canada

ISO 13485:2016 is the most current version of the Quality Management System (QMS) for Medical Device manufactures which is based on the ISO 9001:2008 standard.  

On February 25, 2016, the International Organization for Standardization published the 2016 version replacing the 2003 version giving a three year transition period which ended on February 28, 2019. All manufacturers are required to comply to this new standard as of this effective date.  

The impact of the 2016 standard to the medical industry will facilitate;

a) Improved alignment with   global regulatory requirements,

b) Incorporation of risk management and risk based approach throughout the QMS and emphasized throughout product life cycle including outsourced processes

c) More explicit requirements for software validations, and

d)  Additional requirements to validation, verification and design activities.

Medical Device Single Audit Program (MDSAP) is an international initiative led by five Regulatory Authorities to implement a program where MDSAP recognized Auditing Organizations (AO) can conduct a single regulatory audit of a medical device manufacturer to satisfy the relevant regulatory requirements for upto five different medical device markets: Australia, Brazil, Canada, Japan and the United States.

The MDSAP program  provides efficient and thorough coverage of the requirements of ISO 13485:2016, Medical devices – Quality Management Systems – Requirements for regulatory purposes, Australian Therapeutic Goods (Medical Devices) Regulations (SR 236, 2002), the Brazilian Good Manufacturing Practices (RDC ANVISA 16/2013), the Canadian Medical Device Regulations (SOR/98-282), the Japanese QMS ordinance (MHLW MO 169), and the United States FDA Quality System Regulation (21CFR 820).

* Canada - Health Canada, as of January 1, 2019 will only accept MDSAP certificates for the purpose of obtaining a new (or maintaining an existing) Class II, III or IV medical device licence.

We at Medical Device Advice, Inc., have experienced consultants who can evaluate your current system to determine your level of compliance to ISO 13485:2016/MDSAP and pave a pathway for a successful transition to this new standard. 

We can also perform a gap analysis to identify any deficiencies or non-conformities within the current system and assist you to upgrade and meet the current requirements.

Good Manufacturing practices guide for drug products (GUI-0001) are guidelines that interpret the requirements for Good Manufacturing Practices (GMP) in Part C, Division 2 of the Regulations. 

These guidance documents help the industry to comply with the regulations and Health Canada staff to enforce these requirements in a fair and consistent manner.

If you fabricate, package, label, import, distribute, test and wholesale drugs you need to comply with these regulations.

We at Medical Device Advice, Inc., can help you design and implement the pharmaceutical quality system that incorporates the good manufacturing practices (GMP) and quality risk management (ICHQ9: Quality Risk Management).

We can also perform a gap assessment to the current requirement and identify any non-conformities and assist you in addressing each one of them. This will keep you audit ready for any Health Canada inspections

Our consultants can also help you implement appropriate corrective actions to address non-conformities that have risen from Health Canada inspections and help you maintain a compliance rating.

Medical Device Regulations (SOR/98-282) of the Food and Drugs Act Part 1, sections 44 to 51.1 explains the Medical Device Licensing Requirements.  

Medical Device Establishment Licence (MDEL) is required by any person who imports into Canada, or sells a medical device for human use in Canada . 

MDEL requirement does not apply to the following:

● Retailers

●  Healthcare Facilities

●  Manufacturers of class II, III and IV medical devices

●  Manufacturer of a class I device if imported or distributed through a person who holds the establishment licence

We at Medical Device Advice, Inc., can help you determine if a device is classified as a medical device and determine the classification of the device.  

If you are importing or distributing medical devices, application must include the information of the manufacturers. 

Our consultants can assist you complete the MDEL application form and submit to the Inspectorate. 

We can also assist you with annual renewals, which must be completed by April 1st of each year.

As of January 1, 1998, all Canadian Drug Establishments must hold an establishment licence to fabricate, package, label, distribute, import, wholesale or test a drug. In addition a person who wishes to fabricate, package, label, test or import an active pharmaceutical ingredient, in Canada, is required to hold a Drug Establishment Licence. All sites that hold the Drug Establishment site must be in compliance to the Good Manufacturing Practices. 

Our consultants at Medical Device Advice, Inc., can help you file the Drug Establishment Licence (DEL) applications with Health Canada,  assist you with your annual renewal applications, and also help you determine the annual fee payable to Health Canada.

Medical Devices in Canada are classified on a risk-based classification system and grouped into four different classes. Generally the higher the risk of the medical device, the higher the classification of the device.

Medical Device Regulations SOR/98-282 Schedule 1, Part 1 details the classification rules for non-In VitroDiagnostic Devices (non-IVDDs). There are 16 rules governing the classification of non-IVDD’s, as follows:

●  Rule 1 to 3 - Invasive Devices

●  Rule 4 to 7 - Non-Invasive Devices

●  Rule 8 to 12 - Active Devices

●  Rule 13 to 16 - Special Rules

The first step in determining the classification of a device is to review special rules 13 to 16. If the device in question is not described by any one of these Special Rules, then it needs to be determined if the device is invasive, non-invasive or active. 

