China, Medical Device Regulations. What do you need to know?

National Medical Products Administration (NMPA) is in charge of all pharmaceuticals and medical device regulations in China.

Medical devices are being classified into 3 classes. All according to their potential risks. Class I (Lowest), Class II (Middle) & Class III (Highest).

A further breakdown in the specifics of the 3 classes;

Class I – All devices in which safety and effectiveness can be assured through routine administration.

Class II – All devices involving further controls and monitoring in order to ensure safety and effectiveness.

Class III –All devices used for life support or sustenance, which might be a potential threat to health or relating to any implants into the human body.

If a medical device not manufactured in China wants to be registered in the Chinese market, device samples are required to be sent to NMPA for testing.

All product information on both packaging and labeling must be translated to Simplified Chinese.

The Medical device registration validity is 5 years. If a renewal should be required, the application should be submitted 6 months in advance before the expiry date.

Foreign manufacturers and brands must hire China-based agents to represent their brand in the Chinese market.

Japan, Changes to medical device regulations. What you need to know?

An official announcement was made in regards to the adoption of a new version of the Pharmaceuticals and Medical Devices (PMD) Act.

The latest version of the PMD Act covers issues such as

  • Application of Artificial Intelligence
  • Unique Device Identifiers
  • Instructions For Use provided in electronic form

There were also changes made to the requirements relating to pre-marketing application submission and post-marketing surveillance.

The goals of this new change are,

  • Simplification of access to the market to make innovative medical devices accessible to patients.
  • Providing a new vision on the functions of healthcare institutions and professionals.
  • Improvement of the regulatory compliance system.

We would see drastic improvements in compliance and supervision systems.

Thus, making communications with manufacturers more efficient through providing legal clarity and certainty of the regulatory requirements.

IMDRF released 3 documents on clinical evaluations, clinical investigations and clinical evidence for medical devices

International Medical Device Regulators Forum (IMDRF) released 3 final documents on clinical evaluations, clinical investigations and clinical evidence for medical devices.

This would replace earlier versions of the documents developed by the Global Harmonization Task Force (GHTF). The documents provides an overview of:

  • General principles of clinical evaluation for medical devices.
  • Principles for designing a clinical investigation and ethical considerations.
  • Key concepts and definitions for clinical evidence.

More details on the IMDRF website:
www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-191010-mdce-n56.pdf
www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-191010-mdce-n57.pdf

European Commission released 8 documents for unique device identifiers (UDIs) for medical devices

The European Commission released 8 documents relating to technical specifications for unique device identifiers (UDIs) for medical devices.

4 of them are relating to Basic UDI-DI, which manufacturers can use to connect and identify devices with the same purpose.  These UDI-DI documents are from GS1, HIBCC, ICCBBA and IFA respectively. The other 4 documents would deal with UDI human readable interpretation (HRI) formats, including HRI qualifiers for UDI-DI, lot number, expiration date, serial number and manufacturing dates.

More details can be found in the EC website:
https://ec.europa.eu/docsroom/documents/35241?locale=en
https://ec.europa.eu/docsroom/documents/35242?locale=en