Chapter 5 Design and Development
Article 36 The manufacturing enterprise shall prepare and maintain the procedure documents for the design and development, and implement the planning and control of the process of the design and development of medical devices.
Article 37 The manufacturer shall identify the design and development phases and the review, verification, validation and design conversion activities of each phase. Shall identify and determine the activities and interfaces of each department design and development, clear responsibilities and division of labor.
The design and development stages of a product can be divided into: feasibility study, trial production, batch trial production and formal production. Manufacturing enterprises can be refined or simplified according to the complexity of specific product design and development, but should include at least two stages of feasibility studies and trial production.
Article 38 The design and development inputs shall include the specified function, performance and safety requirements related to the intended use, regulatory requirements, risk management documents and other requirements. Design and development inputs shall be documented and reviewed and approved.
Article 39 The design and development outputs shall meet the design input requirements, make clear provisions for each stage, and provide the basis for procurement, production and service and the guidelines for product acceptance, and stipulate the safety of the product and the product characteristics necessary for normal use. Design and development outputs shall be approved prior to release. Records of design and development outputs shall be maintained, including specifications identified after review of medical device registrations.
Article 40 The manufacturer shall carry out design transformation activities during the design and development process so that the design and development output can be verified before becoming the final product specification to ensure that the design and development output is suitable for production.
Article 41 The manufacturer shall arrange for review at the appropriate stage of design and development, and keep records of the results of the review and any necessary measures. The appropriate stages shall at least include the feasibility study, the trial production stage, and other stages deemed necessary by the enterprise.
Article 42 The manufacturer shall carry out verification of the design and development to ensure that the design and development output meets the requirements of the input, and keep records of the verification results and any necessary measures.
Article 43 The production enterprise shall carry out validation of the design and development to ensure that the product meets the requirements of the specified use or the requirements of the known intended use, and maintain a record of the validation results and any necessary measures.
Design and development does recognize the use of clinical evaluation, performance evaluation. Clinical trials should be conducted in accordance with the requirements of the regulations for clinical trials of medical devices; performance evaluation should be conducted in accordance with the requirements of the regulations for registration and management practices.
Article 44 The manufacturer shall design and development of changes to identify and maintain records. When the design changes beyond the product acceptance guidelines, or affect the product safety, effectiveness, design and development changes should be evaluated, verified and confirmed, and approved before implementation.
Elected materials, parts or product function changes may affect product safety, effectiveness, should be in line with the requirements of relevant regulations.
Article 45 The manufacturer shall formulate and document the requirements for risk management and maintain relevant records in the whole process of product realization including design and development.
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