Global FDA 510(k) Services
International FDA 510 K Clearance
CE Mark Consultants and CE Marking Strategy for New Medical Devices
What is the CE Marking Used For?
The CE Marking is a legal agreement displayed by the manufacturer on their new device or product, stating that they have met all of the compliance standard of the Medical Devices Directive.
If you plan on marketing your new medical device or product in Europe, there are several requirements that you must meet in order to facilitate the official CE Marking certification and registration of your new product or device.
The Official CE Marking Checklist:
MDD requirements checklist that needs to be met before CE marking can be applied on your new device or product:
-Create a CE Marking Folder and collect all documentation of compliance as highlighted by the Medical Devices Directive.
-Request a CE Mark certificate, contingent upon applicable devices or products.
-You must hire an In-country agent if you do not have a physical business location within said country.
-You must also finish the registration process by registering your new device or product with all applicable EU Competent Authorities and governing regulatory bodies.
After completing all of the above listed criteria then you will be able to install the CE Mark on your new product(s) and/or device(s).
Our CE Marking Services:
-CE Marking Technical File / CE Design Dossier instruction, assistance, and review services.
-Complete verification process of all documentation provided, product review, and product labeling / packaging review
-Product classification and identification of applicable standards for medical devices.
-ISO 13485 services
-ISO 14971 services
-New Medical Product / Device- Pre-Market and Post-Market Surveillance and Vigilance SOP services
-In country agent services
Our medical device consultants will assist you with setting up a custom medical device compliance system that is accepted by the European Directives for Medical Devices, the U.S. FDA, the Canadian Medical Device License, the Australian TGA, and the Japanese P.A.L.
European Technical File-
What Information Has to Be in the CE Mark Technical File
- Classification of Device/Product and Evidence As To Why the Device Fits a Particular Classification.
- Highlight the intended use(s) of the device
- Complete description of device – materials, packaging, and any related manuals or instructions
- How was the device or product manufactured?
- Any Accessories ?
- Who? What? Where? Information on all designers/engineers, developers, and manufacturers that worked on device/product.
- Lifetime/shelf life of products
- Environmental Issues, Risks, and Concerns
- Complete records for Quality Assurance, Device Testing, Safety, and Risk Mitigation.
- Competent Authority Records
- Notified Body Records
- Vigilance Reporting
- Medical Device Reporting
- Contact Information on Competent Authorities
- Contact Information on your Authorized Agents
- Essential Requirements checklist
- Instructions for Use of Device / Product and Labeling
- Actual Application and Qualified List of References
CE Technical File or Design Dossier services-
-Create the Technical File or Design Dossier
-Assistance with consolidation of all documentation and data
-In depth review of all documentation and data to support all applicable Essential Requirements Directives
-research any applicable standards and calculation for Risk Assessment
-Review user manuals, instructions, and device/product labeling
-Create a risk management program
-Help with writing and proof reading the clinical evaluation summary.
Contact Us Today for More Information On Our CE Technical File and Design Dossier Services
Health Canada Medical Device Licenses-
Canada Medical Device License (MDL / MDEL) – Overview
Any company interested in marketing their medical devices in Canada should know that there are only two types of licenses issued by Health Canada (the Canadian version of the U.S. FDA) for medical devices.
Health Canada Medical Device Establishment License (MDEL)
If you are a manufacturer of Class 1 medical devices and plan on selling your new medical devices in Canada without a distributor, then you must file for a Medical Device Establishment License. If you are selling any class of medical devices and products through distributors in Canada, then the distributors, importers, and resellers will have to file for the MDEL.
Health Canada Medical Device License (MDL)
The Health Canada MDL is required for manufacturers of Class II, III, and IV medical devices. The Medical Device License(MDL) is for the new product or device approval. Please note that the MDL is for the new product/device and the MDEL is for the actual business entity that manufactures, distributes, resells, imports, or re-brands new medical devices and products that are to be sold in Canada.
The Health Canada Canadian Medical Device License is only issued to companies that can display that they have a current operating certified ISO13485 system in place that meets or exceeds the Canadian Medical Device Regulation requirements, CMDR/CMDCAS. Our medical device registration consultants will be able to assist you with compliant ISO systems for your new medical devices and products.
Our MDL and MDEL Services-
- Research of Classification for the New medical Device for other approved similar predicate devices.
– Calculate the annual establishment and device fees to be paid to health Canada
– Collecting all pertinent documentation and filing of applications for the Canadian Medical Device License (MDL) and / or the Canadian Medical Device Establishment License (MDEL).
-ISO 13485 – Set up, execution of, and/or modification of new or existing ISO systems for CMDR compliance.
-On site ISO training for staff for CMDR Compliance
-Provide onsite auditing to confirm compliance with ISO 13485 and CMDR.
Contact us now to request more information on our Health Canada medical device license application consulting services.
China CFDA/SFDA Clearance and Approval Processes for Medical Devices-
China SFDA/CFDA Approval for Medical Devices
Do you need assistance with getting an approval for your new medical devices and products? Our CFDA medical device consultants will work tirelessly to collect all information, documentation, testing data, and application information for review, finalization, and submission of the complete medical device application. We will then keep in contact with you and the CFDA to consult, guide, and answer any questions or concerns the CFDA may have in terms of any compliance issues that may arise from your new medical device CFDA clearance application.
Our CFDA Consulting Services-
- Research classification of device and similar approved devices/products.
- Research the most efficient route to take for rapid CFDA medical device approval.
- Define and develop product registration standards.
- Assist with device/product testing, if applicable.
- CCC Mark services- only for applicable devices/products
- Collect, review, prepare all information and documentation for the final submission service to the CFDA
- In country Liaison, Legal Agent, and After Sales Agent Services-Translation services for new device documentation, manuals, and labeling
Need a CFDA approval to market your new medical device in China?
Contact us for more information on our CFDA medical device consulting services
ANVISA Device Registration-
ANVISA Medical Device Registration and Approval in Brazil
The initial steps to registering your new medical device in Brazil is to document the product classification, find similar approved products that are already out on the Brazil market, and start consolidating all data, information, and documentation into a technical file.
- Most medical devices that are powered by electricity will more than likely need an INMETRO certification
- Class III and IV medical and dental device manufacturers require Brazil GMP certification.
Our ANVISA Services-
Our ANVISA consultants will assist you with initial research, documentation, testing assistance, INMETRO certification; developing, implementing, and/or updating your current quality compliance systems, assist with any additional testing or information requests from ANVISA, and represent your company as the certified Brazilian Registration Holder.
Brazil’s device registration timeline
Most ANVISA applications are cleared for approval within a period of 6-12 months, some of the more hazardous medical device classes can take upwards of 4 years due to additional registration and ANVISA’s current backlog of pending applications and registrations. These forecast time frames do not include the actual preparation time of the ANVISA application, assembling of the Brazilian Technical File, and any necessary document translations.
NOTE- Sometimes there are several additional steps to be taken when seeking an ANVISA medical device approval.