The Thai FDA has issued a clarification and reminder that all types of contact lenses whether used for medical or aesthetic purposes are classified as medical devices in Thailand. This announcement aims to promote consumer safety by preventing improper use, ensuring that only high quality and compliant products reach customers, and reinforcing proper regulation in accordance with existing medical device laws.
To read the full announcement: https://www.facebook.com/fdathaidevice/?locale=th_TH
Key Legal Definitions and Classification
Contact Lens
Contact Lens: A product made from polymer or other materials, shaped like a lens that covers the cornea. It is intended to be used for correcting vision abnormalities, treating eye diseases, aesthetic purposes, and other specific purposes.
For example:
- Corrective lens
- Therapeutic Lens
- Cosmetics/Colored Lens
Medical Device Classification
Medical Device Classification: Contact lenses fall under the definition of a medical device as per Section 4 (3) of the Medical Device Act.
Regulatory Compliance
Manufacturers and importers of contact lenses are required to obtain a Notification certificate from the Thai FDA prior to marketing and distributing these products. Product Labelling and instruction for use (IFU) of contact lenses must comply with the requirements issued by the Ministry of Public Health.
Recommendations for Users
- Always undergo an eye examination before using contact lenses.
- Check the product packaging for a valid TFDA registration number to ensure it is an approved medical device.
- Follow strictly the recommended re usage period, cleaning and replacement schedule as indicated on the label or instruction for use (IFU).
Precautions
- Do Not share contact lens with others.
- Do not wear contact lenses beyond the specified usage period.
- Never sleep while wearing any type of contact lens.
- Do not use contact lenses from packaing that is is damaged, tampered with, or previously opened. .
- Avoid wearing contact lenses while swimming
Reference
Reference: Ministry of Public Health Announcement on Contact Lenses, published in the Royal Gazette, Special Edition 127, Part 120, on October 14, 2010.
Implications to Clients
All types of contact lens are considered as medical device and therefore require Thai FDA approval prior importation and sale in Thailand. Additionally, manufacturers and importers of contact lens must comply with all applicable regulatory requirements, including product notification, labeling compliance, and quality standards.
Effective Date
Effectivity Date: Immediately
For inquiries or support regarding medical device regulatory requirements in Thailand, please contact sales@andamanmed.com.
