What is the difference between Canadian medical device certification and US fda certification?

MEDevice Services, LLC All medical devices entering the Canadian market for sale, whether locally manufactured in Canada or imported, need to be licensed by Health Canada, the Canadian medical device authority.　　Canada's medical regulatory system utilizes a product registration system. Unlike the U.S. Food and Drug Administration (FDA), where the government has a single-handed approach, i.e., government product registration coupled with government on-site review (GMP review), and unlike Europe's full third-party Notified Body inspection system (CE marking), Canada implements a combination of government registration and third-party quality system review. The third party here refers to the third-party organization accredited by the Canadian Medical Devices Certification and Accreditation Service (CMDCAS, Canadian Medical Devices Conformity), hereinafter referred to as CMDCAS accredited organization. Canadian Medical Devices Conformity classifies medical devices into four categories: I, II, III, and IV, in order of risk, such as Class I devices are the lowest risk and Class IV devices are the highest risk.　　　For this reason, the product registration requirements for manufacturers are also increased by level, requiring manufacturers to implement the system is more and more detailed. For example, Class I medical devices are exempted from registration, and the registration requirements for Class II, III, and IV devices are as follows: 1. General registration information: a) Name of the device; b) Classification of the device; c) Marking of the device; d) Name and address of the manufacturer appearing on the label of the product; e) If the place of manufacture is different from d), then the name and address of the place of manufacture; 2. Additional information for the registration of Class II devices: a) Manufacture, sale, or distribution of the device for medical conditions; b) The name and address of the manufacturer. a) A description of the purpose and use of the device manufactured, sold or brokered for medical conditions; b) A list of the standards met to satisfy the requirements for safety and efficacy; c) A statement of compliance with safety and efficacy by a senior executive of the manufacturer; d) A statement of compliance with the Canadian Medical Devices Regulations in the labeling of the device by a senior executive of the manufacturer; and e) In the case of near-patient in-vitro diagnostic devices (i.e., devices that are not intended for use in hospitals but are intended for use, for example, in the home), the manufacturer's senior executive's statement of compliance. e) in the case of near-patient in vitro diagnostic devices (i.e., devices not intended for use in hospitals but, for example, in the home), a statement by a senior executive of the manufacturer that investigational testing has been performed with human substances representative of the intended user under conditions similar to those of the intended use; and f) a CAN/CSA-ISO 13485-98 system certificate issued by a CMDCAS accredited body.　　3. Additional conditions for registration of Class III devices: a) a description of the device and the materials used in its manufacture and packaging; b) a description of the performance of the device as manufactured, marketed and distributed under its permitted medical conditions, purposes and uses; c) a list of countries other than Canada in which the device has been approved for sale, the number of units sold, and reported problems and recalls; d) a list of the standards used in the design and manufacture of the device to satisfy the safety and effectiveness; e) a list of the standards used if the device is designed and manufactured to satisfy the safety and effectiveness criteria; and safety and effectiveness; d) a list of standards used in the design and manufacture of the device to meet safety and effectiveness; e) if the device is sold sterile, a description of the sterile method; f) a description of studies conducted by the manufacturer for safety and effectiveness and the conclusions drawn therefrom; g) a copy of the labeling/copies of the device; h) in the case of near-patient in-vitro diagnostic devices, the testing of the device in studies using human substances representative of the intended users under conditions similar to the conditions of use; and I) all publicly available information relevant to the use of the device, i) Literature citations of all publicly available reports related to use, safety and effectiveness; j) CAN/CSA-ISO 13485:98 certificate issued by a body accredited by the Canadian Medical Devices Accreditation Body.　　4. The additional materials for Class IV medical devices are: a) a description of the device and all materials used in its manufacture and packaging; b) a description of the device characteristics for the medical conditions, purposes, and uses for which the device is manufactured, marketed, or distributed; c) the countries in which the device has been approved for sale other than in Canada, the number of units sold, and the status of reported problems with, and recalls of, the device; d) a risk assessment that includes an analysis of the risk, an evaluation of the risk, and an assessment of how well the risk meets the safety and efficacy requirements; e) a description of the risk assessment, including the risk analysis, the risk evaluation, and the evaluation of how well the risk meets the safety and efficacy requirements. d) Risk assessment including risk analysis, risk evaluation, and measures to meet safety and efficacy requirements for evaluating risk; e) Quality program related to the device, such as specific quality practices, resources, and procedures for taking action; f) Parameters of materials used in manufacturing and packaging; g) Manufacturing process for the device; h) List of standards used in the design and manufacture of the device to meet the safety and efficacy requirements; and I) Details of all studies conducted by the manufacturer to demonstrate that the safety and efficacy requirements are met. i) details of all studies carried out by the manufacturer to demonstrate that the safety and effectiveness requirements are met, including: i) preclinical and clinical studies; ii) process validation studies; iii) software validation studies, where applicable, and iv) literature studies; j) in the case of a device other than an in vitro diagnostic device, objective evidence of biosafety for a device derived from animal tissues or tissue derivatives; k) details of research tests carried out, in the case of a near-patient in vitro diagnostic device, for a human body substance representative of the intended user under similar conditions of use; and k) in the case of a near-patient in vitro diagnostic device, details of research tests conducted on human substances representative of the intended user and under similar conditions of use; l) the manufacturer's conclusions based on the research in paragraph (I); m) a general description of the manufacturer's research in accordance with paragraph (h) and the conclusions drawn therefrom; n) publicly available published reports of the literature relevant to the use, safety, and efficacy of the device; o) a copy of the labeling of the device; and p) CAN/CSA-ISO 13485:98 certificate issued by a body accredited by the Canadian Certification Authority for Medical Devices (CCAD). 13485:98 certificate.　　Following the issuance of a medical device license, reconfirmation shall be submitted by the manufacturer to Health Canada on November 1 of each year. Cancellation of a manufacturing license should be submitted within 30 days of the cessation of sales in Canada.　　In addition, Health Canada operates a business license system for entities that import or sell medical devices.　　An application for a license to operate should include the following: a) the name/address of the business unit; b) the name, title and telephone number of a representative of the business unit who will act as a contact person for the situation; c) a description of the business unit as an importer or distributor, or both; d) the name and address of the manufacturer of the medical device being imported or distributed; e) for each manufacturer, the name and address of a medical expert listed in a pool of experts designated by the Department of Health to work with the importing or distributing f) For each manufacturer, the classification of the imported or sold device; g) A declaration by a senior official of the business unit that the business unit establishes and maintains documented procedures relating to distribution records, complaint handling and recalls; h) If the business unit imports medical devices, a declaration by the senior official that the business unit complies with the mandatory adoption of the reporting system; i) When the business unit imports or sells Class II, III or IV medical devices, a declaration by the senior official that the business unit complies with the mandatory adoption of the reporting system IV medical devices, the senior officer declares the establishment of documented procedures to control the handling, storage, delivery, installation, corrective action and servicing of those devices; j) the implementation of subsections (g) to (I) for each address in Canada.　　The operating permit is voided on December 31 of each year, and the business unit shall submit a reapplication. In addition, similar to U.S. and European regulations, the Canadian Medical Devices Regulations require operating units and manufacturers to implement an incident alert reporting system.