Manufacturers shall plan and develop the processes needed for product realization. Planning of product realization shall be consistent with the requirements of the other processes of the quality management system. In planning product realization, manufacturers shall determine the following:
(1) Quality objectives and requirements for the product;
(2) The need to establish processes, documents, and provide resources specific to the product;
(3) Required verification, validation, monitoring, inspection and test activities specific to the product and the criteria for product acceptance;
(4) Records needed to provide evidence that the realization processes and resulting product meet requirements.
The output of the above planning shall be in a form suitable for the manufacturer’s method of operations.
Manufacturers shall establish documented requirements for risk management throughout product realization.
Records arising from risk management shall be maintained.

Manufacturers shall determine the following:
(1) Requirements specified by the customer, including the requirements for delivery and post-delivery activities;
(2) Requirements not stated by the customer but necessary for specified or intended use, where known;
(3) Statutory and regulatory requirements related to the product; and
(4) Any additional requirements determined by the manufacturers.

Manufacturers shall establish and maintain documented procedures for contract review and for the coordination of these activities.

Manufacturers shall review the requirements related to the product. This review shall be conducted prior to the manufacturers' commitment to supply a product to the customer and shall ensure the following:
(1) Product requirements are defined and documented;
(2) Contract or order requirements differing from those previously expressed are resolved; and
(3) Manufacturers have the ability to meet the defined requirements.
Records of the results of above review and actions arising from the review shall be maintained.
Where the customer provides no documented statement of requirement, the customer requirements shall be confirmed by manufacturers before acceptance.
Where product requirements are changed, manufacturers shall ensure that relevant documents are amended and that relevant personnel are made aware of the changed requirements.

Manufacturers shall determine and implement effective arrangements for communicating with customers in relation to the following:
(1) Product information;
(2) Enquiries, contracts or order handling, including amendments;
(3) Customer feedback, including customer complaints; and
(4) Advisory notices.

Manufacturers shall establish documented procedures for design and development, and plan and control the design and development of product.
During the design and development planning, manufacturers shall determine the following:
(1) The design and development stages;
(2) The review, verification, validation and design transfer activities that are appropriate at each design and development stage. Design transfer activities during the design and development process ensure that design and development outputs are verified as suitable for manufacturing before becoming final production specifications; and
(3) The responsibilities and authorities for design and development.
Manufacturers shall manage the interfaces between different groups involved in design and development to ensure effective communication and clear assignment of responsibility.
Manufacturers shall document planning output and update it appropriately as the design and development progress.

Manufacturers shall determine and maintain the inputs relating to product requirements, which include the following:
(1) Functional, performance and safety requirements, according to the intended use;
(2) Applicable statutory and regulatory requirements;
(3) Where applicable, information derived from previous similar designs;
(4) Other requirements essential for design and development; and
(5) Output(s) of risk management.
Manufacturers shall review and approve inputs for adequacy.
Every requirement shall be complete, unambiguous and not in conflict with each other.

Manufacturers shall ensure the outputs of design and development be provided in a form that enables verification against the design and development input and shall be approved prior to release. Design and development outputs shall conform to the following:
(1) Meeting the input requirements for design and development;
(2) Providing appropriate information for purchasing, production and for service provision;
(3) Containing or referencing product acceptance criteria; and
(4) Specifying the characteristics of the product that are essential for its safe and proper use.
Records of the design and development outputs shall be maintained.

Manufacturers shall, at suitable stages, perform systematic reviews of design and development in accordance with planned arrangements and comply with the following requirements:
(1) Evaluating the ability of the results of design and development to meet requirements; and
(2) Identifying any problems and propose necessary actions.
Participants in such reviews shall include representatives of functions concerned with the design and development stage(s) being reviewed, as well as other specialist personnel.
Records of the results of the reviews and any necessary actions shall be maintained.

