Absorbable medical device business qualification application process and key points

According to the "Medical Device Business Supervision and Management Measures" (State Food and Drug Administration Order No. 8), if engaged in the operation of Class III medical devices, the business enterprise shall apply to the municipal-level food and drug supervision and management department of the place where it is located and obtain the "Medical Device Business License" before it can operate.

Business License Application Process

Application materials (details depend on the regulations of the Municipal Bureau)

(i) Application form for establishment of medical device business enterprise;

(ii) Copy of business license;

(iii) Copy of identity certificate, education background or professional title certificate of legal representative, enterprise manager and quality manager;

(iv) Description of organizational structure and departmental setting;

(v) Geographic location map, floor plan, property ownership certificate or copy of lease agreement (with property ownership certificate) of business premises and warehouse address;

(vi) Directory of documents such as business quality management system and work procedures;

(vii) Basic introduction and function description of computer information management system.

Fees

Free

On-site inspection

On-site inspection shall be carried out in accordance with the "Guidelines for On-site Inspection of Medical Device Business Quality Management Standards". Enterprises may conduct self-inspection first and prepare corresponding forms and documents in accordance with the guidelines.

Change of business license

1. Change of business premises, warehouse address (excluding the establishment of new independent business premises), business mode, business scope and other licensing matters require on-site inspection, and submit relevant certification materials for the changes. If the business scope is changed, a catalog of products to be added and a copy of the registration certificate must be submitted.

2. No on-site inspection is required for changes in registration items.

Business license renewal

Medical device operating companies should apply to the original issuing department for renewal of the "Medical Device Business License" 6 months before the expiration of the validity period.