Skip to main content

Class B — Low to Moderate Risk Devices

Class B covers devices that present a low to moderate potential to cause harm. They require a standard registration with more complete documentation than Class A but without the full clinical evidence demands of Class C and D.

Examples of Class B Devices​

  • Hypodermic needles and syringes
  • Sterile surgical gloves
  • Infusion sets and IV catheters
  • Urinary catheters
  • Blood pressure monitors (electronic)
  • Powered hospital beds
  • Contact lenses (daily wear, non-corrective)
  • Dental instruments (non-invasive surgical)
  • Pulse oximeters

Registration Pathway​

Class B follows the standard registration pathway via Regalkes. Key features:

  • Full ASEAN CSDT dossier required
  • ISO 13485 certification mandatory for imported products
  • Clinical evidence: literature-based clinical evaluation report is typically sufficient; local clinical data generally not required
  • Review timeline: approximately 3–6 months for complete submissions

Documentation Requirements​

DocumentRequired for Class B?
Letter of Authorization (LoA) — apostilledYes
Free Sale Certificate (CFS/FSC) — apostilledYes
GMP CertificateYes
ISO 13485 CertificateYes (mandatory for imports)
Device description, intended use, IFUYes
Labeling (Bahasa Indonesia compliant)Yes
Risk Analysis (ISO 14971-based)Yes
Clinical evidence (literature review)Yes
Biocompatibility / sterility data (if applicable)Yes

Halal Labeling Deadline​

Class B devices must comply with Halal labeling requirements by 17 October 2029 under Government Regulation 42/2024.