Welcome to Safetek’s Regulatory Correspondent Services! Trust us for comprehensive support in managing medical device regulatory communications across regions.

Australian Sponsor Services

If you are seeking to market your medical devices in Australia, our consultancy organization offers Australian sponsor services. We assist you in finding a qualified sponsor who acts as a local representative and takes responsibility for your medical device's regulatory compliance in Australia. Our team ensures that the sponsor fulfills the required obligations and maintains the necessary records as per the Australian regulatory framework.

Marketing Authorization Holder (MAH) Services

For medical device manufacturers aiming to distribute their products in Japan, our consultancy provides MAH services. We guide you through the process of appointing a MAH, who serves as the legal entity responsible for regulatory compliance in Japan. Our experts assist in identifying a suitable MAH and ensure that the necessary agreements and documentation are in place to facilitate smooth market entry in Japan.

EU Representative Services

With the implementation of the European Union Medical Device Regulation (EU MDR), non-EU manufacturers must appoint an EU representative to act on their behalf within the European Union. Our consultancy offers EU representative services, assisting you in finding a qualified representative who will fulfill the regulatory obligations outlined in the EU MDR. We ensure that the representative maintains accurate documentation and acts as a reliable point of contact for regulatory authorities in the EU.

Australia Regulatory Framework

Following the United Kingdom's departure from the European Union, medical device manufacturers outside the UK need to appoint a UK representative. Our consultancy provides UK representative services, supporting you in identifying a reputable representative to handle regulatory matters in the UK market. We ensure that the representative understands the UK regulatory requirements and maintains compliance with the applicable regulations.

US Agent Services

If you are a medical device manufacturer outside the United States, our consultancy offers US agent services to assist you in complying with the US FDA regulations. We help you select a qualified US agent who serves as your authorized representative for FDA communications. Our experts ensure that the agent meets the necessary criteria and facilitates effective communication with the FDA regarding regulatory submissions and compliance matters.

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