According to relevant regulations, if an enterprise wants to organize activities related to the manufacturing of Class II and Class III medical devices, it should apply for a manufacturing license from the Food and Drug Supervision and Administration Department of the local province, autonomous region, or municipality directly under the Central Government. Enterprises manufacturing Class I medical devices need to go through filing.

      A “medical device business license” should be applied for hereby at the local prefecture-level Medical Device Products Administration; applying for a “medical device business license” requires relevant conditions: having a quality manager and office space suitable for the business scope, and the quality manager should have a nationally recognized relevant majors or professional titles, business licenses, identity certificates of legal representatives, business leaders, quality managers, copies of academic qualifications or professional title certificates, etc.

How to apply for a medical device production license? What are the requirements?

Materials required for medical device production license application

  • “Application Form for Starting a Medical Device Manufacturing Enterprise” (original) (including the power of attorney and a copy of the trustee’s ID card, as well as a statement of guarantee for the authenticity of the application materials).
  • Copy of business license;
  • Copies of the registration certificate and product technical requirements of the medical devices produced by the applying enterprise;
  • Copy of the identity certificate of the legal representative and the person in charge of the enterprise; a copy of the appointment document of the person in charge of the enterprise;
  • Copies of the identity, academic qualifications, professional title certificates and work resume of the person in charge of the production, quality and technical departments;
  • Introduction to the scope, varieties and related products of the products to be produced. The product introduction should at least include a description of the product’s structural composition, principles, and intended use, as well as a list of academic qualifications and professional titles of employees in product standard production management and quality inspection positions;
  • Certification documents for the production site. If there are special production environment requirements, copies of certification documents for the facilities and environment should also be submitted; generally include copies of the house property rights certificate or lease agreement and the lessor’s property certificate, the general floor plan of the factory area, and the main production workshop floor plan
  • List of main production equipment and inspection instruments (original);
  • Quality manual and procedure documents (original);
  • Process flow chart (original);
  • Manufacturing enterprise self-examination form (original)
  • Other supporting materials. Prepare according to the specific regulations of the local food and drug administration.

Requirements for the Application of Medical Device Manufacturing License

  1. Enterprise that apply for a Class I Medical Device Manufacturing License shall have manufacturing conditions suitable for the products it produces, and shall fill in a Class I medical device manufacturing enterprise registration form within 30 days after receiving the business license and notify the local provincial, autonomous region, or municipality (food) medical device administration department in writing.
  2. Enterprises that apply for Class II and Class III medical device manufacturing licenses must meet the following requirements:
  • Persons in charge of production, quality and technology of the enterprise should have professional capabilities suitable for the medical devices produced, and master the national laws, regulations and rules on the supervision and management of medical devices as well as relevant product quality and technology regulations. The person in charge of quality shall not concurrently serve as the person in charge of production;
  • The proportion of technical personnel with junior professional titles or above or technical secondary school education or above to the total number of employees in the enterprise should be consistent with the requirements of the products produced;
  • Enterprises should have production equipment, production and storage sites and environments that are suitable for the products they produce and the scale of production. Enterprises that produce medical devices that have special requirements for the environment and equipment must comply with national standards, industry standards and relevant national regulations;
  • The enterprise should establish a quality inspection agency and have quality inspection capabilities commensurate with the varieties produced and the scale of production;
  • Enterprises should preserve laws, regulations, rules and relevant technical standards related to the production and operation of medical devices.