Bryan Gilburg - China

“All Class III products, including those already on the market, must now have UDI labeling.”

Bryan Gilburg

Managing Director

Come grow with us in the US in Thailand in China in Korea in the Philippines in Taiwan in Hong Kong

Sign Up For Our Newsletter to Stay Informed

China Fully Implements UDI Requirements for Class III Medical Devices

Published on: June 1st, 2022

Beginning January 1, 2021, the NMPA began implementing UDI requirements in China for the first batch of 69 types of medical devices in 9 categories. In accordance with NMPA Notice No.114, 2021, all remaining Class Ⅲ medical devices (including IVDs) are subject to UDI implementation from June 1, 2022.

All the class Ⅲ medical devices registrants shall take actions to meet the following requirements:

  1. From June 1st, 2022, all the newly produced medical devices should have UDI.
  2. From June 1st, 2022, when applying for initial registration, registration renewal or registration change, the registrants shall submit the product UDI of its minimum sales unit.
  3. From June 1, 2022, before marketing, for the newly produced medical devices, registrants shall upload the UDI data related to the products to the unique identification database of medical devices and ensure that the data are true, accurate, complete and traceable.

What is UDI?

UDI is an international system for identifying Medical Devices (MDs) meant to help quickly identify people affected by product recalls, device failures, or serious adverse events. UDI has been adopted by the International Medical Device Regulators Forum (IMDRF) to help harmonize global implementations and is in different stages of implementation around the world. UDI consists of a bar code and a numerical or alphanumerical system that quickly identifies the Device model, the Production information (batch/lot, software version, etc.), and Data delimiters.

For more information on UDI in Singapore, please see our blog on the topic here.

Come Grow With Us

Please contact us if you’d like support understanding these new requirements or are interested in registering your product in China. Asia Actual specializes in helping medical device manufacturers grow their sales in Asia with experienced, bi-lingual commercial and regulatory experts on the ground in each market. Contact Asia Actual today with any questions or support requests.

Asia Actual is a regulatory consulting company specializing in helping manufacturers grow their sales through independent license holding, direct fulfillment, and a variety of sales channel support services.

Blog Posts

Thai FDA Implements Initial Screening Step to Submission Process

Beginning August 1st, 2022, the Thai FDA implemented a new screening submission process applicable to almost all applications.

Indonesia Issues New Guidance for Freezing Medical Devices on eCatalogue

On July 6, 2022, the Ministry of Health released updated guidance outlining the process for freezing medical device categories on the eCatalogue,

Medical Device Advertising Requirements in Asia

In addition to receiving market authorization for the safety and efficacy of their product, manufacturers wishing to advertise their medical devices, especially Direct to Consumer, may need to also obtain approval for their marketing material.