Drugdu.com expert's response:

To swiftly apply for Class II and Class III medical device certificates, it is essential to clarify the classification requirements, prepare complete materials, submit the application according to the process, and actively cooperate with the review. Additionally, leveraging professional agency services can enhance efficiency. Below is a detailed explanation:

I. Clarify Classification and Requirements

Class II Medical Devices: These pose moderate risks and require either business registration or production licensing.

Class III Medical Devices: These carry higher risks and must obtain business licensing or production licensing.

II. Prepare Application Materials

Class II Medical Device Business Registration Materials

Registration Application Form: Requires the signature of the legal representative and the company seal.

Corporate Qualification Proof: Includes a copy of the business license, with the business scope including "Class II medical device sales" or similar wording.

Personnel Qualification Proof: Identification documents and educational or professional title certificates of the company's legal representative, responsible person, and quality management personnel. At least one staff member with a college degree or above in a medical device-related field, or with relevant work experience, is required.

Business Premises and Warehouse Proof: Includes property ownership or lease certificates, as well as warehouse property ownership or usage rights certificates (for consigned storage, a consignment agreement is required, and the consignee's service scope must include the consignor's business scope). Business premises and warehouses must meet storage requirements, such as temperature and humidity control and zoning management.

Quality Management Documents: Include systems for incoming goods inspection, storage management, etc.

Other Materials: Such as the medical device business scope (must comply with the medical device classification catalog), a directory of business quality management systems and work procedures documents, etc.

Class III Medical Device Business License Application Materials

Business License Application Form: Requires detailed filling out of company information, business scope, etc.

Corporate Qualification Proof: Includes a copy of the business license, with the business scope explicitly including "Class III medical device business."

Personnel Qualification Proof: At least two relevant professionals are required, with one possessing a bachelor's degree or above in a medical device-related field or an intermediate or higher professional title. Identification documents, educational certificates, or professional title certificates, as well as resumes, of the proposed legal representative, responsible person, and quality management personnel must be provided.

Business Premises and Warehouse Proof: Includes property ownership or lease certificates, as well as layout plans of the business premises and warehouse. Business premises and warehouses must meet higher requirements, such as independent areas and professional equipment.

Quality Management Documents: Include management systems for procurement, acceptance, storage, sales, and after-sales service.

Other Materials: Such as a list of technical personnel with their educational and professional title certificates, a directory of business quality management standard documents, a description of the company's installed product purchase, sales, and inventory information management system (if any), a directory of warehousing facilities and equipment, a statement of assurance from quality management personnel regarding their on-the-job status, and a statement of assurance regarding the authenticity of the application materials, etc.

III. Application Process

Online Application: Submit the application on the provincial government service website or the relevant drug regulatory authority's website.

Material Review: Pre-review personnel conduct a formal review of the submitted materials in accordance with regulations. Materials that are complete and meet the requirements are accepted; those that are incomplete or do not meet the requirements will be notified of the necessary supplements all at once.

Technical Review (for Class III Medical Devices only): After initial review and acceptance, the materials are transferred to a technical review agency for technical assessment. The technical review agency must complete the assessment within the specified time, with additional time counted for external expert reviews.

On-site Inspection: The regulatory authority may conduct on-site inspections of the business premises and warehouses to understand the production technology, equipment, and environmental conditions.

License Decision: After the technical review, the regulatory authority makes a decision based on the review and assessment results. If the requirements for safety and effectiveness are met, registration is approved or a business license is issued.

Certificate Delivery: Within the specified time from the date of the approval decision, the regulatory authority delivers the administrative license decision electronic certificate or paper certificate.

IV. Suggestions for Accelerating the Application

Early Preparation: Familiarize yourself with the application process and required materials in advance to ensure completeness and accuracy.

Professional Guidance: Seek assistance from professional agency services or consult the relevant regulatory authority for guidance to ensure a smooth application process.

Active Cooperation: Actively cooperate with the regulatory authority's review and on-site inspection work during the application process.

Monitor Progress: Keep track of the approval progress and notifications to ensure all steps are completed within the specified time.