The Ministry of Public Health of Thailand has released standards and specifications for Ophthalmic Viscosurgical Devices (OVD) to ensure that standards in Thailand are consistent with global medical device standards.
The Ministry of Public Health of Thailand recognizes the importance of ensuring that the standards and specifications of Ophthalmic Viscosurgical Devices (OVD) are consistent with global medical device standards. OVD are viscoelastic solutions used in eye surgery. They contain sodium hyaluronate, chondroitin sulfate or hydroxypropyl methylcellulose, and are used to maintain space to protect intra-ocular tissues and manipulate tissue during surgery; however, the products are removed before the surgical process is completed.
The main standards in Thailand for Ophthalmic Viscosurgical Devices are as follows:
- OVDs are only available for sale to licensed ophthalmologists in a hospital or clinic setting
- The OVD indication of use must meet international standards such as ISO 15798:2010 Ophthalmic Implants-Ophthalmic viscosurgical devices
- OVDs must be produced by a manufacturer that has acquired production quality system certification for such products according to international standards such as Good Manufacturing Practice (GMP) and ISO 13485