Summary: The US FDA 510(k) Premarket Notification submission requires firms to demonstrate that its device is safe and effective by proving substantial equivalence to a legally marketed device (predicate device). Because FDA device classification is not rules based as in the EU, finding a suitable predicate using the FDA database can be challenging. Click here for the Process Chart.

Summary: In Europe, devices are classified using a series of rules found in Annex IX of the Medical Devices Directive (MDD). Therefore, a product considered Class II or III in the USA or Canada might carry a different classification in Europe. Proper evaluation of classification criteria is important and I can assist you in this process. IVDs are classified using the criteria found in Annex II of the In Vitro Device Directive (IVDD). Like medical devices proper classification is important. IVDs follow a similar process to medical devices depending on how it is classified. I can assist you in classifying and submitting your IVD for approval. Click here for the Process Chart. 

Summary: COFEPRIS maintains an extensive list of medical devices, and each product on this list has a corresponding code that determines its classification (Class I, II or III). Selecting the proper classification code is critical to the registration process. A completed COFEPRIS registration dossier contains similar information found in US FDA and Health Canada submission documents. Click here for the Process Chart.

 Summary: When compared to the US FDA 510(k) registration process, the process of securing a Canadian Medical Device License is usually quicker for Class II devices, roughly the same for Class III devices and typically more complicated for Class IV devices. If you sell Class I devices and ship directly to customers in Canada rather than through an established distributor, a Medical Device Establishment License is required. Selling through a distributor requires no MDEL, but you still need to follow the Canadian Medical Devices Regulations. Click here for the Process Chart.

Summary: Like in other countries, determining the proper classification for your medical device is the first and most critical step to ensuring a smooth registration process. Like a US FDA 510(k) submission, the Brazilian Technical File provides proof that your product is safe and effective. If you manufacture an electro-medical device, electrical safety testing and INMETRO certification may be required in Brazil. Click here for the Process Chart. 

Summary: Japan’s device  classification system differs from the US and EU making determining classification of your device  complex. Classification is based on Japanese Medical Device Nomenclature (JMDN) codes. Japan’s Pharmaceutical and Medical Devices Agency (PMDA) requires manufacturers to prepare pre-market applications (Class II, III and IV) plus registration dossiers in Summary Technical Document (STED) format, etc. and pre-market submission (Class I). Japan does not accept European CE Marking certificates or national ministry approvals although European, US or Canadian approval aids the registration process. Click here for the Process Chart. 

Summary: Device classification in China is anything but a straightforward process. Class II devices in Europe or the USA might be Class III in China, which can dramatically change the cost and time needed for registration. If you wish to import a medical device into China, a specific Registration Standard document must be prepared and submitted along with product samples for testing. Click here for the Process Chart.

1. Quality Systems Regulations
2. Food Drug and Cosmetic Act – Medical Devices
3. Medical Device Reporting

1. Medical Device Directive 93/42/EEC
2. In-Vitro Diagnostic Devices Directive (98/79/EC) 

 Coming Soon!

1. Canadian Medical Devices Regulations – SOR 98-282
2. Medical Devices Active Licence Listing (MDALL)
3. Quality Systems ISO 13485

 Coming Soon!

 Coming Soon!

 Coming Soon!