What New Medical Device Rules Mean for Students in Pharmaceutical Regulatory Affairs

regulatory affairs courses

A medical device is defined by Health Canada as:

  • an instrument, apparatus, or other similar article
  • diagnoses, treats, mitigates, or prevents conditions and diseases in human beings, prevents conception, cares for humans at or after birth, diagnoses pregnancy or restores, modifies, or corrects body structure

Some examples of medical devices include pacemakers, cardiovascular stents, respiratory ventilators, or even small items like tongue depressors or bandages.

With new regulations coming into play later in 2019, read on for how this could affect regulatory affairs!

Pacemakers are an example of medical devices and fall under these regulations

Pacemakers are an example of medical devices and fall under these regulations

What Are some Medical Device Safety Issues?

Unfortunately some medical device issues can arise, which has led to a revision of the rules in Canada surrounding incidents. Though many patients do not experience these issues, some examples of medical device problems include:

  • Metal debris from implants, which could lead to a reaction in the tissues around the joint
  • Issues with pacemakers, providing unnecessary therapy or failing to provide it when needed
  • Re-narrowing of the arteries or clotting of blood after insertion of cardiovascular stents
  • Atrophy of the diaphragm or oxygen toxicity due to respiratory ventilators

What Do these New Regulations Change or Entail?

In June 2019, Health Canada introduced new regulations that will come into play starting December 16th. This means that students currently in or graduating from regulatory affairs programs will be entering the field with these rules in effect very soon. The revisions require hospitals in Canada to report incidents involving medical devices within 30 days of their occurrence. It also requires manufacturers to report adverse events in annual summaries and notify Health Canada in the event that there are changes to the benefits and risks of a device.

New regulations will require hospitals to report incidents with medical devices within 30 days

New regulations will require hospitals to report incidents with medical devices within 30 days

These revisions build on the Action Plan on Medical Devices and the Protecting Canadians from Unsafe Drugs Act, following an investigation by the International Consortium of Investigative Journalists into harm caused to patients and users linked to medical devices that were surgically implanted.

Which Medical Devices Are Affected?

The new rules will affect devices marketed as Class II, III, and IV. The Government of Canada has medical device regulations that specify how they are categorized. These classifications are similar to those in the USA and EU, but still have differences. Classifications are used to determine the level of risk associated with various devices. Pharmaceutical regulatory affairs deals with all classifications of medical devices, with different risks related to each category.

Some of these specifications include:

Class II:

  • Denture materials and orthodontic appliances and their accessories
  • Non-invasive devices coming into contact with injured skin
  • Devices using radiography

Class III:

  • Devices intended to remain in the body or on the surface of the eye for at least 30 days
  • Invasive devices intended to be absorbed by the body
  • Devices for mammographies

Class IV:

  • Devices that may introduce a foreign substance into the body that is potentially hazardous
  • Devices that control a patient’s treatment through a close loop system (sensing, interpreting and treating a condition without human intervention)
Dentures are Class II medical devices

Dentures are Class II medical devices

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