Ophthalmic Medical Devices | 合法醫療器材資訊網

An ophthalmic medical device can be defined as a device that fulfils a medical purpose for use in optometry and ophthalmology. These devices range from non-invasive devices and instruments often used for diagnoses, to invasive devices, such as contact lenses (and their associated care products), and implantable devices, such as intraocular lenses and glaucoma stents. Surgical systems, including lasers and phacoemulsification machines, and surgical instruments are also examples of these devices.

We collaborate with our in-house clinicians and, where products require additional expertise,  we consultant our other technical teams covering all areas from active and active implantable, to medicinal substances, devices utilizing animal tissue and sterile medical devices.

BSI is able to offer CE certification services under the EU MDR and UKCA services under the UK MDR 2002 for ophthalmic med...