China Medical Device Registration Services
Engaging with NMPA, SAMR, and NHC
Flexible regulatory terms, tailored regulatory intelligence, and local representation in China for seamless compliance and market access
OMC Medical China – Your Gateway to Regulatory Success
At OMC Medical, we are committed to supporting medical device manufacturers in navigating China’s complex regulatory landscape. With our expertise in NMPA registration, quality compliance, and market access, we ensure a smooth and efficient approval process for your products. Whether you need assistance with product classification, local representation, clinical evaluation, or post-market surveillance, our dedicated team in China is here to provide end-to-end regulatory solutions. Trust OMC Medical to help you achieve compliance and successfully enter the booming Chinese healthcare market
OMC Benefits
- Evaluation and classification of products as per NMPA regulations
- Registration of medical devices with NMPA, SMAR, and NHC
- Local representation in China (MAH/DMAH/Responsible Agent)
- Liaison with regulatory authorities, including NMPA, SMAR, and NHC
- Regulatory and market intelligence insights
- Management of regulatory queries and support
- Ongoing compliance monitoring and maintenance
- On-demand regulatory consultation services
Discover tailored solutions across pharmaceuticals, life sciences, consumer goods, and more. Our expertise spans diverse industries, ensuring compliance and excellence. Explore innovative strategies and services to elevate your business in the competitive market
China’s medical device and IVD market is highly regulated by the NMPA, requiring strict compliance for market approval. OMC Medical streamlines this process by offering expert support in product registration, supplier audits, QMS enhancement, process validation, and regulatory documentation. Our services ensure seamless market entry, sustained compliance, and a competitive edge in China’s evolving healthcare landscape
China’s cosmetics market is regulated by the NMPA, requiring strict compliance for product registration, safety assessments, and labeling. OMC Medical simplifies this process by providing expert guidance in regulatory approvals, in-country representation, supplier audits, and compliance maintenance. We help brands navigate China’s evolving cosmetic regulations, ensuring smooth market entry and long-term success
China’s pharmaceutical market is governed by strict NMPA regulations, requiring rigorous compliance for drug registration, clinical trials, quality control, and post-market surveillance. OMC Medical streamlines this process by offering expert support in regulatory approvals, in-country representation, GMP compliance, supplier audits, and documentation. We help pharmaceutical companies navigate China’s evolving regulatory landscape, ensuring smooth market entry and ongoing compliance
OMC Medical provides expert support for businesses seeking market entry in China by acting as an Authorized Representative and ensuring compliance with NMPA regulations. We assist with regulatory submissions, appointing a local Responsible Agent, and managing communications with Chinese authorities. Our expertise in China’s evolving regulatory landscape ensures a smooth approval process, enabling seamless market access for medical devices, pharmaceuticals, and cosmetics. With OMC Medical, you gain a trusted partner to navigate complex compliance requirements efficiently
OMC Medical provides expert translation services tailored to China’s regulatory landscape, ensuring compliance with NMPA requirements. As an ISO 17100:2015 certified provider, we specialize in accurate translations of medical, pharmaceutical, and clinical documents, including IFUs, user manuals, and legal texts. Our services help businesses navigate regulatory approvals and facilitate seamless market entry in China
About OMC
OMC Medical is a leading regulatory consulting firm specializing in global market access for medical devices, IVDs, pharmaceuticals, and cosmetics. With expertise in NMPA regulations, we assist businesses in navigating China’s complex compliance landscape, including product registration, quality assurance, in-country representation, and regulatory intelligence. Our tailored solutions ensure smooth approvals and seamless market entry, making OMC Medical a trusted partner for regulatory success
We are a global firm and we have local expertise across the following countries.
Europe
Asia
Africa
Oceania
South America
North America
- Location
Shanghai OMC Medical technology
Co, Room 701a, 7th Floor, No. 912 Gonghexin Road, Jing’an District, Shanghai
Have a Business Query? Let us Talk
Seamless Medical Device Registration in China – NMPA Compliance Made Easy
Expert Guidance for Medical Device Manufacturers | Fast-Track NMPA Approval | Guaranteed Compliance
Why Register with NMPA?
📈 A. Tap into China’s Booming Medical Device Market
- The China medical device market is expanding rapidly – don’t miss your opportunity to enter this high-growth sector
- Strict China medical device regulations make compliance challenging without expert guidance.
- Complex medical device registration in China can delay market entry
- Language barriers and China NMPA product registration challenges can slow down approvals.
OMC Medical Has You Covered
- Simplified Process & Faster Approval – Our team navigates the China medical device registration process with ease
- Expert Compliance Assistance – Get hassle-free regulatory support from specialists in China NMPA product registration
- Affordable Pricing & On-Time Delivery – Cost-effective solutions to help you enter the market quickly and efficiently
- Get a Free Consultation Today
Let OMC Medical handle your NMPA medical device registration while you focus on growing your business
Registration Steps
Product Classification & Testing
Submit Technical & Safety Documentation
NMPA Review & Approval Process
Receive Medical Device Registration Certificate
Product Registration
Authorized Representative
Testing
Product Classification
Technical Document
Quality Assurance
Clinical Trails
Joint Venture Programs
Why Choose OMC Medical?
- 15+ Years of Experience in China Medical Devices Regulatory
- 500+ Clients | 1000+ Successful Registrations
- Cost-Effective Solutions | Fast-Track Approvals
- Dedicated Compliance Team & Personalized Support
- All medical devices must comply with Chinese NMPA Regulatory Approval Process
- Labeling in Chinese is mandatory
- Post-Market Surveillance & Quality Control required
- OMC Medical ensures compliance with China Drug Policy & China Food and Drug Administration Standards
Frequently Asked Questions (FAQ)
It involves classification, local testing, clinical evaluation, and submission to NMPA. Approval time varies by class
- Class I: ~3 months
- Class II & III: 12-24 months (includes testing & clinical evaluation)
Manufacturers must submit technical documentation, risk analysis, and clinical data, ensuring compliance with NMPA regulations
All labels, IFUs, and product descriptions must be in Simplified Chinese and comply with NMPA standards
Yes, foreign manufacturers must appoint a local authorized representative for registration and compliance
Still Have Questions? Contact Us Now for a Free Consultation