Drugdu.com expert's response:

Medical device companies must obtain corresponding qualifications based on their business type (manufacturing or distribution) and product classification (Class I, II, or III). The details are as follows:

I. Manufacturing Qualifications

Class I Medical Devices

Qualification Name: Class I Medical Device Production Filing Certificate

Issuing Authority: Municipal-level drug regulatory administration (at the district level)

Requirements:

Possess compliant production facilities (e.g., cleanrooms) and equipment (e.g., calibrated instruments), along with quality management system documentation (e.g., quality manuals, work instructions).

Submit materials including business license, proof of production site usage rights, and equipment inventory.

Class II and Class III Medical Devices

Qualification Name: Medical Device Manufacturing License

Issuing Authority: Provincial drug regulatory administration (for Class II) or National Medical Products Administration (for Class III)

Requirements:

Production sites must meet cleanliness, temperature, and humidity standards, with advanced equipment subject to regular calibration.

The quality management system must cover procurement, production, and inspection processes, and comply with certifications such as ISO 13485.

Submit materials including business license, proof of production site, equipment inventory, and quality management system documentation.

II. Distribution Qualifications

Class I Medical Devices

Qualification Requirements: No license or filing required; only a business license with medical device sales included in the scope is needed.

Class II Medical Devices

Qualification Name: Class II Medical Device Distribution Filing Certificate

Issuing Authority: Municipal-level drug regulatory administration

Requirements:

Distribution premises and warehouses must be independent and non-residential, with a minimum area of 30 square meters (higher requirements in some regions).

Employ at least one individual with a junior college degree in a medical-related field or a licensed inspector to oversee quality management.

Submit materials including business license, proof of distribution premises, and personnel qualification certificates.

Class III Medical Devices

Qualification Name: Medical Device Distribution License

Issuing Authority: Municipal-level drug regulatory administration

Requirements:

Distribution premises and warehouses must be office-based, with a minimum area of 45 square meters (higher requirements for key regulated products).

Employ at least three professionals (e.g., company负责人/responsible person, quality manager, quality inspector) holding relevant certificates (e.g., junior college degrees or intermediate professional titles in pharmacy or medicine).

For in vitro diagnostic reagents, cold storage and professional refrigerated transportation equipment are required.

Submit materials including business license, proof of distribution premises, personnel qualification certificates, product registration certificates, and quality management system documentation.

III. General Qualifications

Medical Device Registration/Filing Certificate

Scope: All medical device products must complete registration or filing before market launch.

Issuing Authority: National Medical Products Administration (for Class III), provincial drug regulatory administration (for Class II), or municipal-level drug regulatory administration (for Class I).

Requirements: Submit materials including product technical requirements, clinical trial reports (required for Class III), and product instructions. Upon approval, a registration certificate or filing certificate is issued.

Quality Management System Certification

Common Certification: ISO 13485 Medical Device Quality Management System Certification.

Requirements: Establish a quality management system covering product design, production, sales, and after-sales service, and pass third-party certification audits.

IV. Special Product Qualifications

Imported Medical Devices

Must undergo filing or registration with the National Medical Products Administration and obtain an Imported Medical Device Registration Certificate or Filing Certificate.

Combination Products (e.g., Drug-Device Combinations)

Products primarily functioning as medical devices (e.g., medicated dressings) are classified as Class III and must comply with Class III requirements.

Sterile Products

Medical devices provided in sterile form (e.g., disposable syringes) are classified no lower than Class II and must meet sterile production requirements.