Drugdu.com expert's response:

The production of Class I medical devices requires compliance with the following conditions, covering five core aspects: production facilities, equipment, personnel, quality management systems, and regulatory compliance:

I. Production Facilities and Environmental Conditions

1. Facility Requirements

Production sites must be clean, suitable, and meet the needs of manufacturing processes and quality control. For example, workshops producing medical cotton swabs must maintain hygiene to prevent microbial contamination. For devices with special environmental requirements (e.g., sterile products), compliance with cleanroom standards (such as YY0033 Management Standard for Sterile Medical Device Production) is mandatory.

Production facilities must align with production scale and product characteristics, ensuring rational spatial layout to avoid cross-contamination.

2. Environmental Control

Depending on product risk levels, some Class I devices may require controlled environmental parameters like temperature, humidity, or cleanliness. For instance, workshops producing liquid dressings must maintain constant temperature and humidity.

II. Production Equipment and Inspection Facilities

1. Production Equipment

Enterprises must equip themselves with production machinery appropriate for their products, such as reaction vessels, dryers, or filling machines. Equipment must undergo regular calibration to ensure precision and stability.

Equipment layout must follow workflow processes to prevent material backflow or cross-contamination.

2. Inspection Facilities

A quality inspection department or dedicated inspectors must be established, equipped with necessary tools (e.g., microscopes, balances, microbial testing equipment) to inspect raw materials, semi-finished products, and finished goods.

III. Professional Personnel and Qualifications

1. Key Personnel

Production, Quality, and Technical Leaders: Must possess professional expertise relevant to the medical devices produced, be familiar with regulations (e.g., Medical Device Supervision and Administration Regulations), and technical standards. The quality leader cannot concurrently serve as the production leader.

Technical Staff: The proportion of personnel with junior professional titles or secondary vocational education or higher must match product complexity. For example, more professionals are required for intricate devices.

2. Training and Responsibilities

Key personnel must undergo regular training to stay updated on regulations and technical requirements. For example, quality leaders must be proficient in ISO 13485 quality management systems.

IV. Quality Management Systems and Documentation

1. Quality Management System

Enterprises must establish a quality management system covering raw material procurement, production process control, product inspection, and after-sales service. Examples include implementing incoming inspection, production records, and finished product release procedures.

Compliance with the Good Manufacturing Practice (GMP) for Medical Device Production is required to ensure product traceability.

2. Documentation Management

Relevant regulations, standards, and technical documents (e.g., product technical requirements, process flowcharts, equipment operation manuals) must be retained.

Critical data from production, inspection, and sales must be recorded to ensure authenticity, completeness, and traceability.

V. Regulatory Compliance and Filing Requirements

1. Enterprise Qualifications

Enterprises must be legally registered as independent legal entities with a business license that includes medical device production in their scope.

2. Filing Process

Submit a Class I Medical Device Production Filing Form and the following materials to the municipal-level drug regulatory authority:

Copy of business license;

Production site proof (e.g., property certificate or lease agreement);

List of production and inspection equipment;

Quality management system documents;

Qualification certificates for key personnel (e.g., educational or professional title certificates).

After filing, production activities may commence without a production license.

3. Dynamic Management

Changes in production conditions (e.g., site relocation, equipment updates) must be promptly reported to the filing authority for updates.

Example Scenarios

Medical Cotton Swabs: Requires a clean workshop, drying equipment, cutting machines, microbial inspectors, and systems for incoming inspection (e.g., testing swab stick materials) and finished product testing (e.g., sterility tests). Filing with the municipal drug regulatory bureau is mandatory.

Sterile Medical Dressings: Requires a cleanroom (e.g., Class 100,000 clean workshop), ethylene oxide sterilization equipment, and submission of cleanroom test reports as part of the filing materials.