November 13, 2017
On 13 November 2017, Medical Device Authority (MDA) released the Medical Device (Declaration) Order 2017, which comes into operation on 1st of January, 2018. In this order, the MDA declares “Non-Corrective Contact Lenses”, also commercially known as “Cosmetic Contact Lenses”, as legitimate medical device. “Non-Corrective Contact Lens” means a contact lens which is not used to correct, remedy, relieve any refractive abnormalities or optical defects of sight.
Thus, declaration of this new Order indicates two important things to take note of, as below:
1) An establishment who has imported, exported or places in the market a non-corrective contact lens before the date of coming into operation of this Order, a.k.a. 1st of January, 2018, shall within six months from 1st of January, 2018, apply for the registration of the non-corrective contact lens under section 6 of the Medical Device Act 2012 and apply for an establishment licence under section 16 of the Act.
2) An establishment who makes an application for registration of non-corrective contact lenses and for an establishment licence, as stated in subparagraph (1) above, may continue to import, export, or place in the market a non-corrective contact lens whilst pending determination of the application.
Based on this Order, any establishment that is currently (or in the future) involved in the import, export and marketing of non-corrective contact lens must start applying for the registration of this medical device and the establishment licence before 1st of June, 2018.
For more information, check out the Medical Device (Declaration) Order 2017 on MDA’s official website.