which already has product approval from the Ministry of Health.

Product Information Certificate for a Company/Individual is a certificate intended to provide information on whether a product belongs to the category of medical devices or household-health products, as required by the company/individual. It is not used for expenditure in the Customs.

A Customs Import Certificate (SKIBC) is intended to provide information to Customs to determine if a product is classified as a medical device or PKRT category.

Letter of Advertisement Approval is a permit letter given by the Indonesia Ministry of Health through the Directorate of Medical Devices and Household Health Product Evaluation for medical devices and household health products that will be advertised in the media.

A certificate is provided to companies with a distribution permit for Medical Devices, In Vitro Diagnostic Medical Devices, and PKRT, which will be distributed in promotional packaging.

Grace Period/Stock Exhaustion Certificate: This certificate is given to a company to deplete old stock of a product solely for the purpose of relabeling.

1. Export-Import Notification Letter

• Certificate of import of raw materials for products
• Certificate of sample importation in the framework of a 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 of Research Use Only

2. Product Information Certificate

There are several requirements that must be understood for the general and specific product information of SUKET:

General Requirements:

1. Application letter addressed to the Director of Assessment of Medical Devices and PKRT uses letterhead (if company) and includes the name of the product.
2. Application letter addressed to the Director of Assessment of Medical Devices and PKRT uses letterhead (if company) and includes the name of the product.

Special Requirements

Brochures and Product Information include:

• Tool Description
• Description and features of the tool.
• Purpose of use or Indication.
• Instructions for the use of materials/raw materials.

For certain products that have functions or specifications such as medical devices/PKRT (if needed):

• Declaration of Conformity (DoC)
• Manufacturer/factory ISO Certificate
• Certificate of Free Sale (CFS)

3. Import Certificate (Customs and Excise)

General Requirements:

• Application letter addressed to the Director of Medical Device Assessment and PKRT using letterhead (if the company) and includes the name of the product
• Notice on Import of Goods (PIB).
• Invoices.
• Airway bill/bill of lading (AWB).
• Notice of Prohibited/Restricted Goods Notification (NPBL).

Special Requirements

• Brochure/catalog/other supporting data regarding the product: -Description of the tool; Tool description and features; Purpose of use or Indication; Instructions for the use of materials/raw materials.
• For certain products that have functions or specifications such as medical devices/PKRT (if required): -Declaration of Conformity (DoC); ISO Certificate Manufacturer/Producer;Certificate of Free Sale

4. Notification Letter

• Promotional Certificate (Alkes, IVD Medical Devices, and PKRT that have been has a distribution permit, distributed in the context of promotion)
• Certificate of Marking Change (notification of changes made) administrative nature of all products that do not affect safety, quality, product benefits)
• Letter of Approval for the end of the remaining stock (can circulate the product with the old marking within a certain period of time due to tag change)[/list]

Requirements

• Application letter using company/institution letterhead.
• Current distribution permit along with the approved marking.

5. Promotion Certificate

• Application letter includes: product name and distribution license number, promotional objectives, promotion plans/details
• Promotional marking design
• Promotion time (maximum 3 months)

6. Approval Letter for Exhaustion of Remaining Stock

• The application letter includes the name of the product, an explanation regarding the purpose of stock-out or changes to distribution permits, and an analysis of the calculation of the expiration time and the amount of stock
• Masa berlaku surat persetujuan adalah 3 bulan

Online Application Process:

1. The applicant submits a Certificate of Product Information (SKIP)/ Certificate of Customs and Excise Information (SKIBC) through http://esuka.binfar.kemkes .go.id/portal, http://esuka.binfar.kemkes .go.id/portal,
2. The evaluator checks the completeness and correctness of the file, if it does not match it will be rejected, if it is appropriate then the process will continue.
3. Complete & appropriate files will be given a Payment Order (SPB).
4. The applicant pays according to the SPB/PNBP and uploads the original proof of payment (PNBP fee Rp. 250,000).
5. Files are processed further and the process of issuing certificates (3 Day Service)
6. The certificate of publication can be downloaded at the completion of the document option (Validity period 2 years)