China: Medical Device's Compulsory Updates by NMPA

1. Change Application as New Compliance-to-Maintain Requirement

The National Medical Products Administration of China (NMPA) published an update regarding compulsory standards of medical devices on November 2022. Manufacturers need to be well informed on news released so that action can be taken immediately. Based on updates by NMPA previously, it shows that major type of devices is affected and requires changing action. Manufacturers may use this site to find more details about the medical devices affected by the new changes by NMPA.

Upon the latest requirement being published, manufacturers now have to notify Change Notification before renewal application submission. Compare to before, any related standards changes may be included in the renewal application for International Medical Certificate (IMDRC). The new requirement might cause a time extension for the renewal process as manufacturers should notify the Change Notification.

Source: China Medical Device Evaluation

2. Further Details on Timeline and Standards Testing

Manufacturers must note the important information below to ensure no delay or disturbance occurs while marketing their products in China. Manufacturers are also advised to communicate well with agents in China to ensure their Imported Medical Device Registration Certificate (IMDRC) has no interruption. Below is a summary of the details:

1. The manufacturer should confirm whether the product is required to undergo in-country testing for new standards.

2. To prove standards compliance, the manufacturer must acquire test reports from the qualified test lab in China. Note that, the report may be issued by a qualified third-party test lab.

3. Submission for renewal application can be done 6 months before the expiration date. While Change Application approval should be done between 7 to 12 months before the expiration date.

4. For any renewal application done 6 months before the expiration date and rejected, the manufacturer may resubmit the renewal application once received approval for the Change Application.

5. If the manufacturer submits a renewal application within 6 months, compliance issues are detected and failure to resubmit the application, the manufacturer has to submit a new application.

6. Important to take note that, Change Application is compulsory. For the products that are incompliant with new standards, no renewal approval will be issued for the manufacturer.

2.1. Standards Update by Product Type (Compulsory)

Implementation dates for the requirement of the new standards are different by product type. There are some starting implemented by 2022 while some start in 2023. It is advisable for manufacturers and regulatory professionals to stay close to regulatory standards updates in China for the latest updates. Hence, manufacturers may update the documentation for products to be in the market according to the plan.

The table below is an example of some product categories and implementation dates:

Source: NMPA

3. Electrical Safety Standards Update (Medical Devices)

Electromedical safety standards are also affected by the latest requirement update and will be fully implemented by May 2023. The manufacturers can check further details on this site.

Manufacturers should be aware of the electromedical devices market, products should be tested to the new standards, and acquire qualified certifications before submitting the renewal application. Otherwise, NMPA would not issue the renewal application. Qualification tests could take up to 12 months. The manufacturers can refer to the chart below for steps to obtain new electromedical safety standards.

Source: chinesestandard

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