The hCG Rapid Pregnancy Test falls under the category of in vitro diagnostic (IVD) medical devices, used to detect the hormone human chorionic gonadotropin (hCG) in urine, which indicates pregnancy. Before it can be distributed and used in Indonesia, this device must go through a registration process with the Ministry of Health (Kemenkes) to ensure its safety, quality, and effectiveness.
This article will provide a comprehensive guide on the stages, requirements, and necessary documents for registering hCG rapid pregnancy tests in Indonesia, in accordance with the applicable regulations.
What is an hCG Rapid Pregnancy Test?
The hCG Rapid Pregnancy Test is an in vitro diagnostic medical device (IVD) used to detect the human chorionic gonadotropin (hCG) hormone in urine, which is an early sign of pregnancy.
This test comes in three forms:
- Strip – the simplest form, dipped directly into a urine sample.
- Cassette – uses a pipette to drop urine onto the test area.
- Midstream – used directly in the urine stream.
The hCG hormone can be detected in urine from the first week of pregnancy at levels between 5–50 mIU/mL, increasing to 200,000 mIU/mL during the first trimester.
🔍 Features of hCG Rapid Pregnancy Test:
- Easy to use—no special equipment required.
- Suitable for both medical professionals and general users.
- High sensitivity, capable of detecting low levels of hCG.
- Sealed packaging with silica gel to maintain product quality.
📄 Required Documents for Kemenkes Registration
- Production Certificate(for local products)
- Must specify the category: Clinical Chemistry and Toxicology Equipment.
- Mention the product as hCG Rapid Pregnancy Test or a similar recognized name.
- Medical Device Distribution License (IPAK)
- Must include the product category: In Vitro Diagnostic Medical Device.
- Letter of Authorization (LOA)(for imported products)
- A letter from the manufacturer appointing the applicant as the sole/exclusive agent or distributor.
- Must be legalized by the Indonesian Embassy in the country of origin and valid for at least 2 years.
- Certificate of Free Sale (CFS)
- Confirms the product is legally marketed in the manufacturer’s home country, issued by the relevant authority.
- ISO Certification
- ISO 13485: Quality management system certification for medical devices.
- If applicable, include ISO 9001 or CE Mark from a recognized Notified Body.
- Executive Summary
- A product overview, including the description, working mechanism, intended use, safety, and performance information.
- Declaration of Conformity (DoC)
- A declaration from the manufacturer that the product complies with applicable standards.
- Trademark & Document Authenticity Statements
- Proof of trademark ownership or a declaration to release agency rights if a more rightful party emerges.
- A signed statement that all submitted documents are original and authentic.
Note: If you want sample of product you can contact us
🔬 Technical Product Requirements:
- Material Components
Main materials used in the hCG Rapid Pregnancy Test:
| Component | Main Material |
|---|---|
| Gold Conjugate | Mouse anti-beta hCG antibody, colloidal gold |
| Test Line | Mouse anti-alpha hCG antibody |
| Control Line | Goat anti-mouse IgG antibody |
| Membrane | Nitrocellulose membrane |
| Gold Conjugate Pad | Polyester |
| Sample Pad | Glass fiber |
- Performance Testing (According to ISO 13612:2002)
- Analytical Sensitivity: Measures the lowest concentration of hCG detectable in urine.
Example: If the Limit of Detection (LoD) is 25 mIU/mL, it should be validated with test concentrations of 0, 12.5, 18.75, 25, 50, and 100 mIU/mL across 30 samples. - Analytical Specificity: Ensures no cross-reactivity with similar hormones (e.g., FSH, LH, TSH).
- Interference Testing: Ensures the test is not affected by substances in urine, such as:
- Over-the-Counter (OTC) drugs (e.g., acetaminophen, ampicillin)
- Chemicals (e.g., ascorbic acid, caffeine)
- Biological substances (e.g., albumin, glucose, bilirubin)
- pH range of 4–9
- Analytical Sensitivity: Measures the lowest concentration of hCG detectable in urine.
- Stability Testing
- Determines product shelf life using real-time stability testing as per ISO 23640:2013.
- Certificate of Analysis (COA)
- A quality control (QC) report from the manufacturer, including:
- Product dimensions
- Absorption rate
- Performance characteristics
- Storage conditions
- Expiration date
- A quality control (QC) report from the manufacturer, including:
Mandatory Product Label Information
The product label for hCG Rapid Pregnancy Test must include:
- Medical Device Registration Number (from Kemenkes)
- Product trade name/brand
- Device type and intended use
- Manufacturer’s and importer’s name and address
- Batch number or serial code for traceability
- Expiration date
- Statement: “Single Use Only”
- Statement: “For In Vitro Diagnostic Use” or “IVD”
Example
How can INSIGHTOF help?
INSIGHTOF specializes in assisting with medical device registration in Indonesia. With a proven track record of over 430 successful registrations, we guide you through every step—ensuring smooth compliance with Kemenkes regulations. Let us help you bring your products to the Indonesian market!
For any inquiries, please feel free to contact us at marketing@insightof.co.id.
