1. Eyeglasses as Medical Devices
Although eyeglasses are often seen as fashion accessories or daily necessities, they are actually classified as medical devices in Indonesia. This is because their primary function is directly related to vision correction — whether for nearsightedness (minus), farsightedness (plus), or astigmatism (cylinder).
According to the Ministry of Health of the Republic of Indonesia (Kemenkes RI), eyeglasses fall under the category of non-electromedical medical devices with low risk (Class 1A). This means they must comply with medical device quality standards and can only be distributed after obtaining an official Distribution License Number (NIE) from Kemenkes.
- Eyeglass lenses
- Category: Vision Care Equipment
- Subcategory: Optical Correction Devices
- Risk Class: Class 1A (low risk)
- Classification: Non-electromedical, non-sterile medical device
2. Which Part Needs to Be Registered: Lenses or Frames?
A common question arises:
“Do we need to register the lenses or the frames?”
- Lenses are the main components categorized as medical devices because they directly function to correct vision.
- Frames, on the other hand, are not considered medical devices unless they have an additional medical function (for example, a frame equipped with sensors, measuring tools, or other health-related technology).
Therefore, only the lenses must be registered with Kemenkes, not the frames.
For example, lenses from brands such as Essilor, Hoya, or Zeiss are categorized as Class 1A medical devices in Indonesia. Any manufacturer or importer wishing to distribute these products must obtain a Distribution License Number (NIE) from Kemenkes RI before selling them on the market.
3. Medical Device Registration Process in Indonesia
The registration process for medical devices, including eyeglass lenses, is carried out through the official online system called Regalkes (Registrasi Alat Kesehatan & PKRT Online).
The main steps include:
- Determining the Device Classification – Identifying the risk class (eyeglass lenses are classified as Class 1A).
- Fulfilling Technical Documentation Requirements – Including product data, quality testing, ISO 13485 certification from the manufacturer, and proof of quality compliance.
- Submission via Regalkes (Online) – Uploading documents and completing the PNBP (non-tax state revenue) payment.
- Evaluation and Approval – The Ministry of Health reviews the documents, and once approved, issues the Distribution License Number (NIE) allowing the product to be legally marketed in Indonesia.
4. Halal Certification Requirement for Class 1A Medical Devices
Under Law No. 33 of 2014 on Halal Product Assurance and Government Regulation No. 39 of 2021, all Class 1A medical devices, including eyeglass lenses, are now required to have Halal certification.
This regulation ensures that all materials, production processes, and packaging are free from non-halal substances — especially important for products that come into direct contact with the human body.
| Medical Device Class | Mandatory Halal Certification Deadline |
|---|---|
| Class A (low risk) | October 17, 2026 |
| Class B (medium risk) | October 17, 2029 |
| Class C (high risk) | October 17, 2034 |
| Class D (very high risk) | October 17, 2039 |
5. Halal Certification Process for Eyeglass Lenses
The Halal Product Assurance Agency (Badan Penyelenggara Jaminan Produk Halal – BPJPH), under the Ministry of Religious Affairs of the Republic of Indonesia, is the competent authority responsible for administering halal certification in accordance with Law No. 33 of 2014 on Halal Product Assurance and its implementing regulations. The assessment process is carried out in cooperation with accredited Halal Inspection Bodies (Lembaga Pemeriksa Halal – LPH).
- Raw Material Assessment
The inspection covers all materials used in the lenses, including polymers, coatings, and additives such as colorants or anti-reflective agents. Each material must be traceable to a halal source and free from substances derived from animals not slaughtered according to Islamic law or other non-halal origins. - Production Process Evaluation
The manufacturing process is reviewed to ensure there is no contamination with non-halal materials. This includes examining storage, cleaning, and handling procedures to maintain purity throughout the production chain. - Facility Inspection
The production facilities must implement and maintain a Halal Assurance System (SJPH), which includes internal control mechanisms, documented procedures, and staff training to consistently uphold halal integrity. - Halal Audit and Certification
An accredited LPH conducts an on-site audit and laboratory analysis if necessary. Once all requirements are met, BPJPH issues a Halal Certificate that is permanently valid, provided there are no changes to raw materials, suppliers, or manufacturing processes. - Renewal and Monitoring
Before the certificate expires, the manufacturer must apply for renewal and undergo re-evaluation. BPJPH and LPH may also conduct random inspections to ensure continuous compliance.
6. Product Labeling Requirements for Eyeglass Lenses
Labeling plays a crucial role in medical device distribution. Based on Minister of Health Regulation No. 62 of 2017 concerning Advertising and Labeling of Medical Devices, product labels must provide accurate, clear, and non-misleading information for both consumers and distributors.
Label Placement
Because eyeglass lenses are usually packed individually, labels should be affixed to:
- Outer packaging (box or sachet) containing one or more pairs of lenses.
- Secondary packaging, in cases where the product is imported in bulk.
⚠️ Important note: Labels must not be attached directly to the lens surface, as this can affect optical clarity. If product marking is necessary, use a removable transparent protective sticker instead.
Example of Label Format
Product Name: INSIGHT Clear Lens
Manufacturer: ABC Manufacturer, Korea
Distributor: PT Optik Indonesia, Jakarta
KEMENKES RI : AKL 1234567890123
Example of a Kemenkes RI AKL Label
(Source: https://shopee.co.id/kacamataminusnet)
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 eyeglass 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.
Do you need assistance registering your product in Indonesia?
Contact us today to start your registration process.
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