Manufacturers shall perform verification in accordance with planned arrangements to ensure that the design and development outputs have met the design and development input requirements. Records of the results of the verification and any necessary actions shall be maintained.

Manufacturers shall perform design and development validation in accordance with planned arrangements, and complete it prior to the delivery or implementation of the product to ensure that the resulting product is capable of meeting the requirements for the specified application or intended use.
Records of the results of validation and any necessary actions shall be maintained.
Manufacturers shall perform clinical evaluation and evaluation of performance of the medical device in accordance with the regulatory requirements of central competent health authority.

Manufacturers shall identify design and development changes and maintain their records. The changes shall be reviewed, verified and validated, as appropriate, and approved before implementation. The review of design and development changes shall include evaluation of the effect of the changes on constituent parts and product already delivered.
Records of the results of the review of above changes and any necessary actions shall be maintained.

Manufacturers shall establish documented procedures to ensure that purchased product conforms to specified purchase requirements.
The type and extent of control applied to the supplier and the purchased product shall be dependent upon the effect of the purchased product on subsequent product realization or the final product.
Manufacturers shall evaluate and select suppliers based on their ability to supply product in accordance with the manufacturers’ requirements. Criteria for selection, evaluation and re-evaluation shall be established. Records of the results of evaluations and any necessary actions arising from the evaluation shall be maintained.

Purchasing information shall describe the product to be purchased, including the following:
(1) Requirements for approval of product, procedures, processes and equipment;
(2) Requirements for qualification of personnel; and
(3) Quality management system requirements.
Manufacturers shall ensure the adequacy of specified purchase requirements prior to their communication to the supplier.
Manufacturers shall maintain relevant purchasing information, i.e., documents and records, according to the scope and extent required for traceability as set forth in these Regulations.

Manufacturers shall establish and implement the inspection or other activities necessary for ensuring that purchased product meets specified purchase requirements.
Where manufacturers or their customers intend to perform verification at the suppliers’ premises, the manufacturers shall state the intended verification arrangements and method of product release in the purchasing information.
Records of the above verification shall be maintained.

Manufacturers shall plan and carry out production and service provision under controlled conditions. Controlled conditions shall include the following, as applicable:
(1) The availability of information that describes the characteristics of the product;
(2) The availability of documented procedures, documented requirements, work instructions, and reference materials and reference measurement procedures as necessary;
(3) The use of suitable equipment;
(4) The availability and use of monitoring and measuring devices;
(5) The implementation of monitoring and measurement;
(6) The implementation of release, delivery and post-delivery activities; and
(7) The implementation of defined operations for labeling and packaging.
Manufacturers shall establish and maintain a record for each batch of medical devices that provides traceability to the extent specified in these Regulations and identifies the amount manufactured and amount approved for distribution. The batch record shall be verified and approved.

Under the following condition, manufacturers shall establish documented requirements for cleanliness of product:
(1) Product is cleaned by the manufacturer prior to sterilization and its use;
(2) Product is supplied non-sterile to be subjected to a cleaning process prior to sterilization and its use;
(3) Product is supplied to be used non-sterile and its cleanliness is of significance in use; or
(4) Process agents are to be removed from product during manufacture.
If product is cleaned in accordance with the preceding Subparagraph 1 or 2, the requirements contained in Subparagraphs 1 and 2 of Article 83 do not apply prior to the cleaning process.

Manufacturers shall establish documented requirements which contain acceptance criteria for installing and verifying the installation of the medical device.
If the agreed customer requirements allow installation to be performed other than by manufacturers or their authorized agents, the manufacturers shall provide documented requirements for installation and verification.
Manufacturers shall maintain records of installation and verification performed by manufacturers or their authorized agents.

Manufacturers shall establish documented procedures, work instructions, and reference materials and reference measurement procedures, as necessary, for performing servicing activities and verifying that they meet the specified requirements.
Records of servicing activities carried out by the manufacturers shall be maintained.

