Market Access (Regulatory & Clinical) in China and Hong Kong SAR

What we can do?

By setting up RA and clinical teams in China mainland and Hong Kong SAR, we are able to cover the regulatory affairs services in both regions for medical device, in-vitro diagnostics and pharmaceuticals. With both device and pharma teams, JMedTec is specially strong in drug-device combinations.

Our Regulatory Services in China

Medical devices are regulated in three classes in China. The class I device requires for a notification without technical review, whereas the class II and class III devices require a long-time process of registration.

The same like medical devices, in-vitro diagnostics (IVD) are regulated in three classes. The class I IVD requires for a notification without technical review, whereas the class II and class III IVDs require a long-time process of registration.

The current regulations of drug-device combination products are issued before the year of 2010. The NMPA is working at new regulations of this topics. 

Currently, drug-device combinations are of two categories:

  • Device incorporating a medicinal substance, the review process of which is led by the Center for Medical Device Evaluation (CMDE)
  • Medicinal product with device components, the review process of which is led by the Center for Drug Evaluation (CDE)

JMedTec has expert consultant as the member in the Work Group for DDC new regulation establishment and can update you the information about DDC approval.

We cover:

Marketing approval for new-new drugs in China

Marketing approval for ANDA in China

OTC Switch in China

Market Access in China

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Herbal medicine is considered as one type of Chinese traditional medicine. The registration process may involve the clinical trial in China.

Our Regulatory Services in Hong Kong SAR

Medical devices are regulated in four classes in Hong Kong SAR. 

  • Medical devices listing in Hong Kong SAR
  • Local Responsible Person of Medical Devices in Hong Kong SAR

Like medical devices, in-vitro diagnostics are regulated in four classes in Hong Kong SAR. 

  • IVD listing in Hong Kong SAR
  • Local Responsible Person of IVDs in Hong Kong SAR

Clinical Trials in China

J MedTec provides companies worldwide with clinical trial services that comply with ethical and scientific principles, as well as the requirements of the China NMPA (ex-CFDA).

JMedTec provides full services as a CRO, including project management, protocol design, trial monitoring, data management, statistical analysis, and report writing. We are able to coordinate effectively sites, investigators, laboratories, and communicate efficiently with the authorities. We can optimize the work flow to ensure the fast, high quality, convenient and low-risk services for the clients. 
 
We are especially strong in the fields of
    • Neurology
    • Cardiovascular
    • Anesthesia
    • Ophthalmology
    • Gynecology
    • Oncology
    • IVD
    • Drug and Device Combinations  

Medical Writing

Medical writing for medical technology industry requires an good understanding of the medical concepts and terminology, experiences in research and science, knowledge of regulations and guidelines, and excellent good writing skills. Professional medical writers would be able to form the documentation with the best usage of data in the full compliance of regulations, thus facilitate the registration process.

JMedTec medical team includes highly experienced writers who can deliver work in both English and Chinese in the regulation frame of China NMPA (ex-CFDA), European CE marking and US FDA. Some clinical evaluation reports composed by our team have been used by NMPA reviewers as model essays.

Our services in medical writing include:

  • Clinical evaluation report for China NMPA registration, European CE marking and/or US FDA approval
  • Chinese <-> English Medical Translation