Medical Devices

Navigating the regulatory requirements for medical device registration can be complex and time-consuming, but it is essential to ensure your products meet safety standards and are legally available in the market. We offer expert medical device product registration services, helping manufacturers and distributors bring their medical devices to market smoothly and efficiently.

From classifying your medical devices according to local regulations to handling the submission process, we provide a comprehensive range of services to ensure that your products are compliant with the regulatory authorities, enabling timely approval and distribution.

Services include:

• Regulatory Compliance Consultation: Advise on the local and international regulatory requirements for your medical devices, helping you understand specific rules and guidelines in your target markets.
• Device Classification: Assist in determining the correct classification of your medical device according to local regulations, ensuring that you follow the appropriate approval process based on the device’s risk category.
• Document Preparation & Submission: Prepare and submit the necessary documentation for medical device registration, including technical files, safety and efficacy data, labeling, and risk management reports.
• Clinical Trial Support: If required, help organize and manage clinical trials, ensuring that your product meets safety and performance standards before it is approved for use.
• Registration with Regulatory Authorities: Handle the complete registration process with relevant regulatory bodies, such as the FDA (U.S.), CE (Europe), Health Canada, and other national or international agencies, to ensure your product meets the required standards.
• Labeling & Packaging Compliance: Review and update your product labeling and packaging to comply with regulatory guidelines, including necessary warnings, instructions for use, and country-specific requirements.
• Quality Management System (QMS) Guidance: Assist in implementing or reviewing a Quality Management System (such as ISO 13485) to meet regulatory standards and ensure your manufacturing processes are compliant.
• Post-Market Surveillance: Help establish a post-market surveillance plan to monitor the safety and performance of your medical device once it’s on the market, ensuring ongoing compliance and reporting of any adverse events.
• Regulatory Strategy & Market Entry: Develop a comprehensive strategy for entering new markets, advising on the best approach for registering your products and obtaining approvals in various regions.
• Renewals & Updates: Manage the renewal of product registrations, ensuring that your devices remain compliant with changing regulations and that updates to your products (such as new features or packaging changes) are properly reported.
• Regulatory Affairs Support: Offer ongoing support for any regulatory inquiries, inspections, or audits, ensuring your company maintains compliance and successfully navigates any challenges that arise.

With our product registration services for medical devices, we help you streamline the process of bringing your medical products to market, ensuring compliance with local and international regulations and safeguarding your product’s success. Let us take care of the regulatory paperwork and requirements so you can focus on the innovation and impact of your medical device.