Categories
Blog

MDSAP: What Is It and How Does It Apply to my Medical Device?

Who Needs an MDSAP Certificate?

Anyone looking to manufacture a Class II, III or IV medical device in Canada requires a Medical Device Licence (MDL) for each product they sell. In order to obtain an MDL you need an ISO 13485 certificate that has been issued through the Medical Device Single Audit Program (MDSAP). These certificates are evidence that your company has an appropriate quality management system in place to ensure that only safe and effective medical devices are made available for sale.

How do I obtain an MDSAP certificate?

First you must implement a quality management system within your company that meets the requirements of ISO 13485. The areas covered by these practices include design and development, production, storage and distribution, installation, and servicing of medical devices. Once all applicable procedures are in place you must contact an auditor that has been authorized to issue MDSAP certificates. Only certificates issued by approved auditors will be recognized by Health Canada.

Note that these certificates include a scope of the types of products that your company is authorized to manufacture. For example, if you obtain an MDSAP certificate for the manufacture of medical gloves you can get an MDL for medical gloves but not for home pregnancy tests. The scope of the certificate must match the type of product being sold. If you need to expand the scope of your certificate you must contact your auditor.

Why is it called a single audit program?

Historically every country would require their own audit of medical device manufacturer’s quality management system. This led to a situation where a company looking to sell in 5 different countries would often require 5 different audits of the quality management system. In order to reduce the burdens associated with multiple audits, several countries banded together to form the Medical Device Single Audit Program. Certificates issued through MDSAP will satisfy the audit requirements for all participating countries.

Countries that currently recognize MDSAP certificates include:

  • Australia
  • Brazil
  • Canada
  • Japan
  • USA

Are there any exemptions? What if I have an ISO 13485 certificate but it’s not MDSAP?

Health Canada won’t accept any other ISO 13485 certificate even if it’s from a major market such as the European Union. The only exception that has ever been granted is for devices related to the COVID-19 pandemic. Health Canada created a special approval pathway for these devices that would allow non-MDSAP certified companies to obtain authorization to sell their products.

I don’t have an MDSAP certificate and I’m not interested in obtaining one. What are my options?

The only option in this case is to enter into a private label agreement with a company that has one. The company you partner with must already have an MDSAP certificate and an MDL for the product they will be making. You will need to submit a Private Label Licence Application to Health Canada that states that your business partner will be conducting all manufacturing work and the product is identical to the already licenced product in every way except brand name and the company name listed on the label.

How Quality Smart Solutions can help:

Quality Smart Solutions offers many avenues of support including full support for obtaining any Medical Device License. Our team is equipped with professionals who have extensive experience in the Cannabis, Pharmaceutical, Natural Health Product, Food and Medical Device industries.

30 Minutes Free Consultation
Categories
News

Public Consultation on Medical Devices Clinical Trials Modernization Initiative

Health Canada has published a consultation paper on proposed changes to the regulation and oversight of clinical trials for drug, medical devices and natural health products (NHPs). The purpose of these changes is to improve the speed at which these trials are approved, to avoid stifling medical advances that could help improve the health of Canadians, and to improve transparency and regulatory oversight.

The proposed changes would integrate all health products into the same framework and feature:

  1. Proportional risk-based oversight, 
  2. New regulatory agilities over the lifecycle of the trial, 
  3. Greater transparency through registration and public disclosure of results, and 
  4. A modernized compliance and enforcement regime (see figure 1)

Health Canada is accepting feedback on the proposed changes until 4 July 2021.

Agile Life Cycle

With the adoption of a more agile life cycle approach, Health Canada is looking to be able to give themselves the tools to oversee clinical trials in their entirety while better enabling sponsors to conduct innovative types of trials. As part of these changes, Health Canada will be able to authorize a trial rather than just the sale or importation of an investigational product, authorize a trial with multiple product types through a single authorization, and streamline the application requirements across all product lines for greater efficiency, while maintaining the protection of the health and safety of participants.

