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December 2018

Regulatory update:

Health Canada’s Action Plan on Medical Devices: Continuously Improving Safety, Effectiveness and Quality

The action plan is comprised of 3 parts:

  • Part I: Improve how devices get on the market
  • Part II: Strengthen monitoring and follow-up
  • Part III: Provide more information to Canadians

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October 2018

Health Canada has published a new and final Guidance Document 

Regulatory update:

This guidance document provides information on applications for Investigational Testing Authorization (ITA). This includes:

  • ITA review process
  • post-authorization requirements
  • application format and required documents
  • roles and responsibilities of manufacturers, importers and Health Canada

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September 2018

Regulatory update:

Health Canada is launching a new pilot project:

“Device Advice: Pre-Clinical Meetings”, enabling Medical Devices manufacturers to receive regulatory advice and recommendations on their Clinical Trials protocols. 

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August 2018

Regulatory update:

Health Canada is adopting the use of ToC format for Medical Devices Licence Applications

The International Medical Device Regulators Forum (IMDRF) has identified the need to harmonize the documentation of evidence to support medical device market authorization requests. Health Canada intends to adopt the ToC formats to encourage and support the global convergence of documentation requirements for medical devices. As of April 1, 2019, manufacturers will be expected to submit premarket applications for Class III & Class IV medical devices in either the ToC or Health Canada formats. The Summary Technical Documentation (STED) format will be discontinued.

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July 2018

Regulatory update:

Health Canada is proposing “Pause the Clock” for Pre-market Submissions/Applications

Health Canada clock-stop proposal in the device and drug pre-market review process, is intended to allow more time for clarification of specific issues

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May 2018

Regulatory update:

Health Canada announced Medical Device Single Audit Program (MDSAP) Reduction of Audit Times for Small-sized Enterprises – update

Health Canada announced that it has identified additional opportunities for audit duration reductions in collaboration with the MDSAP Consortium (Canada, USA, Japan, Brazil and Australia). As a result, manufacturers could benefit from additional reductions in audit duration if they meet the certain criteria.

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April 2018

Regulatory update:

Health Canada announced Adjustments to Medical Device Single Audit Program (MDSAP) Transition

Health Canada has been actively engaging with the medical device industry to support its transition to the new MDSAP program by January 1st, 2019. In light of the comments received, the Department announced modifications to the transition process that will make it easier for manufacturers to transition to MDSAP.

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January 2018

Regulatory update:

FDA announces new steps to facilitate efficient generic drug review to enhance competition, promote access and lower drug prices

The FDA Drug Competition Action Plan has three main components: reducing gaming by branded companies that can delay generic drug entry; resolving scientific and regulatory obstacles that can make it difficult to win approval of generic versions of certain complex drugs; and improving the efficiency and predictability of the FDA’s generic review process to reduce the time it takes to get a new generic drug approved and lessen the number of review cycles undergone by generic applications before they can be approved. The FDA is releasing two documents that will streamline and improve aspects of the submission and review of generic drug applications (ANDA)

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November 2017

Regulatory update:

FDA announces comprehensive regenerative medicine policy framework

The framework is designed for the development and oversight of regenerative medicine products, including novel cellular therapies. It is outlined in a suite of four guidance documents – builds upon the FDA’s existing risk-based regulatory approach to more clearly describe what products are regulated as drugs, devices, and/or biological products. Further, two of the guidance documents propose an efficient, science-based process for helping to ensure the safety and effectiveness of these therapies, while supporting development in this area.

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October 2017

Regulatory update:

FDA to recognize GMP inspections by 8 EU drug regulators

The eight regulatory authorities found to be capable are those located in: Austria, Croatia, France, Italy, Malta, Spain, Sweden and the United Kingdom. This achievement marks an important milestone to successful implementation and operationalization of the amended Pharmaceutical Annex to the 1998 U.S.-European Union (EU) Mutual Recognition Agreement (MRA) that enables U.S. and EU regulators to utilize each other’s good manufacturing practice inspections of pharmaceutical manufacturing facilities.

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September 2017

Regulatory update:

FDA releases draft guidance on microneedling devices

The US FDA has issued a draft guidance detailing when it considers “microneedling” products to be medical devices and subject to regulation. In recent years microneedling has emerged as a trendy cosmetic procedure often advertised as a minimally invasive option for treating scars, wrinkles, acne and stretch marks, and is often performed at home or at plastic surgery centers. In its draft guidance, FDA says that many microneedling products meet the definition of a medical device and must be submitted to the agency for review. 

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June 2017

Regulatory update:

FDA: Interchangeable Biosimilar Approvals Expected Within 2 Years

According to the Biologics Price Competition and Innovation Act, which established the pathway by which biosimilars can be approved by FDA, an interchangeable biosimilar is biosimilar to its reference product and “can be expected to produce the same clinical result as the reference product in any given patient.” Unlike in the EU, which does not have interchangeable biosimilars, in the US they can be substituted for their reference products without a doctor specifically calling for substitutions.

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May 2017

Regulatory update:

EU tighten medical device regulations

The clock started ticking today on tighter new regulations for the medical device and in vitro diagnostic industries in Europe when the European Commission published the new rules. The regulations, approved last month by the European Parliament, include stronger post-market surveillance rules and adding a safety check for high-risk devices. The new EU rules, which also mandate a unique identification system and implant cards for patients, are slated to go into effect 3 years from today for medical devices and 5 years for IVD products.

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April 2017

Regulatory update:

FDA has exempted almost all class I devices from the premarket notification (510k) requirement

FDA has published a list of 510(k) exempt and Good Manufacturing Practice (GMP)/Quality System exemptions listed by device class. If a manufacturer’s device falls into a generic category of exempted class I devices as defined in 21 CFR Parts 862-892, a premarket notification application and FDA clearance is not required before marketing the device in the U.S. However, these manufacturers are required to register their establishment and list the generic category or classification name.

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Regulatory update:

Health Canada changes to the Natural Health Products Directorate (NHPD)

The Natural Health Products Directorate (NHPD) has changed its name to the Natural and Non-prescription Health Products Directorate (NNHPD) subsequent to its recently expanded mandate to include the oversight of non-prescription and disinfectant drugs in addition to natural health products (NHPs). Health Canada is currently modifying documents to reflect this change.

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March 2017

Regulatory update:

European and US regulators agree on mutual recognition of GMP inspections of medicines manufacturers

The United States and the European Union (EU) completed an exchange of letters to amend the Pharmaceutical Annex to the 1998 U.S.-EU Mutual Recognition Agreement. Under this agreement, U.S. and EU regulators will be able to utilize each other’s good manufacturing practice inspections of pharmaceutical manufacturing facilities. Mutual Recognition promises new framework for pharmaceutical inspections for United States and European Union. 

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February 2017

Regulatory update:

Health Canada Regulatory Transparency and Openness Framework

Health Canada has launched the Regulatory Transparency and Openness Framework, to support the Government of Canada’s Open Government initiative. As a regulator, Health Canada plays an important role in protecting the health and safety of Canadians and is committed to greater transparency and openness to further strengthen trust in their regulatory decisions.

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