Guidelines for Classification of Medical Device

Requirement of Marketing Authorization for medical device
of new application comprises of administration and technical
document requirement, as follows:
1. Application Form
2. Form A is Administration
3. Form B is Product Information
4. Form C is Information of Specification and Product Warranty
5. Form D is Instruction for use
6. Form E is Post Market Surveillance

How to conduct a good clinical testing of medical device

Classification Process Time: 7 calendar days for all classes and types of services.

Evaluation Process Time:

Class A (I): 45 days

Class B (IIa): 90 days

Class C (IIb): 100 days

Class D (III): 120 days

Renewals/Variations (All Classes): 45 days

Fees (in Indonesian Rupiah - IDR): Initial Marketing Authorization:

Class A (I): Rp 1,500,000

Class B (IIa): Rp 3,000,000

Class C (IIb): Rp 3,000,000

Class D (III): Rp 5,000,000

Renewal/Variation of Marketing Authorization:

Class A (I): Rp 500,000

Class B (IIa): Rp 1,000,000

Class C (IIb): Rp 1,000,000

Class D (III): Rp 1,000,000

Notes: The timeline mentioned is in calendar days and applies to initial evaluations. Fees are regulated under Government Regulation No. 21 of 2013 concerning the type and tariff for Non-Taxed State Revenue (PNBP) by the Ministry of Health.

For Domestic Manufacturers (Local Products)
Eligibility: CFS can only be applied by the holder of the marketing authorization (izin edar).

Validity: The certificate is valid for 2 years from the date of issuance.

Purpose: Certifies that the medical device is legally marketed and sold in Indonesia.

Required Documents:

Application letter to the Director of Medical Device and PKRT Evaluation using company letterhead.

Complete product information (name, export name if any, registration number, ingredients, use, size/type, specs, packaging, labeling, destination country).

Valid production certificate.

Valid marketing authorization and approved labeling (including export labeling, if used).

Stamped declaration (Rp 6000) stating exported product is identical to the approved one in Indonesia (especially if product names differ).

For Imported Products (Distributors)
Responsibility: CFS application must be submitted by the distributor holding the marketing authorization.

Validity: Certificate is also valid for 2 years from issuance.

Purpose: Confirms that imported products are registered and legally sold in Indonesia.

Same CFS Requirements Apply: Similar documents and information as required for domestic products must be provided.

Procedures Granting Of Consent: Medical Devices Advertisements, In Vitro Diagnostic Medical Devices And Pkrt

Medical Device Information and Regulations - Guidelines 

https://regalkes.kemkes.go.id/index.php#home/Informasi/informasiAlkes