Device Registration Worldwide

The European, South Korea, or Brazil – every market has different requirements that manufacturers and exporters of medical devices must meet. Getting to grips with the current applicable directives and standards is complex, but advantageous.

Tox Regulatory Advisor can assist you access new markets and obtain medical device approvals in  the following regions/ countries:  EU , Canada, Australia, US, Brazil, Israel, South Korea, Japan, Taiwan, China, Russia, Saudi Arabia, South Africa, Argentina,  India, Indonesia, Mexico and Kenya  etc.

Our medical device registration specialists have well-established relationships with local competent authorities in these markets and have vast experience on how to register Class I, II or III medical devices, in order to obtain medical device approval as efficiently as possible.

Risk Classification

• We ensure that you comply with the correct legislations, applicable standards and guidelines, by determining the risk classification of your device in the targeted markets.
• Strategic regulatory plan
• We identify the optimal conformity route to CE marking, upon confirming the intended purpose and classification of your device, as well labelling requirements.

CE certification

• By being your liaison with the competent authorities and the Notified Body, we handle the responsibility of coordinating the registration and approval of your device.