CFDA Approved 7,530 Medical Devices in 2015, with 29 Products Entering the Innovative Medical Device Fast-Track Review

On April 1, the China Food and Drug Administration (CFDA) released the “2015 Annual Report on Medical Device Registration.” The report indicated that in 2015, the medical device registration work of the China Food and Drug Administration was mainly reflected in four major areas: improving the regulatory framework for medical device registration, advancing reforms in the review and approval system for medical devices, and strengthening the foundational infrastructure for registration.

Furthermore, in terms of the acceptance of medical device registration applications,In 2015, the China Food and Drug Administration (CFDA) accepted a total of 9,396 registration applications for medical devices (in vitro diagnostic reagents), including 2,402 initial registration applications, 5,105 renewal registration applications, and 1,889 applications for changes to licensed items. This represented a 6.7% year-on-year decrease compared to the corresponding registration acceptance figures in 2014.

In 2015, the China Food and Drug Administration (CFDA) approved a total of 7,530 medical device registrations. Among these, 2,707 were initial registrations, 4,072 were renewal registrations, and 751 were registrations for changes to licensed items. Compared with 2013 and 2014, the total number of approved registrations decreased slightly.

Meanwhile, the China Food and Drug Administration (CFDA) continued to conduct reviews of innovative medical devices in accordance with the Special Approval Procedures for Innovative Medical Devices (Trial), and approved the market launch of certain innovative medical device products.

Among the numerous approved projects, there are also products from internet healthcare companies. If your project is among those certified by the CFDA and you wish to have it covered by VCBeat, please send your project materials to tg@vcbeat.top.

Below is the original report:

In 2015, the China Food and Drug Administration (hereinafter referred to as the CFDA), committed to safeguarding and promoting public health, thoroughly implemented the Regulations on the Supervision and Administration of Medical Devices (State Council Decree No. 650) and the Opinions of the State Council on Reforming the Review and Approval System for Drugs and Medical Devices (Guo Fa [2015] No. 44). The CFDA advanced reforms in the medical device review and approval system, standardized and guided medical device registration work across China, and enhanced the quality and efficiency of medical device registration reviews.

I. Status of Medical Device Registration

In accordance with the Regulations on the Supervision and Administration of Medical Devices, the China Food and Drug Administration is responsible for the acceptance, technical review, and administrative approval of registration applications for Class III medical devices manufactured in China, as well as for imported Class II and Class III medical devices. Provincial-level food and drug administration departments are responsible for the acceptance, technical review, and administrative approval of registration applications for Class II medical devices manufactured in China.

(I) Improving the Regulatory Framework for Medical Device Registration

Formulated and released“Rules for the Classification of Medical Devices,” “Rules for the Naming of Generic Names of Medical Devices,” “Technical Guidelines for Clinical Evaluation of Medical Devices,” “Procedures for Verification of Quality Management Systems for Registration of Class III Medical Devices Manufactured Domestically,” and other 16 regulations and normative documentsThe regulatory framework for medical device registration has been further improved, standardizing technical review, registration inspection, and other related activities. This provides a solid regulatory foundation for the orderly conduct of registration management by food and drug regulatory authorities at all levels, as well as for the submission of registration applications by regulated entities.

(II) Advancing the Reform of the Review and Approval System for Medical Devices

In 2015, the Center for Medical Device Evaluation of the China Food and Drug Administration researched and formulated an implementation plan for reforming the evaluation mechanism, further strengthening pre-service training and continuing education for evaluators to enhance their overall professional competence.

The China Food and Drug Administration reviewed and issued 28 national standards, including “Active Implantable Medical Devices,” and 90 industry standards, including “Water for Hemodialysis and Related Therapies.” It formulated the “Work Plan for Reform of Classification Management of Medical Devices,” established the Medical Device Classification Technical Committee, and initiated the revision of the “Medical Device Classification Catalog.”Continue to carry out the review of innovative medical devices in accordance with the Special Approval Procedures for Innovative Medical Devices (Trial), and promote the innovative development of the medical device industry.

(3) Conduct assessment and evaluation of provincial-level medical device review and approval capabilities

The China Food and Drug Administration issued the "Guiding Opinions on Strengthening the Construction of Provincial Medical Device Technical Review Capabilities," organized the formulation of the "Work Plan for Assessment and Evaluation of Provincial Medical Device Review and Approval Capabilities," and carried out pilot assessments of provincial medical device review and approval capabilities, thereby promoting the improvement of the level and quality of registration management by provincial food and drug regulatory authorities.

