Medical Device Registration for Soft Contact Lenses in Indonesia

1. Soft Contact Lenses as Medical Devices

Soft contact lenses are explicitly classified as medical devices in Indonesia because they are used directly on the eye and function for vision correction as well as therapeutic and cosmetic purposes.

Unlike eyeglasses, which are external devices, soft contact lenses come into direct contact with the cornea, resulting in a higher risk level and stricter regulatory control.

The typical registration details are as follows:

• Soft Contact Lenses
  • Category: Ophthalmic Devices
  • Subcategory: Therapeutic Eye Devices
  • Type: Soft (Hydrophilic) Contact Lens
  • Medical Device Class: Class 2
  • Risk Class: Class C (moderate risk)
  • Example of variants: Black, grey, brown, blue

Based on this classification, soft contact lenses must obtain a Medical Device Distribution License (Nomor Izin Edar / NIE) from Kemenkes RI before they can be manufactured, imported, or distributed in Indonesia.

2. Medical Device Registration Process in Indonesia

The registration of soft contact lenses is conducted through Regalkes (Online Medical Device & PKRT Registration System) (Registrasi Alat Kesehatan & PKRT Online) managed by Kemenkes RI.

The main stages include:

a. Medical Device Classification

• Soft contact lenses are classified as Class 2 – Risk Class C

b. Technical Documentation Requirements

Commonly required documents include:

• Product information and technical specifications
• Quality and safety test reports
• ISO 13485 certificate of the manufacturer
• Certificate of Free Sale (CFS) for imported products
• Label and IFU (Instructions for Use)

c. Submission via Regalkes

• Online document submission
• Payment of PNBP (Non-Tax State Revenue)

d. Evaluation and Issuance of NIE

• Technical evaluation by Kemenkes RI
• Upon approval, issuance of the Medical Device Distribution License (NIE), allowing legal distribution in Indonesia

3. Halal Certification Requirement for Class 2C Medical Devices

Referring to Law No. 33 of 2014 on Halal Product Assurance and Government Regulation No. 39 of 2021, medical devices are included within the scope of mandatory halal certification, including soft contact lenses.

This requirement is particularly relevant because soft contact lenses:

• Contain polymers, coatings, pigments, and supporting solutions derived from various sources
• Are used directly on the human body

4. Halal Certification Process for Soft Contact Lenses

Halal certification is administered by BPJPH (Halal Product Assurance Organizing Agency) under the Ministry of Religious Affairs, in collaboration with accredited Halal Inspection Bodies (LPH).

The process includes:

a. Raw Material Assessment

• Evaluation of all soft contact lens materials (polymers, monomers, colorants, coatings)
• Verification of material traceability to ensure freedom from non-halal substances

b. Manufacturing Process Evaluation

• Review of manufacturing procedures
• Prevention of cross-contamination with non-halal materials

c. Facility Inspection & Halal Assurance System (SJPH)

• Implementation of a Halal Product Assurance System (SJPH)
• Documented procedures and staff training

d. Audit & Halal Certificate Issuance

• On-site audit by accredited LPH
• Halal Certificate issued by BPJPH

The halal certificate remains valid as long as there are no changes to raw materials, suppliers, or manufacturing processes.

5. Labeling Requirements for Soft Contact Lenses in Indonesia

In accordance with Minister of Health Regulation No. 62 of 2017 on Medical Device Advertising and Labeling, soft contact lenses must be labeled accurately, clearly, and without misleading information.

Label Placement

Labels must be affixed to:

• Primary packaging (blister or vial)
• Secondary packaging (box)

⚠️ Important note: Labels must not be attached directly to the lens. All required information must appear on the packaging.

Mandatory Label Information

• Product name
• Specifications (type, diameter, base curve, power)
• Name and address of manufacturer
• Name and address of distributor
• Kemenkes RI Medical Device License Number (AKL/AKD)
• Batch number and expiration date
• Halal logo (once certified)

Example NIE format:

KEMENKES RI AKL xxxxxxxxxxxxx

Example of Label Format

Example of a Kemenkes RI AKL Label
(Source: Hati-hati Softlens Abal Tanpa Nomor AKL! Berbahaya!  – X2 Softlens)

Halal Label

Once a product has obtained a Halal Certificate, the manufacturer or importer must display the official Halal Logo on the product packaging. The logo must not be altered in color, shape, or proportion, and it must be placed in a visible area on the primary or secondary label.

How INSIGHTOF Consulting Indonesia Can Help

INSIGHTOF Consulting Indonesia provides comprehensive regulatory assistance for medical devices in Indonesia, including:

• Medical Device Registration (for soft contanct lenses and related components) with the Ministry of Health (Kemenkes RI)
• Halal Certification Support for medical devices and related products

👉 Contact us today to ensure your products are legally registered and fully compliant with the latest Indonesian regulations.