Clinical & Regulatory

Clinical & Regulatory

China: manufacturers under further obligations



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The NMPA – as CFDA’s succeeding governing body responsible for ensuring public health through monitoring the safety of medical devices – is reorganising itself. Among other things, efforts in the area of quality management are being intensified. Anna Fischer, a business consultant at Cisema (Hong Kong) Limited, which provides comprehensive support to companies for the registration of medical devices and regulatory affairs in China, weighs up the consequences

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According to Made in China 2025, the People’s Republic intends to become a high-tech producer and to achieve market leadership in ten key sectors. These include biopharmaceuticals and medical technology, which fall within the scope of the newly established NMPA (National Medical Products Administration) – formerly known as CFDA (China Food and Drug Administration). This development is also described by the Chinese state leadership with the term ‘new normality’. From a Chinese perspective, it’s normal and desirable for companies from China to assume the role of both an economic partner and a competitor for the Western pharmaceutical and medical technology industries. China’s pharmaceutical and medical technology companies are becoming strong competitors against foreign manufacturers.

During the People’s Congress in 2018, a reduction of ministries and head offices/central administrations from 34 to 26 was announced.  Since the announcement, the newly founded SAMR (State Administration for Market Regulation) has been active in partaking in the streamlining measures adopted by the Chinese government. The SAMR oversees the operations of the SAIC (State Administration of Industry and Commerce), the AQSIQ (General Administration of Quality Supervision, Inspection and Quarantine), the CFDA (China Food and Drug Administration), the NDRC (The National Development and Reform Commission) and the Office of the State Council of the Anti-Monopoly Committee. It also plans to integrate the responsibilities of the SAC (Standardization and Standardization Authorities), CNCA (Certification and Accreditation) and the SIPO (State Patent Office).

NMPA’s new range of responsibilities

The NMPA is subordinate to the SAMR in the Chinese administrative apparatus. It officially replaced the CFDA on 1 September 2018. Contrary to what the name suggests, the NMPA is not only responsible for medical devices, but also for in-vitro diagnostics, pharmaceuticals, and cosmetics. In doing so, the agency assumes the role of the CFDA when it pertains to ensuring public health through safe and effective products.

Within the SAMR, the CFDA was not only renamed NMPA but also re-tailored with regards to its responsibility spectrum. The former areas of the CFDA are not completely transferred to the area of ​​duty of the NMPA. Health Food, Infant Formula and Food for Specialty Medical Purpose will officially be removed from the NMPA’s range of tasks in the near future. The aim of the restructuring is also to clarify the responsibilities for market surveillance and import and export control. The duties of import and export inspection and quarantine are now assigned to the GAC (General Administration of Customs). The GAC also takes over the monitoring of foods, such as dairy, meat, seafood and ‘bird nests’ from the former CFDA.

Companies need to nominate a NMPA Legal Agent

NMPA, the successor to CFDA, is the single regulatory body responsible for registering medical devices including in vitro diagnostics, pharmaceuticals, and cosmetics in China. For this, the NMPA demands comprehensive documentation from all its applicants. Foreign applicants have to submit the documents in both, English and Chinese. Documents that have been prepared in China, such as test reports on electromagnetic compatibility, electrical safety or biocompatibility, must be presented in Chinese only. This also applies to CERs (Clinical Evaluation Reports), which are necessary for imported Class II and Class III medical devices. These assessments are based on data collected in clinical studies abroad or in China. The clinical data of a ‘predicate device’, ie an equivalent product, which already has been approved in China, can also be used for the CER.

Submission of application documents, however, can only be done by a China-based legal entity, the NMPA Legal Agent. Foreign manufacturers have the option to nominate their own subsidiary, distributor, or neutral consultant for the activity of the NMPA Legal Agent. The NMPA Legal Agent is the only official interface to NMPA, and receives the original documents and thus the authority to import the approved products at the end of the registration process.

In addition to approval, NMPA is also responsible for the safety of medical devices, in-vitro diagnostics, pharmaceuticals and cosmetics. This involves the formulation of safety standards, monitoring and management guidelines, drafting of legislation and regulations, as well as the supervision of their implementation. China generally insists on compliance with national standards. Typically, these are identical or equivalent to the respective international standards. As in the case of all other Chinese mandatory certifications, the NMPA does not accept tests based on international standards, such as an IEC standard for testing electromagnetic compatibility or electrical safety. The authorities strictly adhere to national provisions, ie GB (Guo Biao) standards – the national mandatory standards – or YY standards, which represent the mandatory industrial standards for medical devices.

At the international level, the NMPA is responsible for the development of international regulatory conditions and standards, as well as for cooperation with international monitoring and administrative organizations of medicinal devices, pharmaceuticals and cosmetics. The authority is also responsible for the registration management of medical devices, in-vitro diagnostics, pharmaceuticals and cosmetics. In these points, the NMPA hardly differs from its predecessor, the CFDA. On the other hand, its efforts in the field of quality management are to be significantly intensified. The NMPA has developed its own requirements for quality management systems. These ‘Good Manufacturing Practice’ requirements are very similar to ISO 13485, subsequently, ISO 13485 certificates tend to be recognized until now. However, overseas inspections can officially be performed in accordance with the Chinese GMP requirements. This is especially the case if there are reasons for an overseas inspection, for instance, if information on the certificate deviate from product information or a product is considered to bear high risk.

Improvement of risk management

Shortly after the founding of the NMPA, a regulation on ‘Adverse Events Reporting’ was issued. The purpose of this provision is to increase the responsibility of both, manufacturers and NMPA Legal Agents, to proactively monitor information on quality issues. The system is designed to improve the risk management of medical devices after commercialization. It aims to supervise, evaluate and resolve reported issues in medical devices.
In addition, the NMPA is responsible for the inspection system, the investigation and handling of illegal activities of medical devices, pharmaceuticals and cosmetics; and organizes the investigation and penalty of such illegal activities. It also oversees the inspection of medical devices, pharmaceuticals and cosmetics.

In the field of cosmetics approval, the NMPA has issued a significant relief for so-called ‘non-special’ cosmetics. Instead of registration, they would only have to be filed with the NMPA in Beijing or local Food and Drug Administrations (FDA) in one of ten pilot cities. This process is faster than the registration of ‘special cosmetics’, which are products with certain claims such as hair growth or skin whitening, etc. In addition, a filing does not have to be renewed, unlike a registration which has to be renewed every four years. However, the NMPA Responsible Person for cosmetics (formerly known as CFDA Legal Agent), carries responsibilities beyond the approval process, including product safety. To sum up, there is a similar trend in the sense that the responsibilities for medical device NMPA Legal Agent and cosmetics NMPA Responsible Person are being more and more extended and better defined.

Anna Fischer

 

 

 

About the author

With well over 100 years experience between us, we've been around the editorial and medical blocks a few times. But we're still as keen as any young pup to root out what's new and inspiring.

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