(4) Strengthening the Foundation of Registration Work

The China Food and Drug Administration continues to advance the development and revision of technical review guidelines for medical device registration.A total of 12 technical review guidelines for product registration, including the “Guideline for Hepatitis B Virus Genotyping Reagents,” and two guideline documents for instruction manual preparation, including the “Guideline for Soft Hydrophilic Contact Lenses,” were issued. By the end of 2015, a total of 125 technical review guidelines for medical device registration had been released.The issuance of the guidelines further standardizes the criteria for the registration of specific medical devices across China, providing effective guidance to regulated entities in preparing and submitting their registration applications.

On December 20, 2015, the new medical device registration management system of the China Food and Drug Administration was launched and put into use., standardize the requirements for electronic registration submissions, and enhance the level of informatization and work efficiency in the review process.

II. Acceptance Status of Medical Device Registration Applications

In 2015, the China Food and Drug Administration (CFDA) accepted a total of 9,396 registration applications for medical devices (in vitro diagnostic reagents), including 2,402 initial registration applications, 5,105 renewal registration applications, and 1,889 applications for changes to licensed items, representing a 6.7% year-on-year decrease compared to 2014.

(I) Overall Situation

In 2015, 3,921 applications for registration of domestic Class III medical devices (in vitro diagnostic reagents) and 5,475 applications for registration of imported medical devices (in vitro diagnostic reagents) were accepted.

By registered product category, there were 5,509 medical device registration applications and 3,887 in vitro diagnostic reagent registration applications.

By registration type, there were 2,402 applications for initial registration, 5,105 applications for renewal of registration, and 1,889 applications for changes to licensed items.

Figure 1. Proportion of Registration Types

(II) Itemized Details

1. Acceptance of Registration Applications for Class III Medical Devices in China

In 2015, a total of 3,921 applications for registration of Class III medical devices were accepted in China. Among these, there were 2,219 applications for medical device registration and 1,702 applications for in vitro diagnostic (IVD) reagent registration.

In terms of registration type, there were 1,562 applications for initial registration, accounting for 40%; 1,635 applications for renewal registration, accounting for 42%; and 724 applications for registration of changes to licensed items, accounting for 18%.

2. Acceptance Status of Registration Applications for Imported Class II Medical Devices

In 2015, a total of 3,024 applications for the registration of imported Class II medical devices were accepted. Among these, there were 1,339 applications for medical device registration and 1,685 applications for in vitro diagnostic reagent registration.

In terms of registration type, initial registration applications accounted for 499 items (17%); renewal registration applications accounted for 1,895 items (63%); and registration applications for changes in licensed items accounted for 20%.

3. Acceptance of Registration Applications for Imported Class III Medical Devices

In 2015, a total of 2,451 applications for the registration of imported Class III medical devices were accepted. Among these, 1,951 were applications for medical device registration, and 500 were applications for in vitro diagnostic (IVD) reagent registration.

In terms of registration type, there were 341 applications for initial registration, accounting for 14%; 1,575 applications for renewal registration, accounting for 64%; and 535 applications for registration of changes to licensed items, accounting for 22%.

Figure 2. Distribution of Registration Formats for Domestic Class III, Imported Class II, and Imported Class III Medical Devices

In summary, apart from domestic Class III in vitro diagnostic (IVD) reagents, where the number of initial registration applications exceeded that of renewal registrations, the number of renewal registration applications for domestic Class III medical devices, imported medical devices, and IVD reagents all surpassed their respective initial registration application counts. Furthermore, regardless of whether they were domestic Class III or imported medical devices, the proportion of registration applications for changes to licensed items was roughly equivalent, accounting for approximately 20% in both cases.

III. Review and Approval Status of Medical Device Registrations

(I) Overall Situation

In 2015, the China Food and Drug Administration (CFDA) approved a total of 7,530 medical device registrations. Among these, 2,707 were initial registrations, 4,072 were renewal registrations, and 751 were registrations for changes to licensed items. Compared with 2013 and 2014, the total number of approved registrations decreased slightly.

In 2015, the China Food and Drug Administration denied registration for a total of 1,297 medical device registration applications.

