Notice

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Contact Device Licensing

November 23, 2005

Our file number: 05-126068-594

To: All manufacturers, dispensers and retailers of contact lenses

Subject: Contact lenses are not considered to be custom-made medical devices

APPLICATION

This notice affects:

• manufacturers who sell contact lenses to retailers;
• optical laboratories or retailers who alter finished lenses to account for a patient's specific requirements; and
• optical laboratories or retailers who use lens buttons (blanks) to make contact lenses.

DEFINITIONS

As defined in the Medical Devices Regulations:

"manufacturer" means a person who sells a medical device under their own name, or under a trade-mark, design, trade name or other name or mark owned or controlled by the person, and who is responsible for designing, manufacturing, assembling, processing, labelling, packaging, refurbishing or modifying the device, or for assigning to it a purpose, whether those tasks are performed by that person or on their behalf.

"custom-made devices" means a medical device, other than a mass-produced medical device, that

1. is manufactured in accordance with a health care professional's written direction giving its design characteristics;

2. differs from medical devices generally available for sale or from a dispenser; and

3. is

   1. for the sole use of a particular patient of that professional, or
   2. for use by that professional to meet special needs arising in the course of his or her practice.

CONTEXT

Finished contact lenses require class II medical device licences. It has always been Health Canada's position that contact lenses that are altered in optical laboratories based on prescriptions, and sold to specific patients by optical retailers are class II medical devices requiring medical device licences. To date, Health Canada has not received any medical device licence applications, and therefore has not issued any licences, for this type of contact lens.

Prescription contact lenses sold to patients by retailers, do not fit the custom-made device definition as set out in the Medical Devices Regulations. In order to be considered a custom-made device, a device must meet all three conditions laid out in the definition. Although prescription contact lenses do meet condition (a), they do not meet conditions (b) and (c). The adaption based on the prescription would not be of a nature that the lens could be used exclusively by a single patient. Therefore, contact lenses pursuant to a prescription do require medical device licences.

LICENSING INFORMATION

Finished lenses can be sold by a manufacturer to a retailer, and then by the retailer directly to the client. When the lens is not altered in any way, and the lenses are packaged and labelled with the manufacturer's name, the manufacturer is required to obtain a class II medical device licence in accordance with section 26 of the Medical Devices Regulations. This is consistent with the current practice.

It is also possible for a retailer to use finished lenses to fill a prescription. In this case, the finished lenses would have the appropriate dioptres for vision correction, and may be fashioned by an optical laboratory to account for a patient's astigmatism. The processes undertaken by the optical laboratory are considered to be performed on behalf of the manufacturer. This is comparable to a subcontracted process step within a complete manufacturing process. In this case, the manufacturer of the original finished lens will require a class II medical device licence.

Sometimes optical laboratories may chose to use lens buttons (blanks) to make their lenses. Lens buttons themselves are not considered to be medical devices, and therefore do not require medical device licences. Under these circumstances, the laboratory is responsible for adding the proper dioptres, shaping the lenses as required, etc. Assuming that the laboratory then sells the lenses under their own name, they are considered to be the manufacturer, and require a class II medical device licence for the finished lens.

ADDITIONAL INFORMATION

For additional information on device licensing, please contact the following:

Device Licensing
Medical Devices Bureau
Therapeutic Products Directorate
Room 1605, Statistics Canada Main Building
Tunney's Pasture, Address Locator 0301H1
Ottawa, Ontario
K1A 0K9

Phone: (613) 957-7285
Fax: (613) 957-6345
E-mail: device_licensing@hc-sc.gc.ca