Malaysia MDA: Non-Corrective Contact Lens for Medical Devices

November 1, 2019

As of 1 January 2018, non-corrective contact lens will be regulated as medical devices by the Medical Device Authority (MDA). According to the Medical Device (Declaration) Order 2017, “non-corrective contact lens” is contact lens which is not used to correct, remedy or relieve any refractive abnormalities or optical defects of sight. Non-corrective contact lenses are used to change the look or colour of a user’s eyes.  Unlike corrective contact lenses, they do not correct vision. Non-corrective contact lenses may also be referred to as cosmetic, decorative, coloured or fashion contact lenses.

 

Non-corrective contact lenses, just like the corrective contact lenses can pose serious risks if they are obtained without a prescription or not used correctly. The risks include:

  1. Blindness

  2. A cut or scratch on the top layer of the eyeball (corneal abrasion)

  3. Allergic reactions like itchy, watery red eyes

  4. Decreased vision

  5. Infection

All types of contact lenses have associated risks. Therefore, MDA shall regulate non-corrective contact lenses as medical devices. Establishments shall follow the requirements as stated below.

 

Requirements for Establishments

Manufacturers of non-corrective contact lenses shall get ISO 13485 certification.

According to the Medical Device Regulations 2012, non-corrective contact lenses shall be considered as Class B or C medical devices depending on the duration of use.

In order to place in the market, manufacturers and authorised representative shall apply for establishment license and register the non-corrective contact lenses. The application shall be made by the establishment to MDA through the MeDC@St system.

 

Click here to see the guidelines on how to apply for the establishment license and medical device registration.

 

Compliance and Enforcement

According to Section 5 of the Medical Device Act 2012 (Act 737):

No medical devices shall be imported, exported or placed in the market unless the medical device is registered under this Act.

Any person who contravenes subsection (1) commits an offence and shall, on conviction, be liable to a fine not exceeding two hundred thousand ringgit or to imprisonment for a term not exceeding three years or to both.

 

User Awareness

Do not buy or use unregistered non-corrective contact lenses.

For further information, users are encouraged to abide by the direction from Malaysian Optical Council.

 

Click here to download the brochure.

 

Reference:
Food and Drug Administration, MyHEALTH, Canadian Ophthalmology Society, Government of Canada, Medical Device Act 2012 (Act 737), Medical Device (Declaration) Order 2017

 

Contact us at info@arqon.com.

 

Please reload

Recent Posts
Please reload

Categories
  • LinkedIn - White Circle
  • YouTube - White Circle
  • Twitter - White Circle

© 2018 ARQon All Rights Reserved. 

  • LinkedIn - White Circle
  • YouTube - White Circle
  • Twitter - White Circle