In accordance with “Medical Device” definition (3) in Section 4, Section 5. Paragraph 1, Section 6 (2) (4) (5) and (13) Section 44 and Section 45 of Medical Device Act BE 2551 (2008) as follow:
- In this announcement “Contact Lens Care Products” means products that are specifically intended for cleaning, washing, disinfecting or moisturizing the contact lens. Or relieving eye discomfort from wearing contact lens as follows:
1.1 Saline solutions mean products that contain components of sodium chloride as the main active ingredient Concentration of 0.6 percent with weight and water soluble, which may be in solution form Sterile salt tablets or capsules of salt that must be mixed with distilled water before use for cleaning and remove particle stains after wearing contact lens.
1.2 Daily cleaners mean products intended to remove particle stains from contact lens. This may be a component of the contact lens sterilization system or multi-purpose solutions.
1.3 Periodic cleaners mean products intended to remove and eliminated stains that is on contact lens such as protein that cannot be removed by using contact lens daily clean products.
1.4 Chemical disinfecting solution means products that contain preservatives or antimicrobial agents aiming to abolishes the infection on the contact lens when using contact lens for a specified period.
1.5 Chemical disinfection system) means products that contain over 2 contact lens care products. Intended to use together to clean any disinfection on contact lens employing chemical methods which includes cleaning, washing and soaking the contact lens.
1.6 Hydrogen peroxide system mean products that contain over 2 contact lens care products, such as hydrogen peroxide drugs, substances that neutralize and lens vial for contact lens storage. It is intended to work together to kill bacteria on contact lens with hydrogen peroxide.
1.7 Conditioning solution means solution that consists of several main active ingredients such as preservatives and moisturizing substances (ophthalmic demulcents) intended to increase water content of qualified Hydrophobic contact lens such as RGP and PMMA before the wearing of contacting lens, removed and eliminated stains that is on contact lens after soaking for a required period.
1.8 Multi-purpose solutions mean product in the form of a solution consisting of several main active ingredients intended for cleaning disinfected contact lens on contact lens via chemical methods, clean and retain contact lens.
1.9 in - eye contact lens solutions: lubricating and / or rewetting drops) means products that are intended for eye drops while wearing contact lens to relieve eye discomfort from wearing contact lens by mechanism action that do not be caused any pharmacological processes or may be used to lubricate the contact lens or wet before wearing.
1.10 Heat disinfecting units means products intended to disinfect hydrophilic properties contact lens (soft contact lens) with heat.
1.11 Contact lens accessories) means tools or equipment intended to use with contact lens care products to help clean contact lenses, such as tools or devices that have mechanical cleaning aid and accessory cleaning pads.
2. Contact lens care products are classified as Notified Medical Device.
3. Contact lens care products must be in accordance to the standard of International Organization Standards for Standards 14534 (ISO 14534: 2011 Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements) or the update issue or other equivalent standards or as approved by the Minister.
4. Contact lens care products must be manufactured by a certified system manufacturer in accordance to National standards or International standards such as criteria and methods for good production of medical device (GMP), International organization standards regarding the standard (ISO 13485) (ISO 13485: 2003 or ISO 13485: 2016) Or the update issue.
5. Manufacturer or importer must prepare product labelling in Thai is sufficient, while other languages are optional.
6. Manufacturer or importer must prepare medical device description in Thai.
7. In the case of importing contact lens care products, the importers must prepare the packaging labelling and medical device description in accordance to clause 5,6 before selling, within thirty days from the date that medical device has checked for release.
8. Registration of the drug certificate holder, contact lens care products before the effective date of this notification and wishes to continue operating, must apply for establishment import license along with preparing the registration of medical device to be notified within the period of 30 days from the effective date of this notification.
9. Manufacturer or importer who wishes to continue operating and had retrieved license before the implementation of this announcement must apply for establishment import license along with preparing the registration of medical device to be notified within the period of 30 days from the effective date of this notification.
10. This announcement shall come into force after 180 days from the date following the date of its publication in Government Gazette onwards.
Translated from official ThaiFDA announcement, by:
References:
Ministry of Public Health Announcement regarding Contact Lens Care Products