Medical Devices is one of the sectors selected for Outcome 1 of the UK-China Business Environment Programme Standards Strand: improvement in the adoption and use of International Standards in China.

As the second largest medical devices market in the world and a major global supplier of medical devices, China has been developing and improving its policies in recent years to facilitate the fast-growing industry and stimulate innovation. This growth poses massive challenges for the Chinese government to establish efficient inspection and approval systems to offer products accessible for both domestic and overseas users while ensuring the safety and efficacy of the products.

COVID-19 and the global pandemic has brought the global medical device industry into focus. The unprecedented global demand for a wide range of medical devices such as diagnostic equipment, PPE, and hospital furniture has placed the supply of these items and the approval for use by authorities under increased scrutiny.

The aim is to meet the urgent demand for rapid diagnostic testing, a vaccine, intelligent body temperature measurement, and more. The use of standards for quality and efficacy will play an important part in the ongoing regulation of these devices and provide a significant benefit for importers and suppliers who have experienced problems getting products approved for use in China.

Common standards and international recognition of conformity to these standards reduces technical barriers and opens markets to trade between China and the UK (and other nations)

  • UK Medical Device suppliers will benefit from more open markets
  • Health providers and funders can benefit from increased supply options

Step 1 – Adoption of standards

  • Develop and publish National Standards in the field of Medical Devices in China
  • Agree a programme of work that includes the adoption of internationally approved standards related to Medical Devices in China
  • Adoption of International Standards for Medical Devices published in China
  • Widespread use of internationally aligned standards for Medical Devices in China

Step 2 – Piloting of standards

  • BSI and NMPA have proposed to pilot the implementation of an international Medical Device standard in China

Pilot option 1: Implementation of Safety Assessment guidelines for Medical Devices to develop capacity for the assurance of safety.

Pilot option 2: The adoption of Medical Device standards in given areas of technology.