Figure 3. Registration Data Chart for 2013–2015

Among these, there were 2,730 registrations for Class III medical devices (including in vitro diagnostic reagents) manufactured in China, and 4,800 registrations for imported Class II and Class III medical devices (including in vitro diagnostic reagents).

Figure 4. Registration Data of Domestically Produced and Imported Medical Devices in 2015

Categorized by registration type, there were 4,823 medical device items and 2,707 in vitro diagnostic (IVD) reagent items, with a ratio of approximately 6:4. Categorized by registration form, the specific distribution is shown in the figure below.

Figure 5. Proportion Chart of Registration Forms

(II) Itemized Statistics

1. Domestic Class III Medical Devices (In Vitro Diagnostic Reagents)

There were 334 initial registrations, 1,074 renewal registrations, and 86 registrations for changes to licensed items for Class III medical devices manufactured in China.

514 initial registrations, 479 renewal registrations, and 243 changes to licensed items for Class III in vitro diagnostic reagents within China.

Figure 6. Proportion of Registration Types for Domestic Class III Medical Devices and In Vitro Diagnostic Reagents

2. Imported Medical Devices (In Vitro Diagnostic Reagents)

1,533 items for initial registration of imported medical devices, 1,640 items for renewal registration, and 156 items for registration of changes in licensing matters.

326 items for initial registration, 879 items for renewal registration, and 266 items for registration of changes to licensed matters of imported in vitro diagnostic reagents.

Figure 7. Proportion of Registration Types for Imported Medical Devices and In Vitro Diagnostic Reagents

In summary, from the overall perspective of approved products, the number of approvals for registration renewals exceeds that of initial registrations; however, for domestic Class III in vitro diagnostic reagents, the number of initial registrations exceeds that of registration renewals.

3. Analysis of Specifically Approved Product Categories

Data from initial and renewal registrations show that in vitro diagnostic reagents hold a significant advantage in terms of product proportion within the corresponding registration categories.

Among domestically produced Class III medical devices, in vitro diagnostic (IVD) reagents accounted for 45% of all registrations; among imported medical devices, IVD reagents comprised 31%.

In 2015, registered domestic Class III medical devices, excluding in vitro diagnostic reagents, involved products from 26 subcategories of the Medical Device Classification Catalog.

The top five domestically registered Class III medical devices are: medical polymer materials and products, implantable materials and artificial organs, injection and puncture instruments, medical optical instruments, equipment, and endoscopic devices, and interventional devices.

Figure 8. Ranking of Registered Class III Medical Devices in China

In 2015, registered imported medical devices, excluding in vitro diagnostic reagents, covered products from 41 subcategories of the "Medical Device Classification Catalog."

The top five categories of imported medical devices by registration volume are primarily: medical optical instruments, apparatuses, and endoscopic equipment; implantable materials and artificial organs; dental materials; medical electronic instruments and equipment; and medical polymer materials and products.

Figure 9. Ranking of Registered Imported Medical Device Varieties

4. Country Analysis of Imported Medical Devices

In 2015, medical devices from the United States, Germany, Japan, the United Kingdom, and South Korea ranked in the top five for the number of registrations in China, accounting for approximately 67% of the total number of initial and renewal registrations for imported products that year.

Figure 10. Ranking of Imported Medical Devices by Country of Registration

5. Provincial Analysis of Class III Medical Devices in China

An analysis of the registration status of domestic Class III medical devices in 2015 reveals that manufacturers of these registered products are primarily concentrated in the economically developed coastal provinces.

Figure 11. Distribution of Provincial Registrations for Domestic Class III Medical Devices

Among them, Beijing, Jiangsu, Guangdong, Shanghai, and Shandong are the provinces with the highest number of Class III medical device registrations in China, accounting for 67% of the total number of initial and renewal registrations for domestic Class III medical devices in 2015.

Figure 12. Ranking of Provinces for Registration of Class III Medical Devices in China

IV. Review and Approval Status of Innovative Medical Devices and Other Products

In 2015, the China Food and Drug Administration (CFDA) continued to conduct reviews of innovative medical devices in accordance with the Special Approval Procedures for Innovative Medical Devices (Trial), and approved the market launch of certain innovative medical device products.

