Drugdu.com expert's response:

For trading companies and distributors that sell Class III medical devices, it is the Class III Medical Device Business License that they need to apply for. For manufacturers, the required qualifications are the Medical Device Production License and the product-specific Medical Device Registration Certificate, and these two sets of qualifications must not be confused.

The general application process for the Class III Medical Device Business License is as follows:

Confirm that the product falls into the Class III category: Look up the medical device classification and corresponding classification coding of the target product first. Different products correspond to different business scope entries, and this step will directly affect the subsequent requirements for personnel, business premises and warehousing conditions.

Prepare the required operating conditions: The enterprise needs to have a business premises that matches its operating scale, qualified quality management personnel, complete quality management rules and a computer information management system. If warehousing services are required, a warehouse that meets the official specifications must also be prepared; the requirements will be stricter for products such as cold-chain medical products and implantable interventional devices.

Prepare the application documents: Common required materials include the business license, documents of the enterprise principal and quality principal, certification documents for the business premises and warehouse, defined business scope, list of facilities and equipment, quality management system documents, and description of the computer system. The specific material list shall be subject to the requirements of the drug regulatory department where the enterprise is located.

Submit the business license application: The application is generally submitted to the municipal drug regulatory department of the locally divided district. After the materials are reviewed, the regulatory department may conduct on-site inspection, focusing on verifying whether the actual conditions of the premises, personnel, rules and operating conditions are consistent with the declared contents.

Obtain the license after approval: After getting the Class III Medical Device Business License, the enterprise can carry out corresponding Class III medical device business activities within the approved business scope.

If you are applying for the license for medical device export business, there is one extra key step to note: Obtaining the Class III Medical Device Business License in China only solves the domestic business qualification problem for Chinese enterprises, which does not mean the products can be directly exported and sold overseas. You also need to comply with the requirements of the target country, including local product registration, designated local importer/authorized representative, CE/FDA or other local regulatory certifications, as well as specifications for product labels and Instructions for Use (IFU).

Therefore, before starting the actual application process, it is best to confirm three core issues first: the specific product category, whether the applicant is a manufacturer or a trading company, and whether the business is for domestic sales or export. For example, the required qualifications and application rules may vary for different products such as monitors, endoscopes and implantable devices.