IVD Regulatory Consulting Services
Cisema offers specialized services for international in vitro diagnostic (IVD) manufacturers targeting the Chinese, Hong Kong, and ASEAN markets, including Malaysia, Vietnam, Singapore, Thailand, Indonesia, and the Philippines.
With deep knowledge of regional requirements and local authority expectations, our multi-lingual teams across Europe and Asia help you navigate complex regulatory pathways with confidence. Our experience enables us to expertly guide clients through the Asia-Pacific regional regulatory landscapes and leverage worldwide standards for market expansion.
Our services cover every stage of the regulatory process: from product classification, local type testing if required, and dossier preparation to NMPA registration in China, MDACS listings in Hong Kong, and regulatory submissions across ASEAN member states. We also support clinical trial exemptions, QMS documentation, labeling conformity, and post-market surveillance, ensuring a smooth market launch and ongoing compliance. Our in-house team and resources, including dedicated consultants and infrastructure, further strengthen our ability to support regulatory consulting and product development.
Whether you’re developing molecular diagnostics, immunoassays, or software-driven IVDs, Cisema delivers tailored support for your product type. We work with startups and multinational leaders alike, offering hands-on guidance and regulatory strategy insight throughout the registration process.
In addition to IVDs, our integrated services extend to related sectors such as medical devices, pharmaceuticals, health foods, cosmetics, and veterinary products, providing a single, reliable partner for your regulatory needs across the Asia-Pacific region. Clients have the opportunity to collaborate with Cisema for strategic guidance and feedback at every stage of the regulatory process, maximizing the potential for successful product development and regulatory approval. Our support is dedicated to ensuring the success of your product’s journey from development to market authorization.
Discover Our IVD Consulting Services
Whether you’re just starting out or are a blue-chip, access our wide range of solutions and valuable insights to help your business thrive in China and across Asia Pacific. We support clients with project-based regulatory consulting for specific product registrations or submissions, helping you navigate the regulatory challenges of market entry. Our team also emphasizes the importance of technology in IVD development and supports innovative technologies through the regulatory process.
NMPA IVD Approvals
We guide you through every step of the China IVD registration and filing process. We conduct thorough regulatory assessments to determine device classification and compliance requirements, ensuring you meet all NMPA standards.
NMPA Legal Agent
We are your authorized representative in China, and fulfill your NMPA registrations, filings and renewal applications as well as ensuring compliance with quality and PMS requirements.
China Clinical Trials
You may be required to provide supplementary clinical data on Chinese patients or conduct a full trial in China.Our clinical research team will advise you, prepare the study protocol and assist setting up the clinical trial in China.
China IVD Quality Compliance
We help you achieve and ensure ongoing quality assurance and compliance with Chinese requirements. We support you in managing risk and quality management systems to meet Chinese regulatory standards. Our experts prepare and assist you for official NMPA inspections.
Drug Device Combination Products
We assist with the classification, authorization, and compliance of combination products in China, whether drug or device led. We provide expert guidance for borderline products, addressing the complexity of their classification.
IVD PMS & Vigilance
The NMPA is placing greater focus on PMS such as more in-China sampling inspections and regular standard changes.Our specialist PMS team means you stay up to date with the many aspects of compliance.
IVD Regulatory Affairs Outsourcing
If you are seeking specific specialist expertise or have ongoing resource-intensive needs, we have a variety of solutions to meet your needs. We can support multiple projects simultaneously, ensuring efficient management and compliance.
Discover Our Hong Kong IVD Consulting Services
Our Hong Kong In-vitro Diagnostic Consulting Services provide targeted support to help you meet regulatory requirements and launch your products with confidence.
Hong Kong Local Responsible Person
We act as your designated Local Responsible Person (LRP), fulfilling listing and PMS obligations under MDACS.
Hong Kong IVD Registration
We support you through every stage of the Hong Kong IVD Listing process. From classification to handling regulatory requirements, we make the process as smooth as possible.
Discover Our Other IVD Consulting Services
Our local regulatory experts throughout ASEAN provide dedicated IVD Consulting Services to help you develop optimized regulatory strategies to meet requirements and confidently launch your products. We help clients implement best regulatory and quality practices, including good manufacturing practices and quality management practices, to ensure successful market entry in ASEAN countries:
Local Responsible Person
We act as your designated Local Responsible Person (LRP), fulfilling registration, post-market activities and QMS compliance. We also support clients with risk management processes, such as those aligned with ISO 14971, to meet ASEAN regulatory requirements.
IVD Market Approvals
We support you through every stage of the approval process. From classification to handling regulatory requirements, including risk management and adherence to best practices, we make the process as smooth as possible.
Other Markets We Support for Medical Device & IVD Registration
Cisema supports IVD and device registration, regulatory representation, and quality inspection services in:
Malaysia
Vietnam
Singapore
Thailand
Indonesia
Philippines
Taiwan
Other Industries We Support
In addition to IVDs, we offer consulting services across regulated industries including medical devices, pharmaceuticals, biopharma, cosmetics, health foods, veterinary products, and other industrial and consumer goods. Our team ensures tailored regulatory compliance strategies, regardless of product category or manufacturing model.
