The manufacturer shall specify in writing the risk management process necessary for product realization.
The manufacturer shall plan and establish the processes required for product realization, and the plans shall comply with other process requirements of the quality management system.
The content of the aforementioned planning shall be done in writing and specified in the format acceptable with the operation mode of the manufacturer.The content of planning shall include the following items, as appropriate:
1. Quality objectives and product requirements;
2. The establishment of necessary processes and documents, and the provision of specific resources by individual products including the infrastructure and working environment;
3. The verification, validation, monitoring, measurement, inspection, testing, handling, storage, distribution and source tracing measures of individual products, and their acceptance criteria;
4. Records sufficient to prove that both the product realization process and the final product meet the requirements.
The implementation of risk management mentioned in the first paragraph shall be recorded and kept on file.

The manufacturer shall confirm the following matters:
1. Requirement specified by the customers, which scope covers both before and after delivery;
2. To meet known regulations or intended uses;
3. Applicable laws and regulations of the products;
4. The necessary training to be received by the users in order to ensure that the use of medical devices meets the expected performance and safety;
5. Other matters.

Before accepting product orders, the manufacturer shall review the requirements related to the products and complete the confirmation of the following matters:
1. Specified requirements on products:
2. Handling of the difference between the content of the contract or order and that as previously specified;
3. The compliance of laws and regulations;
4. Provision of user training courses;
5. The manufacturer’ possession of the ability to meet various requirements.
The results of the review and the measures to be taken related to the foregoing review shall be recorded and kept on file.
If the customer does not state the requirement in writing, the manufacturer shall ascertain it before accepting the order.
If there are changes occurring in the agreement between the manufacturer and the customer, the manufacturer shall revise the relevant documents and inform its relevant personnel of the changes.

The manufacturer shall specify in writing the following matters on the communication with customers;
1. Product information;
2. Customer inquiries, and processing and revision of contracts or orders;
3. Customer feedback including complaints;
4. Advisory notice.
The manufacturer shall apply for, notify or report matters specified in laws and regulations to the competent authority.

The manufacturer shall specify in writing the procedures and requirements for product design and development. The content shall include the following:
1. The schedule of design and development, and the review, verification, validation and design transfer measures as implemented in each phase.
2. The duties and functions of the staffs at each phase of the procedure;
3. The method of tracing the design, development and output to its original items of input;
4.The resources required for product realization, including the necessary capabilities of the personnel.
The written documents mentioned in the preceding paragraph shall be kept on file and updated in due course.

The manufacturer shall review the appropriateness of the design and development input items of the following matters, and verify, record and maintain the same:
1. The functions, features, usability and safety based on the intended use;
2. Applicable legal requirements and standards;
3. Output of applicable risk management assessment and measures resulted from research;
4. Information available from similar product designs;
5. Other basic requirements for product and product realization process design and development.
The matters in the preceding paragraphs shall be clear, complete and reasonable, and shall be presented with methods for verification or validation.

The product design, development and output shall comply with the following:
1. Conformity with the content approved in the first paragraph of the preceding Article and shall be presented with methods of verification;
2. Provision of necessary information for the procurement, production and service;
3. Specification of the acceptance criteria of products;
4. Specification of the product characteristics that are essential for the product safe and proper use.
The output mentioned in the preceding paragraph shall be subject to approval before being released; its records shall be kept on file.

The manufacturer shall meet Article 35 of the Act. to perform review on the design and development based on the plans in writing to complete the following matters:
1. Evaluation of the compliance of the results of design and development with requirement;
2. Identification and proposal of necessary actions.
Participants in the foregoing review shall include representatives of the design and development departments, representatives of the departments affected by the design and development results, and other technical personnel.
The results of the review and the necessary measures indicated therewith shall be recorded and kept on file.
The content of the record as mentioned in the preceding paragraph shall clearly record the subject of the review, the staff conducting the review and the date of review.

In order to ensure the consistency of design, development input and output, the manufacturer shall specify in writing its consistency verification plan and implement it accordingly.
The content of the foregoing plan shall include the verification methods, acceptance criteria, necessary statistical techniques with rationale for sample size.
The verification mentioned in the first paragraph shall include the requirement of connection or interface conforming with input and output consistency when and if the intended use of the product involves the connection or interface with other medical devices.
The verification results, conclusions and necessary measures proposed at the end of the verification shall be recorded and kept on file.

In order to ensure that the final product designed and developed meets the specific application or expected requirements, the manufacturer shall establish in writing a validation plan, which includes the validation methods, acceptance criteria, and the necessary statistical techniques with rationale for sample size.
The subject of validation in the preceding paragraph shall be selected from representative products such as the first batch of production, and the reasons for selection shall be recorded and kept on file.
The validation mentioned in the first paragraph shall include the requirement of specific application or expected requirements when and if the intended use of the product involves the connection or interface with other medical devices.
The validation mentioned in the first paragraph shall be completed before the product is released. The verification result and the necessary measures proposed shall be recorded and kept on file.

The manufacturer shall specify in writing the procedures for the transfer and application of the design and development results to actual manufacturing, to ensure that the manufacturing process and production capacity have been verified to meet the requirements. The process and content of the transfer shall be recorded and kept on file.