There will be situations where a device can be invasive and active or non-invasive and active. In these cases more than one rule will apply, however the rule that governs the higher risk will be considered as the final device classification in these situations. 

Our consultants at Medical Device Advice, Inc., can assist you in determining the classification of your device based on the risk of the medical device. 

All manufacturers prior to selling in Canada must obtain a medical device licence for all class II, III and IV devices. 

All devices are categorized based on the risks associated with their use. Rules to classify medical devices are outlined in schedule 1 (Part 1) of the Medical Device Regulation SOR/98-282 for non-IVDD’s. 

Class I devices do not require a Medical Device Licence, however all manufacturers, importers and distributors are required to obtain a Medical Device Establishment Licence. An application for a medical device licence for class II, III and IV must be submitted to the ministry by the manufacturer, in accordance with the Medical Device Regulations SOR/98-282 Part 1, Section 32. 

All applications must be accompanied by the ISO 13485:2016/MDSAP Quality Management System Certificate.  

Manufactures of class II medical devices must attest that they have objective evidence establishing that they are compliant with sections 10-20, Safety and Effectiveness requirement  of the MDR, along with a copy of the label and ISO certificate to be submitted. 

For class III medical devices above requirements must be met along with a list of countries other than Canada, where the device has been sold, the quantity and a summary report on adverse events and recalls. In addition, a summary of all studies performed to demonstrate the safety and effectiveness of the device, as outlined in section 10-20 of the MDR must submitted. 

For all class IV devices, in addition to the documents mentioned above, risk assessment study undertaken to address the safety and effectiveness in section 10-20 of the MDR must be provided along with a complete specification of the materials used in the manufacturing and packaging of the device, manufacturing process of the device, pre-clinical and clinical studies, process validations studies, appropriate software validation and literature studies.  

We have experts, at Medical Device Advice, Inc., who can assist you in the determination of the classification of the devices and filing the appropriate medical device licences, whether its for a class II, III or IV device.  

We can also help you determine the appropriate fee that would be required for the applications, and also provide assistance with private label medical device applications and renewals. 

Canadian Medical Device Regulations SOR/98-282 Section 57-58, provides guidance on investigation of Medical Device Problems (Complaint Handling).  

Manufacturers, Importers and Distributors of a medical device must have established procedures that will facilitate effective and timely investigation of product complaints. Risk management principles must be incorporated into the investigation process.

Manufacturers will take the lead in investigating and resolving the problem by performing a root cause investigation including  risk analysis and taking appropriate risk control measures (recalls, corrective and preventive action).  Importers, however, for complaints involving device safety or performance, will gather all relevant information, make a preliminary risk estimation, comply with mandatory reporting requirements and submit all reports to the manufacturer for further root cause investigation and risk analysis. 

Distributors have the same responsibility as the importers for investigating complaints, however have no responsibility for mandatory reporting. 

Canadian Medical Device Regulations SOR/98-282 Section 59-60 of the MDR, provides guidance on mandatory problem reporting. 

All manufacturers and importers must submit a preliminary and a final report to Health Canada on any adverse event related to their device that they become aware of occurring within and outside Canada.  

An incident is reportable when the incident,

a) Occurs either within or outside Canada

b) Relates to a failure of the device or deterioration in its effectiveness, or any inadequacy in its labeling or in its directions for use

c) Had led to the death or a serious deterioration in the state of health of a patient, user or other person, or could do so if it were to recur.

A preliminary report must be submitted to Health Canada within 10 days if the device has caused a death or a serious deterioration in health, or within 30 days if no death or serious deterioration has been reported but could do so if it were to recur.

Our consultants at Medical Device Advice, Inc., can help you determine if an adverse event is reportable to Health Canada and if found reportable we can complete and file the Mandatory Medical Device Problem Reporting Form for Industry with Health Canada.  

If you are lacking procedures in customer complaint management or mandatory problem reporting we can help you develop procedures that are in compliance to the regulations.

We can also assist you in root cause investigation, risk analysis and taking appropriate risk control measures (corrective and preventive action/recalls).

Canadian Medical Device Regulations SOR/98-282 Section 63-65.1 provides guidance on Recalls for Manufacturers and Importers. 

A recall is defined in the MDR as any action taken by the manufacturer, importer or distributor of the device to recall or correct the device, or to notify its owners and users of its defectiveness or potential defectiveness, after becoming aware that the device,

●  may be hazardous to health,

●  may fail to conform to any claim made by the manufacturer or importer relating to its effectiveness, benefits, performance characteristics or safety,

●  may not comply with the Food and Drugs Act or these regulations.