Under this scheme Health Canada will allow for the authorization of Master protocols that include multiple sub-studies for different therapies or indications for use. Types of proposed Master protocols include:

  • Basket trials, which investigate the safety/efficacy/effect of an investigational product across a variety of indications
  • Umbrella trials, which investigate the safety/efficacy/effects of several investigational products in a single indication
  • Platform trials, which investigate several investigational products in one or multiple indications in a highly dynamic design

By integrating all health products into a common framework, products from multiple categories can be approved under the same protocol. For medical devices this would result in an expansion of who can sponsor a clinical trial. It will now include independent investigators (such as a researcher, clinician or health care facility) in addition to the manufacturers and importers of medical devices. These changes will also result in any medical device trial being required to adhere to Good Clinical Practices (GCP).

Health Canada is also seeking to improve safety monitoring of clinical trials through improved clarity and increased authority to request information relating to adverse events including the ability to request an analysis of safety data while the trial is ongoing. This may include an assessment of safety signals to determine if the benefit/risk balance has changed during the conduct of the trial.

In this approach, Health Canada will have the ability to suspend or cancel either the whole trial or only a part of the trial if there’s a lack of efficacy or a safety concern.

Risk Based Approach

All health products will follow a common risk-based approach to authorization. To do this they will create risk-based categories with differing levels of oversight and regulatory requirements for drugs and NHPs. The pre-existing risk-based device classification scheme for medical devices will be maintained and integrated into the new scheme. See figure below:

Source: www.canada.ca

Health Canada will be granted the authority to impose terms and conditions on a clinical trial authorization before and during the trial to address significant uncertainties or mitigate risks related to the product(s) being tested, or to the conduct of the trial. These terms and conditions may include:

  • More frequent safety reporting
  • Monitoring of specific populations because of potential increased risk (e.g. children, pregnancy)
  • Additional information to characterise and mitigate newly identified risks.

To allow for greater trial participation from volunteers outside of major urban areas, changes will be made to allow for studies to take place remotely, without a physical visit to a trial site. Monitoring will allowed using videoconferences with investigators, visits at home by study personnel, internet-based tools for data collection and reporting, and mobile technology such as biosensor devices.

Transparency

Health Canada is looking to expand on its current  Clinical Trials Database and is exploring new ways to publish clinical trial information. This may include mandatory registration of any trial conducted in Canada on an existing international registry of Health Canada’s choosing. Sponsors may be required to make results of their trials available to all members of the public by publishing the information in this database. Health Canada is also proposing making this information available on its website to ensure it’s easy to find and available in both official languages.

Modernization of Compliance and Enforcement

Although Health Canada already has the authority to conduct inspections on clinical trial activities under Section 23 of the Food and Drugs Act, its activities have been limited to drugs. As part of the modernization Health Canada will extend its compliance and enforcement to NHPs and medical devices. Inspections will be conducted using a risk-based and pro-active approach based on trial design, the medical condition under study, target population, and the risk classification of the investigational product. Health Canada will also implement a cyclical risk-based inspection approach that considers the compliance history and the volume of activities. Highly compliant entities would be inspected less frequently while less compliant ones would be inspected more frequently.

At present Health Canada only has direct oversight over the sponsors of the trials. Health Canada is proposing regulatory changes that would ensure that all third-parties conducting trials on behalf of a sponsor are legally responsible for any activities they conduct. This would result in increased regulatory burden for these third-parties but will increase the safety of clinical trial participants by allowing Health Canada to require them to take corrective action instead of directing the sponsor to take the action against the third-party.

Anticipated Outcomes for Stakeholders

Health Canada believes these changes will help encourage clinical trials in Canada by providing greater agility in oversight of the development of healthcare products, ensure that regulatory requirements are proportional to risks, improve access to clinical trial information, create a more streamlined approach that is better aligned internationally and leverage partnerships and provide leadership in Canada’s health ecosystem to further facilitate clinical trials in Canada.

Source:
www.canada.ca

How We Can Help

At Quality Smart Solutions, we provide you with the guidance to plan your Veterinary Health Products business, navigate the legal requirements, and acquire the appropriate license for your operations.

Quality Smart Solutions has a team of professionals to offer support from day one of starting your business, including formulation and label reviews, Veterinary Health Product notifications and more.

30 Minutes Free Consultation