Sunday , 3 March 2024

A Study on medical devices as per EU and CHINA

Gudapati Sirisha*, Yarra Sai Phanindra, Adapa Haritha Naga Vara Lakshmi, Doonaboyina Raghava, Kavala Nageswara Rao
Department of Pharmaceutical Drug Regulatory Affairs, K.G.R.L College of Pharmacy, Bhimavaram-534201, Andhra Pradesh, India

A B S T R A C T
Medical devices are used in many diverse settings, for example, by laypersons at home, by paramedical staff and clinicians in remote clinics, by opticians and dentists and by health-care professionals in advanced medical facilities, for prevention and screening and in palliative care. Such health technologies are used to diagnose illness, to monitor treatments, to assist disabled people and to intervene and treat illnesses, both acute and chronic. According to the current medical devices legislative framework, the EMA mainly provides scientific opinions to notified bodies through consultation procedures. The EU revised the laws governing medical devices and in-vitro diagnostics to align with the development of the sector over the last 20 years to ensure transparent and regulatory framework and maintain a high level of safety, while supporting innovation. The reason behind the changes of regulations is to strengthening of post-market surveillance requirements for manufacturers, improved coordination mechanisms between EU countries on vigilance and market surveillance. The reason behind the changes of regulations is to strengthening of post-market surveillance requirements for manufacturers, improved coordination mechanisms between EU countries on vigilance and market surveillance. The Chinese government has promulgated the New Regulations, which covers various perspectives of the regulatory regime of medical devices, such as device classification and registration, supervision of production and distribution, etc. The recent update is particularly comprehensive, with nearly every kind of device affected. Between this update from the NMPA and their recent electro-medical safety update, it is absolutely imperative for manufacturers marketing products in China to stay informed of which standards are changing. So they can take immediate action to comply with the new requirements. The new changes further specify the definition of a Market Authorization Holder and explain its responsibilities. The new 2018 draft amendment also explains the creation of a Unique Device Identification (UDI) system by the NMPA. By 2030, according to a 2018 KPMG report China is expected to have more than 25 percent share of the global medical device industry. Prior to Covid-19, China medical devices market was growing at twice the pace of the overall market, driven by the healthcare reform and overall rising demand for healthcare. Driven by the more powerful regulatory requirements under the New Regulations, the Chinese medical device market will become increasingly dynamic in the future.

Keywords: Medical devices, Regulations, MDR, NMPA, EMA, CFDA, PRC, Conformitte European

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