The article outlines the key aspects to be covered by the labeling used for contact lenses.
Table of content
The Saudi Food and Drug Authority (SFDA), the country’s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to labeling information for contact lenses and solutions. The document provides an overview of the applicable regulatory requirements, as well as additional clarifications and recommendations to be taken into consideration by medical device manufacturers and other parties involved in order to ensure compliance.
At the same time, the authority reserves the right to make changes to the guidance and recommendations provided therein, should such changes be reasonably necessary to reflect corresponding amendments to the underlying legislation. In particular, the SFDA has issued this document to define and clarify the contents of labeling for contact lenses and their associated solutions.
The goal is to ensure that manufacturers and authorized representatives (ARs) who market these products within the Kingdom of Saudi Arabia (KSA) meet the required labeling standards. This document aligns with various legal and regulatory frameworks, including the “Medical Devices Law” and its implementing regulations, as well as the specific standards for contact lenses and their care products.
Purpose
The main objective of this document is to provide a clear understanding of the mandatory requirements for labeling contact lenses and their solutions in accordance with Saudi Arabian laws and regulations.
The labeling requirements are designed to safeguard consumers and healthcare professionals by providing essential information about the contact lenses and solutions, such as their intended use, type, and other critical details. As explained in the document, this information is vitally important for ensuring safe and effective usage.
Scope
This document applies to all manufacturers and ARs of contact lenses and their solutions who plan to make these products available within Saudi Arabia. The scope extends to various types of contact lenses, such as soft and hard lenses, as well as the solutions used for their care, including cleaning, disinfecting, and storing products.
Background
This document has been issued in reference to key legal frameworks, including:
- Article Seventeen of the “Medical Devices Law” (Royal Decree No. M/54 dated 6/7/1442 H),
- Article (10/28) of the “Implementing Regulation of Medical Devices Law” (Saudi Food and Drug Authority Board of Directors decree No. 3-29-1443 dated 19/2/1443H),
- The “Requirements for Medical Devices Marketing Authorization (MDS-REQ1)” guidelines,
- The Saudi standard “Ophthalmic optics — Contact lenses and contact lenses care products — Labeling (SFDA.MD/GSO ISO 11978:2019)”.
These regulations are in place to ensure that products being marketed within KSA adhere to the highest standards for safety, efficacy, and clarity of information.
Content of Labeling for Contact Lenses and Their Solutions
First of all, the document states that the labeling of contact lenses and their solutions must meet certain language specifications:
- English: All labeling must be provided in English.
- Arabic: When the product is intended for use by a layperson, the labeling must also be written in Arabic. This includes the complete and clear translation of Instructions for Use (IFUs) for both the contact lenses and their solutions. Additionally, the labels on both the solutions and the contact lenses themselves must be written in Arabic, at least providing information on the purpose, type, and schedule for wear and replacement frequency.
It is important to note that the translated labeling must be approved by the manufacturer and included in the technical documentation for the product.
The labeling of contact lenses and their solutions must include the following information to ensure proper usage and safety. This content should be clearly displayed on both the product label and its IFU.
In case of contact lenses, labeling should provide the following details:
- Purpose of Contact Lenses: The label should indicate whether the lenses are for vision correction, cosmetic purposes, or other uses.
- Type of Lenses: Indicate whether the lenses are soft or hard.
- Schedule for Wear: Specify the recommended duration of wear, such as weekly, monthly, or quarterly.
- Nature of Use: Indicate whether the lenses are intended for daily or extended wear, as applicable.
- Replacement Frequency: Clarify how often the lenses need to be replaced, such as daily disposable lenses.
- Material Properties: Provide information on the materials used in the contact lenses.
- Lens Parameters: Include details about the contact lenses’ parameters, such as power/sphere, base curve, and diameter, as well as cylinder and axis for astigmatism and additional spherical power for presbyopia if relevant.
- Custom-made Device: Indicate whether the lenses are custom-made, if applicable.
- Single-use Label: Indicate whether the lenses are single-use, if applicable.
- Product Name: Display the trade name or brand name in both English and Arabic, as it is pronounced in English.
- Model/ID of the Product: Include the model number or product ID.
- Manufacturer’s Name and Address: Display the name and address of the manufacturer.
- Traceability: Provide an indication of the traceability method for the product.
- Expiry Date: Indicate the product’s expiration date.
- Maximum Period of Use: Specify the maximum period of use after the container is first opened, if applicable.
- Cleaning Instructions: Include any instructions for cleaning the lenses, if applicable.
- Cautions and Warnings: Provide any necessary caution, precaution, or warning information, including contraindications.
- Consulting a Healthcare Professional: Advise users on when to consult with a healthcare professional, if applicable.
- Storage and Transportation: Include any special storage and transportation conditions for the product.
- Sterilization Method: Provide information on the sterilization method used for the lenses.
- Physical Appearance Details: Optionally, provide information about the physical appearance of the lenses.
- Machine-readable Forms: Indicate the presence of machine-readable forms such as RFID or barcodes.
In case of contact lens solutions, labeling should contain the following:
- Purpose of Solution: Specify the purpose of the solution, whether it is for rinsing, cleaning, disinfecting, storing, or as a multipurpose solution.
- Material Properties: Provide details on the material properties of the solution.
- Product Name: Display the trade name or brand name in both English and Arabic.
- Manufacturer’s Name and Address: Include the manufacturer’s name and address.
- Traceability: Provide the traceability method.
- Expiry Date: Indicate the expiration date.
- Period of Use After Opening: Specify the maximum period the solution can be used after the container is opened.
- Cleaning Instructions: Provide cleaning instructions if applicable.
- Cautions, Precautions, and Warnings: Include any warnings, cautions, and contraindications.
- Consulting a Healthcare Professional: Advise users on when to consult a healthcare professional if necessary.
- Storage and Transportation: Include any special storage and transportation conditions.
- Sterilization Method: Provide information on the sterilization method.
- Physical Appearance Details: Optionally, include information on the physical appearance of the solution.
- Machine-readable Forms: Indicate the presence of machine-readable forms such as RFID or barcodes.
Conclusion
In summary, the labeling requirements outlined by the SFDA ensure that contact lenses and their solutions are clearly identified and used safely by consumers. These requirements are vitally important for maintaining the safety, efficacy, and traceability of contact lenses and their care solutions in the KSA market.
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