In 2015, the China Food and Drug Administration (CFDA) received a total of 157 applications for special examination and approval of innovative medical devices, and completed the review of 166 applications (including those submitted in 2014). As a result of the review, 29 products were determined eligible for the special examination and approval pathway for innovative medical devices. Market approval was granted for nine products, including acellular corneal stroma. Among these approved products, five were active medical devices, three were in vitro diagnostic reagents, and one was a passive medical device.

These innovative products are protected by Chinese invention patents, or their invention patent applications have been published by the patent administration department under the State Council. Their core working principles/mechanisms of action are first-of-their-kind in China, demonstrating significant clinical application value.

(1) Isothermal Amplification Microfluidic Chip Nucleic Acid Analyzer (NMPA Registration No. 20153400580, CapitalBio Corporation). This instrument integrates microfluidic chip technology with isothermal amplification technology, enabling high-throughput parallel detection of multiple nucleic acid target sequences simultaneously. When used in conjunction with its accompanying in vitro diagnostic reagents, it is intended for the detection of nucleic acids (DNA) in human biological samples.

(2) Acellular corneal stroma (NMPA Registration No. 20153460581, Shenzhen Ainier Corneal Engineering Co., Ltd.). It is indicated for the treatment of non-perforated corneal ulcers refractory to medical therapy and for temporary coverage of corneal perforations. As China’s first artificial cornea product, it provides a new therapeutic option for patients with corneal ulcers.

(3) Dual-channel implantable deep brain stimulation pulse generator kits, implantable deep brain stimulation lead kits, and implantable deep brain stimulation extension lead kits (NMPA Registration No. 20153210970, NMPA Registration No. 20153210971, NMPA Registration No. 20153210972; Suzhou Jingyu Medical Device Co., Ltd.). When used in combination, the aforementioned products deliver stimulation to the subthalamic nucleus (STN) for the treatment of patients with advanced primary Parkinson’s disease whose motor dysfunction symptoms are not adequately controlled by medication.

(4) MTHFR C677T Gene Detection Kit (PCR-Gold Magnetic Particle Chromatography) (NMPA Registration No. 20153401148, Xi'an JinCi Nano Biotechnology Co., Ltd.). This kit is used for the qualitative detection of the methylenetetrahydrofolate reductase (MTHFR) C677T genotype in genomic DNA extracted from human peripheral blood. It enables rapid and convenient genotyping of the target gene locus, providing additional tools for the auxiliary diagnosis of patients with elevated homocysteine levels or folate metabolism abnormalities.

(5) Septin9 Gene Methylation Detection Kit (PCR Fluorescent Probe Method). (NMPA Registration No. 20153401481, Boercheng (Beijing) Technology Co., Ltd.) Used for the qualitative in vitro detection of Septin9 gene methylation in human peripheral blood plasma, providing patients with a non-invasive option for the auxiliary diagnosis of colorectal cancer.

(6) Digital Breast Tomosynthesis Equipment (NMPA Registration No. 20153302052, Koning (Tianjin) Medical Equipment Co., Ltd.). Used for the diagnosis and differential diagnosis of breast diseases. It is the first true three-dimensional breast imaging system in China, addressing the issue of overlapping breast tissue in mammography. It can acquire CT tomographic images of the breast without compression, with isotropic spatial resolution across all three axes. This enables better detection and characterization of calcification clusters and their three-dimensional distribution, and can also be used to assess tumor angiogenesis.

(7) Survival Motor Neuron 1 (SMN1) Gene Exon Deletion Detection Kit (Quantitative Fluorescent PCR Method) (National Medical Device Registration No. 20153402293, Shanghai Wuse Shi Medical Research Co., Ltd.). This product employs multiplex real-time fluorescent MGB-TaqMan probe PCR to perform relative quantification of the copy numbers of exon 7 and exon 8 of the SMN1 gene, for use in the in vitro auxiliary molecular diagnosis of patients with spinal muscular atrophy (SMA).

In 2015, the China Food and Drug Administration also approved the registration of certain medical device products with promising clinical application prospects, such as:

(1) Particle therapy equipment (National Medical Device Registration No. 20153320876, Siemens AG), the first proton/carbon ion therapy system approved by the China Food and Drug Administration in 2015, is used for the treatment of solid malignant tumors throughout the body and certain benign diseases.

