Current Regulatory Process and Reform
Companies interested in entering the Chinese market for innovative medical devices and treatments must first overcome existing barriers to market access and navigate an uncertain and changing regulatory environment. The “Management Standard for Technical Review and Consulting for Medical Devices,” (Management Standard) released in October 2016 has essentially closed the existing channel for pre-submission consultation prior to submission of product registration documents. The medical device industry is concerned that this will delay the overall registration process.
In May 2015, The CFDA issued the “Technical Guidelines for Clinical Evaluation of Medical Devices” (Technical Guidelines); requiring medical device producers to provide comprehensive evaluations of clinical effectiveness and product safety based on equivalent devices already on the market. This is especially burdensome for new and innovative products seeking market access as quickly as possible.
The Implementation of “Good Clinical Practices for Medical Devices” in June 2016 has created a number of challenges for foreign companies regarding clinical trials. In addition, many of China’s medical device standards are not in compliance with related international standards. This may cause difficulties and delays in bringing an existing product into the Chinese market.
Significant progress to improve market access for U.S. medical device manufacturers was made at the 2016 U.S.-China Joint Commission on Commerce and Trade (JCCT) on Medical Devices. Chinese commitments include: strengthening oversight on government procurement of medical devices and to treat overseas brands and products manufactured overseas in a transparent, fair and equitable manner, such that both sides stand ready to further communicate with parties concerned.
China has issued two batches of Class II Medical Device Clinical Trial Exemption Catalogues and Class III Medical Device Clinical Trial Exemption Catalogues. China will consider and evaluate opinions from industry and relevant stakeholders as it continues to develop and work in this area.
China will adjust its medical device classification system based on commonly recognized and risk-based principles, appropriately downgrading device classes. Industry comments will also be solicited.
During the drafting of China’s identification number regulations and implementing plans, it will fully consider relying on international standards to harmonize more with globally accredited unique device identification (UDI) issuing agencies. China will also offer a phased-in and risk-based implementation approach, a transitional period, and an exemption for all devices manufactured or labeled prior to the rule’s effective date.
The best-selling prospects in the medical device sector include:
In vitro diagnostic equipment and reagents: clinical and diagnostic analysis equipment, diagnostic reagents, medical test and basic equipment instruments, and point of care testing (POCT).
Implantable and intervention materials and artificial organs: Interventional materials, implantable artificial organs, contact artificial organs, stent, implantable materials, and artificial organ assisting equipment.
Therapeutic products: Tri-dimensional ultrasonic-focused therapeutic systems, body rotary gamma knife, simulator, linear accelerator, laser diagnostic and surgical equipment, nuclide treatment equipment, physical and rehabilitation equipment.
Medical diagnostic and imaging equipment: black & white and colored supersonic diagnostic units, sleeping monitor, digital X-ray system, MRI, CT, DR, and ultrasound equipment.
Surgical and emergency appliances: anesthesia ventilation systems and components: high frequency surgical equipment, high frequency and voltage generators.
Healthcare Information Technology related equipment and products: medical software, computer-aided diagnostic equipment, and hospital information systems (HIS, CIS, and HLT).
Medical equipment parts and accessories.
Source: published government and other data.