How to Get an Oximeter Distribution Permit in Indonesia?

The distribution of medical devices in Indonesia, including oximeters, is regulated under Law No. 36 of 2009 on Health and Minister of Health Regulation No. 62 of 2017 concerning the Distribution Permit for Medical Devices, In Vitro Diagnostic Medical Devices, and Household Health Supplies. All medical devices, including oximeters, must obtain a distribution permit before being marketed in Indonesia.

Oximeters: A Simple Way to Measure Your Blood Oxygen

Oximeters are small medical devices that measure the level of oxygen in your blood. They are non-invasive, meaning they don’t require any needles or incisions. Oximeters are commonly used in hospitals and clinics, but they are also available for home use

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Administrative Requirements

1. Production Certificate (for locally manufactured products)
   • Specifies the type of medical device permitted for production.
   • Category: General and Personal Hospital Equipment
   • Product Type: Cardiology Equipment
2. Medical Device Distributor License (IDAK)
   • Must include permission to distribute non-radiation electromedical devices.
3. Letter of Authorization (LoA)
   • Appoints a sole/exclusive agent or distributor.
   • Legalized by the Indonesian Embassy (KBRI) in the country of origin.
   • Must include the trade name and product type.
   • Valid for at least two years.
4. Certificate of Free Sale (CFS)
   • Confirms that the product is marketed in the country of origin.
   • Issued by the relevant authority in the country of manufacture.
5. Quality Management System Certification
   • ISO 9001 certification covering manufacturing/production of oximeters.
   • CE certification (if applicable) issued by a registered Notified Body.
6. Executive Summary
   • A brief review including device description, working mechanism, marketing history, intended use, indications, safety, and performance information.
7. Declaration of Conformity (DoC)
   • A manufacturer’s statement confirming compliance with applicable standards.
8. Trademark Patent Statement
   • Trademark certificate from the Directorate General of Intellectual Property.
   • A declaration agreeing to release the trademark if legally required.
9. Declaration of Authenticity of Documents/Data
   • A statement confirming the authenticity and accuracy of submitted documents.
   • Signed by the company’s authorized representative.

Technical Requirements

1. Raw Material Composition
   • Front panel: ABS/Polycarbonate
   • Rear panel: ABS/Polycarbonate
   • Keypad: Rubber
   • Oximeter cable: Rubber
2. Finished Product Specifications
   • Oxygen Saturation Range (%SpO2): 0% – 100%
   • Pulse Rate Range: BPM (beats per minute)
   • Display: LED digits, Tricolor (red, green, amber)
   • Accuracy: SpO2 (Standard Deviation)
   • Additional Features: Pulse rate, temperature, humidity, altitude, power requirements, storage, recharge, dimensions, memory, weight (~1 kg), warranty.
3. IEC 60601 Compliance
   • Electrical safety certification issued by a third party for patient safety.
4. Quality Control (QC) Testing
   • Physical inspection: Free from major scratches, dirt, or defects.
   • Functionality: SpO2, pulse rate, and alarm verification.
   • Calibration: Pulse rate and SpO2 settings tested.
   • Sensor functionality: Verification with a 97% finger phantom.
   • Alarm indicators: Pulse quality, sensor status, pulse strength.
   • Light activation: The device should illuminate when in use and turn off when removed.

Labeling Requirements

Oximeter products must include at least the following information:

• Distribution permit number
• Trade name/brand
• Product type
• Device image
• Device specifications
• Manufacturer’s name and address
• Importer’s name and address (if applicable)
• Batch/serial number for traceability

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Registration Process

1. Submission of Application
   • Complete administrative and technical requirements.
2. Risk Classification & Payment
   • Determine risk classification and pay the registration fee within seven days.
3. Evaluation by Regulatory Team
   • The review team assesses documentation and compliance.
4. Draft Permit Review
   • Applicants review the draft permit and provide corrections within 24 hours if needed.
5. Document Deficiency Notification
   • Applicants must complete any missing documents within ten days.
6. Re-evaluation
   • The review team reassesses the submission after document completion.
7. Rejection or Approval
   • If requirements are unmet, a rejection letter is issued.
   • If all conditions are met, the distribution permit is granted.

Permit Issuance

Once the safety, quality, and efficacy evaluations are completed, the Minister of Health issues the distribution permit through the Directorate General of Pharmaceuticals and Medical Devices.

Permit Format:

• Domestic Products: KEMENKES RI AKD XXXXXXXXXX
• Imported Products: KEMENKES RI AKL XXXXXXXXXX

Ensuring compliance with these regulations is crucial for manufacturers and distributors to successfully market oximeters in Indonesia.

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INSIGHTOF offers comprehensive regulatory services to facilitate market entry in Indonesia, specializing in BPOM and Kemenkes product registration with expert guidance every step of the way.

For any inquiries, please feel free to contact us at marketing@insightof.co.id.