In the medical device industry, compliance is a critical threshold for entering global markets. Luminova Medical Technology Co., Ltd., as a professional CDMO provider, is dedicated to offering comprehensive compliance support as a supplier or manufacturer. Leveraging advanced production facilities, a rigorous quality management system, and a skilled team, we assist clients in navigating the registration and certification processes across various markets, ensuring seamless product compliance and market access.

Our Compliance Support Services

Through collaborations with multinational medical device companies, biotech firms, and startups, we deeply understand the vital role of a supplier in the compliance process. Luminova’s compliance support services focus on providing production-side technical assistance and documentation to meet the requirements of regulatory authorities worldwide. Our services include, but are not limited to:

1. Preparation and Provision of Technical Documentation
   We prepare and provide technical documents required for registration invarious countries, such as product specifications, manufacturing processdescriptions, raw material details, and quality control data. Thesedocuments undergo rigorous review to ensure compliance with standards likeChina’s NMPA, FDA, and CE MDR, laying a solid foundation for our clients’registration applications.

2. Testing and Validation Support
   As a manufacturer, we actively collaborate with clients or third-partyorganizations to conduct essential tests, including bio-compatibility,performance validation, and sterility assessments. We supply detailed testdata and reports to ensure products pass compliance reviews smoothly.

3. On-Site Audit Support
   When clients face regulatory inspections or supplier audits, we providefull cooperation, including preparing production sites, organizingdocumentation, and facilitating communication with auditors. Our Class100,000 clean-rooms and Class 10,000 laboratories meet internationalstandards, fulfilling the stringent demands of audits.

Our Compliance Capabilities

1. Robust Quality Management System
   Luminova strictly adheres to international quality standards such as GMPand ISO 13485:2003. Our professional quality team ensures productioncontrollability and traceability, supported by MES and ERP systems thatmonitor production data in real-time, bolstering compliance.

2. Extensive NMPA Registration Experience
   Our team is well-versed in the registration processes and requirements ofChina’s National Medical Products Administration (NMPA), providingproduction documentation and support compliant with local regulations toaccelerate product launches in the Chinese market.

3. Support for FDA and CE MDR Registration
   For FDA and CE MDR registration needs, we work closely with third-partypartners, supplying technical documents and data that manufacturers canprovide. While specific FDA and CE guidance is handled by externalexperts, we ensure production-side compliance and documentation integrity,saving clients time and costs.

Compliance Support Process

• Needs Assessment:Clarifytarget markets and registration requirements with clients to define thescope of technical support.

• Documentation Preparation:Provide production-related technical documents, such as process flowchartsand quality inspection reports, per regulatory standards.

• Testing Coordination:Collaborate with clients or third parties to complete required tests andsupply supporting data.

• Site Preparation:Prepareproduction facilities and documentation for regulatory or client audits.

• Ongoing Support:Offersustained compliance assurance post-registration to ensure supply chainstability.

Our Advantages

1. Production-Side Expertise
   With over 20 years of experience in manufacturing enteral nutritionproducts and endoscopes, we understand the critical role of production incompliance. From raw material selection to process optimization andquality control, we deliver technical support aligned with internationalstandards.

2. Flexible Collaboration Model
   Recognizing the diverse needs of clients in the compliance process, weoffer adaptable support—whether providing standalone documents orcomprehensive technical assistance—ensuring swift project progress.

3. Reliable Quality Assurance
   Our advanced production base, with all products manufactured in Class100,000 cleanrooms, and a quality management system validated by numerousdomestic and international clients, provides a strong backbone forcompliance.

Why Choose Luminova’s Compliance Support?

• Focus on Production-Side Support:As a supplier, we offer professional documentation andtesting cooperation to streamline client registrations efficiently.

• Dependable Partnership:Wecollaborate seamlessly with clients and third-party organizations toensure a smooth compliance process.

• Global Capability:Whether forChina, the U.S., or the EU, we provide production support meeting relevantstandards.

As your CDMO partner, Luminova is more than a manufacturer—we are a trusted ally on your compliance journey. Through our professional production capabilities and technical support, we help your products overcome regulatory barriers and reach global markets swiftly. Let’s work together to achieve excellence in medical care!