China
Definition of medical devices
Medical devices refer to instruments, equipment, appliances, in vitro diagnostic reagents and calibrators, materials, and other similar or related items used directly or indirectly on the human body, including the required computer software; their utility is mainly obtained through physical methods, etc. It is not obtained through pharmacology, immunology, or metabolism, or although these methods are involved but only play a supporting role; its purpose is:
- Diagnosis, prevention, monitoring, treatment, or alleviation of diseases,
- Diagnosis, monitoring, treatment, mitigation, or functional compensation of injury,
- Inspection, substitution, adjustment or support of physiological structure or physiological process,
- Life support or maintenance,
- Pregnancy control,
- Provide information for medical or diagnostic purposes by examining samples from the human body.
Classification
- Class I devices – Low risk: Medical devices that implements routine management which can ensure their safety and effectiveness.
- Class II medical device – Moderate risk: Medical devices that requires strict control and management to ensure their safety and effectiveness.
- Class III devices – High risk: Medical devices that requires special measures to strictly control and manage them to ensure their safety and effectiveness.
Competent Authorities and Registration Process
| Type of medical device | The Registration Pathway | Regulatory Authority | |
| Class I devices | Domestic medical devices | Filing documents | Municipal MPA |
| Import medical devices | NMPA | ||
| Class II medical device | Domestic medical devices | Registration | Provincial MPA |
| Import medical devices | NMPA | ||
| Class III devices | Registration | NMPA | |
Options for registration applicant
Our Services
Registration service
Registration service
With a team of experts deeply knowledgeable in local regulatory requirements and extensive hands-on experience in medical device registration, MedNovum is willing to accompanie enterprises through every step — from document preparation to achieving results — ensuring a registration process that is accurate, efficient, and timely.
Marketing Authorization Holder (MAH) Service
Marketing Authorization Holder (MAH) Service
If enterprises are concerned about the cost of establishing a legal entity in China or wish to avoid granting exclusive distribution rights to a local partner, MedNovum offers a flexible and optimal solution. Through our trusted partner based in China, we provide MAH service, supporting enterprises in submitting registration applications as designated, while helping them maintain control over product management and market.
Regulatory Compliance Consulting Service
Regulatory Compliance Consulting Service
-Language barriers and the complexity of local regulations often pose challenges for enterprises entering new markets. Don’t worry — with MedNovum’s specialized consulting services, we ensure your compliance from the initial market entry stage through post-market activities.
MEDNOVUM
YOUR COMPREHENSIVE PARTNER IN THE MEDICAL DEVICES SECTOR
HUMAN RESOURCES
MedNovum brings together a team of experienced experts, including lawyers, pharmacists, and engineers who are extensively trained in the field of medical devices. With a strong knowledge base and deep understanding of legal regulations, technical procedures, and market requirements across multiple countries, we are confident in delivering comprehensive, accurate, and effective service solutions to every client. The combination of legal expertise and technical proficiency is what sets MedNovum apart, making us a trusted partner for many years.
ISO CERTIFICATE
Achieving the ISO 9001:2015 certification is an important milestone in MedNovum’s development journey. This achievement shows our strong commitment to maintaining high-quality services, meeting customer expectations, and strengthening MedNovum’s position in the medical device market.
NUMBER OF YEARS OF EXPERIENCE
With over 10 years of experience in the medical device industry, we understand the needs and challenges that businesses face. MedNovum is committed to providing professional, accurate, and reliable services – helping our clients save time, ensure regulatory compliance, and improve business performance.