Medical Device Registration: fast-track registration for medical devices relevant to containment of COVID-19

• On 7 February 2020, the National Medical Products Administration (NMPA) released a circular requiring expedited review and registration of protective clothing for medical use, requiring the NMPA and its local branches to adopt fast-track registration processes and grant registration certificates with a one year validity term. In response to the NMPA circular, local branches of the NMPA also released their local plans setting out the timeframe for the registration of urgently-needed medical supplies, such as face masks, protective clothing and COVID-19 diagnostic kits. In Guangdong Province, for example, the total timeframe for obtaining marketing authorization for urgently needed medical supplies was shortened to 10 days for medical devices and to 3 days for drugs. Based on the most updated statistics disclosed by the NMPA, as of 16 March, the NMPA has urgently approved 11 COVID-19 diagnostic reagents and 8 antibody detection reagents.
• In February and March 2020, we have seen local branches of the NMPA in many provinces in China, including Guangdong, Shanxi, Jiangxi, Guangxi and Anhui releasing local policies exempting medical devices companies from paying registration fees for the registration of medical devices urgently needed for the containment of COVID-19.

Price regulation on medical supplies

The State Administration for Market Regulation, the recently constituted super-regulator, which is, amongst other things, responsible for pricing regulation, issued opinions prohibiting business operations from “jacking up” prices (also known as “price gouging”) of COVID-19-related medical supplies, including face masks, disinfection products, protective clothing, anti-viral drugs and other medical products relating to the containment of COVID-19. To name but a few, the following activities can be deemed as "jacking up prices":

a) fabricating purchase costs;

b) spreading rumours about price hikes or using other language to mislead consumers into believing certain products are in serious short supply; and

c) imposing tie-in arrangements when selling epidemic prevention supplies.

"Jacking up prices" can lead to administrative penalties and even criminal liability if the amount of the unlawful gains is relatively large or there are other serious circumstances, and market order is seriously disrupted. As of 25 February 2020, Supreme People's Procuratorate statistics show that there have been 144 criminal cases of "jacking up prices" relating to COVID-19 related medical supplies and 236 people have been charged with the crime of unlawful business operations as a result.

Use of Internet-based medical services

During the COVID-19 outbreak, the National Health Commission (NHC) in China has promoted the widespread use of Internet-based medical services, so as to minimize population movements and reduce the risk of infection, and more importantly to relieve the excessive workload on the medical staff of the most heavily impacted areas. Although the use of internet tools to replace face-to-face contact is definitely being encouraged during these difficult times, unfortunately the regulatory landscape for telemedicine has not changed.

• The NHC is encouraging the bigger and better resourced hospitals, including the provincial-level designated hospitals for COVID-19, to provide remote consultation services for COVID-19 treatment to other hospitals in need. The NHC has appointed the National Telemedicine and Connected Health Center as the national remote consultation platform for the treatment of critically-ill patients infected with COVID-19. Designated COVID-19 hospitals can now make an application on the platform and specify their requirements for specialists. The platform will invite corresponding specialists to provide remote consultation services as well as their recommendations. In addition to remote consultation, the NHC is also encouraging hospitals to provide remote training and remote monitoring services to enhance the treatment skills of medical staff and to address patient care issues.
• The NHC is also recommending that qualified hospitals offer internet-based diagnostic services to patients to reduce the number of in-person visits to hospitals. Many hospitals have used their Internet platforms to provide free-of-charge online consultations, self-quarantine guidance and health assessment services relating to COVID-19. After the online consultation, information on suspected COVID-19 patients will be transferred to the designated COVID-19 hospital. For treatment of certain common or chronic diseases, the practice of return visits being carried out via Internet diagnostic services is also being encouraged to reduce unnecessary visits to hospitals.

Practical adjustments to accommodate clinical trials during COVID-19: "direct-to-patients" shipment of investigational drugs

As a general rule, under the Drug Good Clinical Practice (GCP) issued by the (now) NMPA effective 1 September 2003, clinical trial investigators must strictly control the supply and use of investigational drugs. Generally speaking, investigators must provide the investigational drugs to patients at study sites to ensure the dosage and use methodology are in line with the clinical trial protocol. However, people in China have been encouraged to stay at home and avoid unnecessary outdoor activities in order to reduce exposure to the COVID-19 virus. In particular, it was found that trial subjects were experiencing difficulty in accessing study sites (e.g. hospitals) due to the increased risk of infection from visiting the sites.

To accommodate the need to move forward with on-going drug clinical trials and to minimize exposure of patients to the virus, the China Forums of Clinical Research Capacity Building and Human Research Participants Protection (CCHRPP) recently issued the Consensus on Clinical Trial Management under the First-Level Response to Major Public Health Emergencies (CCHRPP Consensus) to provide guidance to on-going drug clinical trials currently being undertaken in China. This CCHRPP Consensus is not, strictly speaking, formal legislation, but more in the way of guidance to the relevant parties for their reference. Under the CCHRPP Consensus, investigational drugs can be directly delivered to patients by courier, provided that:

(a) the investigational drugs are suitable for delivery by courier – i.e., they are not delivered by injection, toxic, anesthetics or psychotropic drugs;
(b) the investigational drugs can only be couriered by qualified delivery companies that are able to transport the drugs under specific storage conditions; and
(c) drug management personnel in the clinical trial sites must keep records of all the drugs sent by courier, and contact patients to confirm receipt of the drugs as well as checking the storage status, temperature control and packaging of the drugs at the time of receipt.

Many hospitals in China have enacted their own GCP guidelines permitting "direct-to-patient" shipment services in response to COVID-19. However, as the COVID-19 epidemic is stabilizing in China and the intensity level of coronavirus emergency response processes is being gradually lowered in many cities, such direct-to-patients delivery policies may be subject to adjustments (e.g., some hospitals may start to cancel "direct-to-patient" delivery) if the situation in China continues to improve.

Conclusion

China has historically faced a large number of challenges in regulating its life sciences sector effectively. It has known more than its fair share of scandals and public health incidents, so it is understandable that it is cautious about relaxing standards. The COVID-19 pandemic has stretched its healthcare system to its limits. The common thread running through all of the above COVID-19 “adjustments,” is the strong dose of pragmatism that shines through, perhaps driven by the recognition that in parts of China, the number of patients is huge and resources limited. What this means is that important experimental drugs continue moving through the regulatory pipeline, medical devices that may provide front-line support to those fighting COVID-19 get approved expeditiously, and, by making smart use of telemedicine, hospitals don’t get overwhelmed by too many walk-ins.

The stakes are high as the costs of sticking doggedly to measures which were correct and appropriate in normal times are now measured in human lives, with the challenge always being the balance between pragmatism and relaxation of strict, long-standing safety protocols to make things work during these challenging, unprecedented times, and ensuring you do not expose the patients to another, perhaps greater danger. China may not have got everything right in dealing with COVID-19, but the epidemic does now seem to be under control there, and it is now able to relax some of the restrictions on movement, just as many other places around the world are tightening up their lockdown arrangements, so there are certainly valuable lessons to be learned from its approach for those jurisdictions where the number of cases is rising rapidly and which are already or will soon be facing the same issues.

Next steps

These policies may provide opportunities for market participants to continue working with their Chinese counterparties, albeit in different ways, or to bring their products to market in China. Please contact any of the listed contacts for further details on how we can help develop your business in China.

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