All Manufacturers, Importers and Distributors and all establishments holding Medical Device Establishment Licences are required to maintain recall procedures and distribution records, however, only manufacturers and Importers are required to report recalls to Health Canada.

The Recall process is divided into 5 stages:

Stage 1- Identify the need to initiate a recall,

Stage 2 -Develop recall strategy and scope,

Stage 3 - Notify and correct,

Stage 4 - Follow up,

Stage 5 - Review and close recall. 

We, at Medical Device Advice, Inc.,  have the expertise and knowledge to help you establish recall procedures and maintain distribution records as per the Medical Device Regulations. 

We can also help you define a strategy for the recall, and help you evaluate the risk associated with the defective device, and determine the health hazard classification for the recall. 

Our team can  help you determine if any corrections made to a class III or IV device constitute a significant change requiring an amendment to the existing medical device licence.  

We can assist you in drafting the communication letter to the customer informing of the recall and any follow up actions required. 

Assistance can also be provided in keeping track of all returned items and performing an effectiveness check on each action required under the recall. 

Our experts can also assist you in the preparation of the final recall report for submission to Health Canada.

Canadian Medical Device Regulations SOR/98-282 Section 21 -23 provides guidance on Labeling Requirements for non-in vitro Diagnostic device.  

No person can import or sell medical devices in Canada without meeting these labelling requirements.

Labeling for devices sold to the general public must be set on the outside of the package and must be both in English and French.  

All medical devices must show the following information on the labels:

*The name of the device,

* The name and address of the manufacturer,

* The identifier of the device,

* Control number for class III and IV devices

* An indication of what the package contains if the contents are not readily apparent,

* The word “sterile”, if the intent of the product to be sold in a sterile condition,

* The expiry of the device,

* The intended use of the device, unless self evident,

* Directions for use, unless not required,

* Any special storage that is applicable to the device.

We, at Medical Device Advice, Inc., have experts who are very familiar with the labelling requirements and can assist you in drafting your labels for non-in vitro diagnostic devices.

As per the Natural Health Product Regulations SOR/2003-196 , all Natural Health Products (NHPs) must have a product licence, and the Canadian sites that manufacture, package, label and import these products must have site licences. These requirements do not apply to healthcare practitioners who compound products on an individual basis for their patients, or to retailers of NHPs.

 In order to obtain a product licence, detailed information including medicinal ingredients, source, dose, potency, non-medicinal ingredients and recommended uses (s) must be provided to  the Natural and Non-Prescription Health Products Directorate (NNHPD). Once the product licence application has been assessed and granted market authorization by NNHPD, the product label will bear an eight digit product licence number preceded by the distinct letters NPN (Natural Product Number), or in the case of a homeopathic medicine, by the letters DIN-HM.  These numbers must appear on the front panel of your label and informs the end user that these  products have been reviewed and approved by the NNHPD. 

The safety and efficacy of NHPs and their health claims must be supported by proper evidence so that consumers and Health Canada know the products are indeed safe and effective.  Evidence may inlcude clinical trial data or references to published studies, journals, pharmacopoeias and traditional resources. 

Monographs have been developed to support the safety and efficacy of commonly used NHP ingredients.  There are three classes of applications, which are differentiated by their use of NNHPD monographs.

* Class 1  - is comprised of products that comply with all parameters of an individual NNHPD monograph and can reference only one NNHPD monograph per application. 

*Class II- are general and traditional applications supported entirely by a combination of 2 or more NNHPD monographs as well as the following scenarios:

      - Applications supported entirely by an individual NNHPD monograph with a deviation to one or more monograph statements 

     -Applications supported entirely by a combination of NNHPD monographs with a deviation to one or more monograph statements 

     -Products supported entirely by a combination of NNHPD monographs with the addition of common fruits or vegetables listed in the Canadian Nutrient File

*Class III- are comprised of general, traditional and homeopathic applications requiring full assessment including the following:

       -Products with a novel preparation and/or dosage delivery system presenting unique safety and/or efficacy profiles.

      - Applications referencing a Master File to support safety, efficacy and/or quality

     -Products with ingredient combination issues

     -Applications partially referencing monograph information but going beyond the parameters established in the relevant monographs. 

Our experts at Medical Device Advice, Inc., can assist you with the following:

* Assessment of all facilities for compliance to the Good Manufacturing Practices (SOR/2003-196, Part 3)

*Creation of standard operating procedures for the implementation of the cGMPS

*Preparation and submission of Natural Health Product Licence and Site Licences applications/renewals

*Application preparation for Foreign Site Reference Numbers (FSRN)

*Pre-Submission Meeting Request

*Review label for compliance

As NNHPD is migrating towards a full electronic application process, our consultants at Medical Device Advice, Inc., will facilitate all communication through epost Connect and will also help in registering you as a Trading Partner so new applications can be submitted without signatures on the document.