I want to sell contact lenses (biological safety)

Updated: July 2024, 3

In today's busy lifestyle, contact lenses have become more common than glasses.
Especially with changes in lifestyle, it has also become a great choice for sports and outdoor activities.

What do you need to sell contact lenses?

There are various types of contact lenses, but one of the most commonly used ones is reusable lenses for vision correction.
　
The general definition is as follows.
　

In order to sell lenses, you must first obtain a "Class 1 Medical Device Manufacturing and Sales License" and receive "Medical Device Manufacturing and Sales Approval" for the above products. Additionally, if you wish to sell to general consumers as a BtoC, you will need to obtain a "Highly Controlled Medical Device Sales License."
　
For information on Type 1 Medical Device Manufacturing and Sales Business/Highly Controlled Medical Device Sales Business License, please refer to ~, and in this blog, we would like to know what is required for approval.
　
First, if we want to introduce contact lenses to the world as medical devices, we need to ensure their safety and effectiveness. In that case, it is necessary to create and test products according to the following standards.
　

• JIS B 7183, Lensmeter
• JIS K 7361-1, Plastics - Test method for total light transmittance of transparent materials - Part 1: Single beam method
• JIS K 7127, Plastics - Test methods for tensile properties - Part 3: Test conditions for films and sheets
• JIS K 7161-1, Plastics - How to determine tensile properties - Part 1: General rules
• JIS K 7142, Plastics - How to determine refractive index
• JIS K 7209, Plastics - How to determine water absorption rate
• JIS T 0993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing in the risk management process
• JIS Z 8722, Color measurement methods - Reflected and transmitted object colors
• ISO 9394, Ophthalmic optics－Contact lenses and contact lens care products－Determination of biocompatibility by ocular study with rabbit eyes
• ISO 11987, Ophthalmic optics－Contact lenses－Determination of shelf-life
• ISO 18369-3, Ophthalmic optics－Contact lenses－Part 3: Measurement methods
• ISO 18369-4, Ophthalmic optics - Contact lenses - Part 4: Physicochemical properties of contact lens materials
• Handling of documents to be attached when applying for manufacturing (import) approval of soft contact lenses and disinfectants for soft contact lenses (Pharmaceutical Review No. 11, March 3, 31) (hereinafter referred to as "handling of documents")
• : Regarding the basic concept of biological safety evaluation necessary for application for manufacturing and marketing approval of medical devices (No. 24 No. 3 issued by Yakuhinki, March 1, 0301) (hereinafter referred to as “Basic concept of biological safety evaluation”) (Basic idea)

　
Among the above, the following are particularly required:ISO 18369-3as well as the ISO 18369-4.
According to this standard, we judge whether a lens can function as a contact lens in various aspects such as apical refractive index, luminous transmittance, oxygen permeability coefficient, and strength. Additionally, if it is a medical device that comes into contact with the skin or mucous membranes, it must be proven that it meets not only the above standards but also biological requirements.

What are biological safety standards?

Biological safety evaluation of medical devices is, in principle, performed in accordance with JIS T 0993-1 or the international standard ISO 10993 "Biological evaluation of medical devices" series.
　
So why should we evaluate biological safety?
　
It is necessary to clarify the intended use or purpose of a medical device and its safety characteristics, assess the risk of biological adverse effects (toxic hazards), and estimate that risk to ensure safety as a medical device. This is to ensure that.

“Hazard” and “Risk” in biological safety

●hazard: Factors such as genotoxicity, sensitization, and chronic systemic toxicity that may cause adverse effects on human health.

●risk　: The probability of occurrence of adverse effects on human health caused by the hazard and the extent of the effects.

　
Although safety is evaluated in one word, the evaluation criteria differ depending on which part of the human body the product comes into contact with and for how long. The criteria can be divided into the following:
　

• Classification by contact area Non-contact
• Body surface contact: skin, mucous membranes, damaged surfaces
• Connecting the inside and outside of the body: indirect blood flow path, tissue/bone/dentin, circulating blood
• In-body implantation: tissue/bone, blood
• Classification by duration of contact Temporary contact: Used once or multiple times, and the cumulative contact period is less than 24 hours
• Short-term/medium-term contact: Used once or multiple times, and the cumulative duration of exposure is between 24 hours and 30 days.
• Prolonged contact: Used once or multiple times, and the cumulative contact period exceeds 30 days

　
The factors to be evaluated will change depending on the above standards, but for this contact lens, it is necessary to conduct cytotoxicity tests, skin sensitization tests, genotoxicity tests, subacute toxicity tests, etc. according to ISO10993-1. .