Responsibilities of Indian Authorized Agent for Medical Devices Import
An Indian Authorized Agent is an intermediate between the foreign manufacturer and the regulatory authority. Any foreign manufacturer who intends […]
MedTech
Regulations of Reusable Medical Devices under EU MDR
The introduction of the EU Medical Device Regulation (MDR) has brought increased emphasis on robust data and comprehensive evaluations for
Post-Market Surveillance In Medical Device Regulation
One of the biggest accomplishments in the journey of a drug product is its entry into the market as a
Meeting EU Regulations: Role of the European Authorized Representative (EAR)
When foreign medical device and IVD manufacturers seek to distribute their devices within the European Union (EU) Member States, compliance
Medical Device Regulations and Registration in Canada (Health Canada)
In Canada, the medical devices are regulated by Health Canada under Health Products and Food Branch, Therapeutic Products Directorate, Medical
Class III Medical Devices: Meaning, Examples, Approval Process
FDA classifies medical devices into different categories based on their risk factor. Each class of medical device holds different rules and regulations as every one of you would
Types Of Medical Devices & Medical Device Classification System
As we know, the healthcare system and medical devices are co-dependent. The safety and effectiveness of medical devices matters when
Class II Medical Devices: Meaning, Requirements, Process
Running the healthcare system without the use of medical devices is nearly impossible. Medical devices have become an integral part
Class I Medical Device: Regulatory Classification
In the US, Center For Devices And Radiological Health (CDRH) which is a branch of FDA is the regulatory body