Manufacturers shall maintain records of the process parameters for the sterilization process which was used for each sterilization batch. Sterilization records shall be traceable to each production batch of medical devices.

Any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement, and any processes where deficiencies become apparent only after the product is in use or the service has been delivered, shall be validated by the manufacturers.
The above validation shall demonstrate the ability of these processes to achieve planned results.
Manufacturers shall establish arrangements for these processes, including the following as applicable:
(1) Defined criteria for review and approval of the processes;
(2) Approval of equipment and qualification of personnel;
(3) Use of specific methods and procedures;
(4) Requirements for records; and
(5) Revalidation.
Manufacturers shall establish documented procedures for the validation of the application of computer software, and changes to such software and its application, for production and service provision that affect the ability of the product to conform to specified requirements. Such software applications shall be validated prior to initial use.
Records of the above validation shall be maintained.

Manufacturers shall establish documented procedures for the validation of sterilization processes. Sterilization processes shall be validated prior to initial use.
Records of validation of sterilization process shall be maintained.

Manufacturers shall identify the product by suitable means throughout product realization, and shall establish documented procedures for such product identification.
Manufacturers shall establish documented procedures to ensure that medical devices returned to the manufacturers are identified and distinguished from conforming product.

Manufacturers shall establish documented procedures for traceability. Such procedures shall define the extent of product traceability and the records required.
Where traceability is a requirement, the manufacturers shall control and record the unique identification of the product.

In defining the records required for traceability of active implantable medical devices and implantable medical devices, manufacturers shall include records of all components, materials and work environment conditions, if these could cause the medical device not to satisfy its specified requirements.
Manufacturers shall require that their agents or distributors maintain records of the distribution of active implantable medical devices and implantable medical devices to facilitate the need for traceability and inspection.
Manufacturers shall maintain the name and address of the shipping package consignee of active implantable medical devices and implantable medical devices.

Manufacturers shall identify the product status with respect to monitoring and measurement requirements.
Manufacturers shall maintain the identification of product status throughout production, storage, installation and servicing of the product to ensure that only product that has passed the required inspections and tests, or released under an authorized concession, is dispatched, used or installed.

Manufacturers shall exercise care with customer property while it is under their control or being used by them. Manufacturers shall identify, verify, protect and safeguard customer property provided for use or incorporation into the product. If any customer property is lost, damaged or otherwise found to be unsuitable for use, the manufacturers shall report to the customer and maintain records.

Manufacturers shall establish documented procedures or documented work instructions for preserving the conformity of product during internal processing and delivery to the intended destination.
This preservation shall include identification, handling, packaging, storage and protection. Preservation shall also apply to the constituent parts of a product.
Manufacturers shall establish documented procedures or documented work instructions for the control of product with a limited shelf-life or requiring special storage conditions. Such special storage conditions shall be controlled and recorded

Manufacturers shall determine the monitoring and measurement to be undertaken and the monitoring and measuring devices needed to provide evidence of conformity of product to determined requirements.
Manufacturers shall establish documented procedures to ensure that monitoring and measurement can be carried out and are carried out in a manner that is consistent with the monitoring and measurement requirements.
Where necessary to ensure valid results, measuring equipment shall conform to the following:
(1) Be calibrated or verified at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards; where no such standards exist, the basis used for calibration or verification shall be recorded;
(2) Be adjusted or re-adjusted as necessary;
(3) Be identified to enable the calibration status to be determined;
(4) Be safeguarded from adjustments that would invalidate the measurement result;
(5) Be protected from damage and deterioration during handling, maintenance and storage.
In addition, manufacturers shall assess and record the validity of the previous measuring results when the equipment is found not to conform to requirements. Manufacturers shall take appropriate action on the equipment and any product affected. Records of the results of calibration and verification shall be maintained.
When used in the monitoring and measurement of specified requirements, the ability of computer software to satisfy the intended application shall be confirmed. This shall be undertaken prior to initial use and reconfirmed as necessary.