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Since January 1, 2021, China has streamlined regulatory documents for import and export from 86 to 44 types. Following further consolidation and cancellation, the number has been reduced to 41 types.

Among these, key commodity inspection certificates requiring port verification include:

• Medical Device Filing/Registration Certificate
• Special Equipment Manufacturing License & Type Test Certificate
• Compulsory Product Certification (CCC) Certificate or Exemption Document

All above certificates require verification during import procedures. Below we explain these certificates in detail.

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Certificates Subject to Verification

1. Medical Device Filing/Registration Certificate

Medical devices sold or used in China must undergo registration or filing procedures:

• Class I devices: Filing management
• Class II & III devices: Registration management

Medical Device Filing: The filing applicant submits documentation to medical device regulatory authorities.

Medical Device Registration: Regulatory authorities evaluate safety and effectiveness of devices prior to market approval, following statutory procedures.

Manufacturers and filing applicants must maintain full life-cycle quality management and assume legal responsibility for device safety and effectiveness throughout development, production, distribution, and use.

2. Special Equipment Manufacturing License & Type Test Certificate

China implements a licensing system for special equipment manufacturing based on classified supervision principles. Manufacturers must ensure compliance with safety technical specifications and relevant standards, and assume responsibility for equipment safety performance.

Manufacturing of equipment that fails to meet safety requirements, energy efficiency indicators, or state-eliminated products is prohibited.

3. CCC Certificate/Exemption Document

The Compulsory Product Certification (CCC) serves as market access requirement to protect national security, human health and safety, environmental protection, and plant/animal life.

Products listed in the CCC catalog must obtain certification from CNCA-designated certification bodies, undergoing mandatory testing and audit procedures.

CCC Exemption applies to products falling under six special circumstances:

• Products and samples for research, testing, or certification
• Components for end-user repair purposes
• Equipment components for complete production lines (excluding office supplies)
• Products for commercial display only (not for sale)
• Imported components for fully exported finished products
• Other special circumstances exempted from CCC requirements

Applicants must obtain CCC exemption certificates before customs declaration.

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Purpose of These Certificates

While different certificates serve different industry-specific purposes, their overarching goal is to ensure public health and safety, protect life and property, and maintain normal socioeconomic order:

• Medical device registration/filing ensures medical device safety and effectiveness
• Special equipment licensing ensures safe operation and accident prevention
• CCC certification protects national security and public interests

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Application Procedures

Medical Device Certificate

China classifies medical devices into three risk-based categories:

Domestic Devices:

• Class I: Filing with municipal medical device regulatory departments
• Class II: Registration with provincial-level regulatory departments
• Class III: Registration with State medical device regulatory department

Imported Devices:

• Class I: Filing by Chinese legal entity designated by overseas applicant with State department
• Class II & III: Registration by Chinese legal entity designated by overseas applicant with State department
• Innovative devices not marketed overseas may be exempt from home country approval documents

Hong Kong, Macau, and Taiwan medical devices follow import device procedures.

Special Equipment Manufacturing License

According to SAMR Announcement No. 3 (2019):

• Overseas pressure equipment requires manufacturing license with same parameter levels as domestic equipment
• Imported electromechanical special equipment requires type testing certificate before use

Applicants should process through local market regulation departments, including application, acceptance, product trial production, type testing, evaluation, approval, and certification.

CCC Certification

Products listed in the CCC catalog must obtain certification from CNCA-designated agencies through:

• Application acceptance
• Document review
• Sample testing
• Factory inspection
• Conformity assessment
• Certificate approval

For CCC exemption applications, refer to our separate guide.

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Customs Declaration Procedures

Since 2018, the General Administration of Customs, SAMR, and National Medical Products Administration have established computerized verification, notification, and coordination mechanisms for these certificates.

After obtaining relevant certificates, enterprises should:

1. Upload required documents to China’s Single Window system
2. Complete declaration according to product-specific requirements
3. The system automatically verifies certificate information
4. Mismatched information will trigger system alerts

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Legal Compliance Warning

According to Customs Law of the People’s Republic of China:

• Import consignees and export consignors must declare truthfully to customs and submit required licenses
• Goods subject to import/export restrictions without proper licenses will not be released

According to Implementation Regulations of Customs Administrative Penalties:

• Failure to submit required licenses for restricted goods may result in:
  • Goods not being released
  • Fines up to 30% of goods value

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Our Services

We provide comprehensive support for international companies navigating China’s commodity inspection requirements:

• Certificate Eligibility Assessment – Determine which certificates your products require
• End-to-End Certificate Application Management – Complete handling of medical device, special equipment, and CCC certification processes
• CCC Exemption Application Services – Professional assistance with exemption applications for eligible products
• Customs Declaration Support – Guidance on Single Window declaration and document submission
• Compliance Advisory – Ongoing support to ensure adherence to Chinese regulations
• Pre-import Verification – Confirm all certificate requirements before shipment
• Regulatory Updates – Timely notifications about changes in Chinese inspection requirements

Let us streamline your market entry process – ensuring compliance while saving time and resources.