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Q&A – China NMPA Classification

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Frequently Asked Questions about China NMPA Registration for medical devices and IVDs:

Who is responsible for medical device classification and registration in China?

China’s National Medical Products Administration (NMPA) is responsible for the regulation of medical devices and drugs in China.

Formerly named the China Food & Drug Administration (CFDA), the CFDA was established in 1998 to oversee medical devices, drugs and food (as of 2003). In March 2018, CFDA became NMPA with a focus on regulating pharmaceuticals and medical devices.

Under this new charter, NMPA’s Department of Medical Device Registration began managing registration for domestic Class III and imported Class I, Class II, and Class III devices. This department’s other responsibilities include managing classification, optimizing control procedures, and ensuring good manufacturing practices (GMPs). The provincial NMPA is responsible for domestic Class I and Class II devices.

NMPA’s Department of Medical Device Supervision is tasked with ensuring product quality and safety, and the department’s responsibilities include:

  • Address issues with medical device manufacturing and distribution
  • Evaluate problems with medical devices and monitor adverse events
  • Reassess products after reported events
  • Recommend modifications to systems and processes to help mitigate adverse events

 

How are China’s medical devices and IVDs classified?

With classification similarities to US and European standards, China NMPA categorizes medical devices and IVDs into three classes. For medical devices, classifications are based on their potential risk to patients. Class I is the lowest risk, and Class III is the most complex and of highest risk.

Medical Device Classifications

  • Class I: Low-risk medical devices whose safety and effectiveness are ensured through routine administration
  • Class II: Mid-risk medical devices that require further control to ensure their safety and effectiveness
  • Class III: High-risk medical devices that are implanted into the human body, used to support or sustain life, or pose potential risk to the human body and thus, must be strictly controlled for safety and effectiveness

 

IVD Classifications

  • Class I:
    • Microbiological media (not used for microbiological identification and susceptibility testing)
    • Sample processing products (hemolytic agents, diluents and dyeing solutions)
  • Class II:
    • Except for the reagents that are classified as Class I and Class III, all the other reagents are Class II.
  • Class III includes reagents related to:
    • Testing of pathogenic antigens, antibodies and nucleic acids
    • Blood type and tissue type
    • Human genetic testing
    • Hereditary diseases
    • Narcotic drugs, psychotropic substances and medical toxic drug testing
    • Therapeutic targets detection
    • Tumor marker detection
    • Allergen testing

 

The current China Medical Device Catalog also classifies products into 22 categories.


For a complete version of the catalog, please email info@ChinaMedDevice.com. For new China NMPA registration, renewal and modifications, please email info@ChinaMedDevice.com for a free 15-minute consultation.

For overseas manufacturers: What do I need to know about registering a medical device in China?

NMPA registration is now valid for five years and only required for Class II and Class III devices due to their higher patient risks. Class I devices do not require registration, but device filing is still required.

To register a medical device manufactured outside of China, a company must complete the following process:

  • Submit device samples to China NMPA for analysis.
  • Ensure all product information, packaging, and labeling include Chinese translation.
  • For Class II and Class III devices, provide documented proof of device approval from country of origin.
  • For Class II and Class III devices, provide additional data from clinical trials if requested.
  • Hire a China-based agent to register products outside of China. The agent manages the NMPA registration and clinical trial process, mitigates adverse events in the case of device malfunction, provides maintenance and technical support, and can assist with device recall if required.

 

What are the key changes of China’s NMPA Medical Device Classification System?

China’s current NMPA Medical Device Classification System was implemented on August 1, 2018. The system specifies that “classifications should be based on the Device Category, Subcategory, Example of Device Names, Product Description and Intended Use.”

Compared with the previous catalog system, the key changes are:

  • Number of device categories have decreased from 43 to 22
  • 1,157 Class II subcategories added
  • Number of device names has increased from 1,008 to 6,609
  • There are now 40 reclassifications
  • Diagnostic artificial intelligence added
  • Product description and intended use added to determine right classification
  • Sterilized and non-sterilized device difference, under same category and subcategory, now shown in product description

 

As of August 1, 2018, the previous classification catalog for Class II and III devices became obsolete. Class I device classification now relies on the new catalog and other currently available resources.

Please note, the new catalog only applies to medical devices. The existing NMPA (CFDA) catalog system continues to work for IVD products. For questions regarding IVD classifications, please email us at info@ChinaMedDevice.com.

 
What are the recent updates relating to classifications for medical devices and IVDs in China?
 
NMPA No. 147 Announcement on Adjusting Part of the “Medical Devices Catalogue” was implemented on December 18, 2020. The announcement stated:


To further deepen the reform of the medical device review and approval system, in accordance with the actual development and supervision of the medical device industry, and the relevant requirements of the Regulations on the Supervision and Administration of Medical Devices, the State Food and Drug Administration, currently named as NMPA has decided to adjust some of the contents of the “Medical Device Classification Catalogue”. The relevant matters are hereby announced as follows:
  
The contents of the “Medical Device Classification Catalogue” of 28 types of medical devices were adjusted. Among them, the management categories of 15 types of medical devices were adjusted, and the contents of the 13 categories of medical devices were adjusted.

 
What is the Dynamic Adjustment of working procedures for the Medical Device Classification Catalog?

To strengthen the classification management of medical devices, standardize the dynamic adjustment of the “Medical Device Classification Catalog” (herein referred to as the “Category Catalog”), and formulate this work procedure in accordance with “Regulations on the Supervision and Administration of Medical Devices” and the “Medical Device Classification Rules”.

Implemented on April 27, 2021, the dynamic adjustment of the “Category Catalog” was based on changes in the risks of medical devices, referring to international experience, and conforms to the latest scientific knowledge and principles based on regulatory practices, encouraging innovation, and promoting the high-quality development of the industry.

The dynamic adjustment of the “Category Catalog” includes the following situations:

  1. Adjust the sub-category
  2. Adjust the primary product category, secondary product category, and/or management category
  3. Adding representative innovative medical device products
  4. Delete products that are no longer managed as medical devices
  5. Revise the content of product description, intended use, and product name examples