(2) Positron Emission Magnetic Resonance Imaging Systems (China NMPA Import Registration No. 20153282530, Siemens AG; and China NMPA Import Registration No. 20153333982, GE Medical Systems, LLC), which integrate magnetic resonance diagnostic equipment with positron emission tomography scanning systems, enabling the simultaneous and isocentric acquisition of physiological and anatomical information.

(3) Left atrial appendage occluder (NMPA Import Registration No. 20153773158, St. Jude Medical Coordination Center BVBA) is an implantable device developed in recent years for the percutaneous interventional treatment of cardioembolic stroke in patients with non-valvular atrial fibrillation. Following the approval by the China Food and Drug Administration (CFDA) of a corresponding product from Boston Scientific Ireland Limited in 2013, another product was approved in 2015, making it a current focus of research and development among manufacturers.

(4) Ultra-High Performance Liquid Chromatography-Tandem Mass Spectrometry (UHPLC-MS/MS) System and Reagents (NMPA Import Registration No. 20152400515, NMPA Import Registration No. 20152401820; Waters Corporation). This product is primarily used to analyze a variety of compounds, including diagnostic markers and therapeutic monitoring compounds. For the monitoring of certain novel therapeutic drugs, the system enables the direct establishment of detection methods and offers greater precision in trace-level analysis compared to existing methods.

(5) Reagents for the detection of certain novel pathogens, such as the Human Rhinovirus Nucleic Acid Detection Kit (PCR-Fluorescent Probe Method) and the Human Bocavirus Nucleic Acid Detection Kit (PCR-Fluorescent Probe Method) (NMPA Registration No. 20153400295 and NMPA Registration No. 20153400294, Hubei Langde Medical Technology Co., Ltd.), have provided effective tools for the clinical diagnosis of infections caused by relevant pathogens.

In 2015, with regard to the review of emergency medical device products, the China Food and Drug Administration (CFDA), in accordance with the requirements of the "Procedures for Emergency Approval of Medical Devices" and following expert evaluation, approved five manufacturers' Middle East Respiratory Syndrome Coronavirus (MERS-CoV) detection reagents for entry into the emergency approval process. Building on the approval of three emergency Ebola virus detection reagents in 2014, the CFDA approved two additional Ebola virus detection reagents in 2015: the Ebola Virus (Zaire strain) Nucleic Acid Detection Kit (PCR-Fluorescent Probe Method) (National Medical Device Registration No. 20153400327, BGI BioMed (Wuhan) Co., Ltd.) and the Ebola Virus (Zaire strain) Nucleic Acid Detection Kit (PCR-Fluorescent Probe Method) (National Medical Device Registration No. 20153400224, Suzhou Tianlong Biotechnology Co., Ltd.).

V. Other Information

(I) Registration Status of Domestic Class II Medical Devices

In 2015, provincial-level food and drug regulatory authorities across China approved a total of 12,284 registrations for domestically produced Class II medical devices. Among these, 5,566 were initial registrations, 4,918 were renewals, and 1,800 were registrations for changes to licensed items.

Figure 13. Proportion of Registration Types for Class II Medical Devices in China

Provincial Breakdown:

Figure 14. Provincial Registration Data for Class II Medical Devices in China

Based on registration data from provincial-level food and drug regulatory authorities, Guangdong, Jiangsu, Beijing, Zhejiang, Shanghai, Shandong, and Henan (seven provinces/municipalities) have registered a relatively large number of domestic Class II medical devices.

(II) Filing Status of Class I Medical Devices

In 2015, the China Food and Drug Administration (CFDA) processed a total of 2,488 filings for imported Class I medical devices in accordance with its responsibilities.

China's municipal-level food and drug regulatory authorities in districts and cities processed a total of 13,516 domestic Class I medical device filings in accordance with their responsibilities.

(III) Changes in Registration Matters

In 2015, the China Food and Drug Administration (CFDA), in accordance with its responsibilities, processed a total of 4,691 changes to registration particulars for imported Class II and Class III medical devices and domestically produced Class III medical devices. Among these, 1,590 changes pertained to domestically produced Class III medical devices, and 3,101 changes pertained to imported Class II and Class III medical devices.

Across China, provincial-level food and drug regulatory authorities collectively processed 5,255 changes to registration particulars for domestically produced Class II medical devices in accordance with their respective responsibilities.