Medical Device Regulatory Consulting Services
Cisema delivers specialized medical device consulting services for international clients looking to access the Chinese and Asia-Pacific markets. With a deep understanding of local regulations, we help medical device manufacturers navigate the full spectrum of regulatory compliance activities. Our bilingual consulting team, located across Europe and Asia, ensures timely, accurate, and fully compliant submission of all required regulatory documents.
Our services include registration, type testing, clinical research, post-market surveillance. Whether you're a digital health startup or a blue-chip in the medical device industry, Cisema offers hands-on support and strategic guidance tailored to your product type—covering devices, combination products, and more.
We go beyond medical device regulatory affairs. As one of the few consulting firms with cross-sector capabilities, we also serve related areas within the healthcare industry such as IVDs, pharmaceuticals, biopharma, cosmetics, health foods, veterinary medicines, and consumer goods. Our integrated approach allows clients to manage compliance across multiple verticals through one trusted partner.
Discover our China Medical Device Consulting Services
Whether you’re just starting out or are a blue-chip, access our wide range of services and solutions to help your business thrive in China.
China Medical Device Registration
We guide you through every step of the China medical device registration and filing process. We take care of compliance with NMPA requirements, advising you on the optimal market entry pathway, and helping you through the whole process
NMPA Legal Agent
We act as your official representative in China, handling registrations, filings, and ensuring you are fully compliant, including quality assurance and PMS requirements.
NMPA Type Testing
We provide end-to-end support for China type testing in NMPA-accredited laboratories. Our experienced test engineers offer on-site supervision to guarantee accurate and reliable results.
China Clinical Trials
You may be required to provide supplementary clinical data on Chinese patients or conduct a full clinical trial in China.Our clinical research consultants will advise you, prepare the study protocol and assist setting up the clinical trial in China.
NMPA Clinical Evaluation Report
CERs can avoid the need for a China clinical trial in some instances. Our experts can advise and prepare NMPA-compliant CERs.
Drug Device Combination Products
We assist with the classification, registration, and compliance of combination products in China, whether drug or device-led.
China Medical Device Quality Compliance
We help you achieve and ensure ongoing compliance with Chinese requirements.Our experts prepare and assist you for official NMPA inspections.
Medical Device PMS & Vigilance
The NMPA is placing greater focus on Post-Market Surveillance (PMS) such as more in-market sampling inspections and regular standard changes.Our specialist PMS team means you remain fully compliant at all tims.
Regulatory Outsourcing
Leverage our team of consultants and subject matter experts for specialized projects or long-term regulatory resource needs.
Our Hong Kong Medical Device Consulting Services
Our Hong Kong Medical Device 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.
Regulatory Outsourcing
If you are seeking specific specialist expertise or have ongoing resource-intensive needs, our team of consultants has a variety of solutions to meet your needs.
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Other Industries We Support
In addition to medical devices, we offer consulting services across regulated industries including IVDs, pharmaceuticals, biopharma, quasi-drugs, 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.
