Notice - Application Requirements for non-in vitro diagnostic (IVD) Medical Devices Containing Drugs (Combination Products) - ON HOLD

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Contact: Device Licensing

August 31, 2009
Our file number: 09-122066-195

Notice

To: All manufacturers of licensed Class II, III and IV Medical Devices

Application

This notice affects:

1. all manufacturers of Class II, III and IV Medical Devices containing drugs.

Context

In 2008 the Health Canada Medical Devices Bureau introduced new licence application forms for Class II, III and IV medical devices. Section 10.1 Non-IVD Devices Containing Drugs of the new application forms states:

If the device contains a drug and is not an IVD, indicate the Drug Identification Number (DIN) or the Natural Product Number (NPN) and complete the information listed below. If the drug does not have a DIN or NPN, please provide the Drug Establishment Licence (DEL) number of the company from where the drug is sourced.

(Where "drug" includes a pharmaceutical or biological drug, or a natural health product.)

It has been brought to the attention of the Medical Devices Bureau that device manufacturers may face significant challenges in providing a DIN/NPN or DEL as required on the new licence application forms.

The Medical Devices Bureau is analyzing the scope of affected devices and drugs/natural health products in order to identify additional options besides DIN, NPN or DEL, which may be acceptable for certain medical device/drug combinations.

In the interim, the Medical Devices Bureau will continue to accept an attestation in Section 10.1 of the new application forms that drugs that are used in combination with medical devices, and for which a DIN or NPN has not been issued, are being manufactured in accordance with United States Pharmacopeia or Good Manufacturing Practices requirements.

Upon final clarification by Health Canada regarding Medical Device application requirements for device/drug and device/natural health product combination products, Medical Device Manufacturer's will be notified of any new requirements and given an appropriate transition period to meet them.

Additional Information

For additional information on Medical Device Licence Application Requirements, please contact the following:

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

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