CHINA Law and Practice Contributed by: Alan Zhou, Coco Fan, Kelly Cao and Stephanie Wang, Global Law Office
HGR upon filing/approval by the HGR authority and are strictly prohibited from collecting or stor- ing Chinese HGR in the PRC and transferring the Chinese HGR overseas. Failure to obtain the filing/approval may result in administrative liabili- ties or even criminal liabilities. The Implementa- tion Rules on the HGR Regulation provide spe- cific guidance on determining foreign parties and a more specific scope of HGR, excluding clinical data, imaging data, protein data and metabolic data from the scope of the HGR Regulation. 2.6 Databases Containing Personal or Sensitive Data In addition to the statutory requirements set out in 2.5 Use of Data Resulting From Clini- cal Trials , the Guidelines for Clinical Trial Data Management issued by the NMPA set out the basic standards for the responsibility, qualifica- tion and training of parties responsible for data management, and requirements for the design of data management systems, the standardisa- tion of clinical trial data, quality control and the assessment of clinical data. 3. Marketing Authorisations for Pharmaceuticals or Medical Devices 3.1 Product Classification: Pharmaceuticals or Medical Devices The DAL defines “drug” as a substance used to prevent, treat or diagnose human diseases and intended to regulate human physiological func- tions, for which usage and dosage are speci- fied for indication/primary treatment. The list of types of drugs includes traditional Chinese medicines, chemical drugs and biological prod- ucts. The CDE evaluates drug marketing authori- sation applications submitted by manufacturers or development institutions.
The term “medical devices” refers to instru - ments, equipment, appliances, IVD reagents and calibrators, materials and other similar or related articles (including computer software) that can be used directly or indirectly with human bodies to achieve specified purposes (such as diag- nosis, prevention and monitoring) and whose effectiveness is primarily achieved by physical or other similar means rather than by pharma- cological, immunological or metabolic means (or under circumstances where these latter means only serve auxiliary functions). The Center for Medical Device Evaluation (the “CMDE” ) of the NMPA is responsible for the tech- nical evaluation of medical devices. The NMPA has released the Announcement on Standard- ising the Identification of the Classification of Medical Device Products, outlining procedures to apply for the classification of newly developed medical devices which have never been classi- fied before or where provincial MPA finds it hard to identify the device. The NMPA has issued and been constantly updating the Medical Device Classification Catalogue, indicating its commit- ment to maintaining the regulatory environment with the rapid development of medical device technologies and the industry. The following applies to products containing both a drug and a device (ie, a combination product). • Applicants should apply for its registration as a drug if the product mainly acts as a drug, and as a medical device if the product mainly acts as a medical device. • If the major utility of a combination product cannot be easily identified, the applicant will apply for the product attribute identification with the NMPA and submit a registration application accordingly.
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