The manufacturer shall specify in writing the control procedures on the changes of the design and development to determine the degree of impact of the changes on the functions, performance, usability, safety, regulatory requirements and intended use of the medical devices.
The control mentioned in the preceding paragraph regarding the content of the change shall be exercised in review, verification, necessary validation, approval and be completed before the change takes place.
The review mentioned in the preceding paragraph shall include an assessment of the impact of changes on product components, products in process or delivered, risk management input or output, and the process of product realization.
The results of changes, the review and its related necessary measures shall be recorded and and kept on file.

The manufacturer should, for the design and development of each model or series of medical devices, establish and maintain a file.
The foregoing file shall include or provide an index to records that can prove compliance with the design and development requirements and the changes on the design and development.

The manufacturer shall establish in writing a validation procedure to ensure that the purchased products meet its requirements.
The manufacturer shall formulate evaluation and selection criteria on the suppliers. These are to be set based on the following considerations:
1. The ability of the supplier to provide products that meet the specifications of the manufacturer;
2. The supplier's past performance;
3. The degree of influence of the products provided by suppliers on the quality of medical devices;
4. Risks of medical devices to be manufactured.
The manufacturer shall plan mechanisms for the monitoring and re-evaluation of the suppliers. The results of purchasing requirement compliance control are to be used as a reference for re-evaluation.
The manufacturer shall take necessary measures if it finds that the supplier does not meet the purchasing requirements.
The evaluation, selection, monitoring, re-evaluation and necessary measures mentioned in the first three items above shall be recorded and kept on file.

The purchasing requirements mentioned in the preceding article shall include the following matters and be made available for reference in writing or by other index methods:
1. Product specifications;
2. Product acceptance, procedures, processes and equipment;
3. Qualification of supplier personnel;
4. Quality management system.
The manufacturer shall determine the adequacy of purchasing requirements before approaching suppliers.The manufacturer, when necessary, shall enter into agreement in writing that the supplier shall notify the manufacturer in advance before implementing the changes that may affect purchasing requirements.
The manufacturer shall maintain documents and records of purchasing information required for traceability as set forth in these Regulations.

The manufacturer shall formulate and implement inspections or other necessary verification measures to ensure that the purchased products meet the purchasing requirements.
The selection of the measures and content of the preceding paragraph shall refer to the results of the risk assessment of the supplier and the medical device to be manufactured.
If there is a change in the purchased product, the manufacturer shall determine the impact of the change on the medical device or its manufacturing process.
The measures mentioned in the first paragraph which can be implemented by the manufacturer or its customers at the supplier's premises, shall be stated in the purchasing information mentioned in the preceding Article, with the implementation measures and the method of product release specified.
The implementation of the measures mentioned in the first paragraph shall be recorded and and kept on file.

The manufacturer shall plan the production and service processes, and implement, monitor and control them to ensure that products meet specifications.
The content of production control in the preceding paragraph shall include, as appropriate, the following matters:
1. Control procedures and methods for production stated in writing;
2. Validation of the suitability of infrastructure;
3. Implementation of monitoring and measurement on process parameters and product characteristics;
4. Confirmation of the integrity of the equipment implementing the monitoring and measurement stated in the preceding subparagraph;
5. Implementation of labeling and packaging operations.
6. Implementation of product release, delivery and post-delivery activities.
The manufacturer shall establish and maintain a production control record for each batch (piece) of medical devices, and the content of which shall include the scope of traceability set out in these Regulations, as well as the amount of production and distribution. The record shall be verified and approved.

The manufacturer, under any of the following circumstances, shall formulate in writing the requirements for product cleaning or pollution control:
1. The product shall be cleaned by the manufacturer before sterilization or use.
2. The product is supplied in a non-sterilized state, but the cleaning process is completed before sterilization or use.
3. The product cannot be cleaned before sterilization or use, but its cleanliness has a significant impact on use.
4. The product does not need to be sterilized for use, but its cleanliness has a significant impact on use.
5. The pharmaceuticals used in the manufacturing process must be removed from the product.
Subparagraphs 1 and 2 of the preceding paragraph do not apply the provisions of Article 29 before cleaning.

The manufacturer should, when necessary, formulate in writing the verifiable installation requirements and acceptance criteria for specific medical devices.
If, upon the request of the buyer, the manufacturer agrees for the medical device to be installed by a third party other than the buyer and its authorized agent, the manufacturer shall provide to the third party the documents of the matters and criteria set out in the preceding paragraph.
The manufacturer shall record and maintain the records of the installation by itself or its authorized agents.

If there are specific specifications for the after-sales service of medical devices, the manufacturer shall formulate, in writing, the service procedures, the reference measurement methods or other information for implementation and verification.
For the aforementioned service, the manufacturer or its authorized agent shall record and keep it on file.
The manufacturer shall analyze the foregoing records to determine whether there are any complaints that shall be handled, and if necessary, include them in the reference for product improvement.

The manufacturer shall keep a record of the sterilization process parameters of each sterilization batch.
The content of the foregoing record shall be traceable to each production batch of the medical device.

The deficiencies of production or service of medical devices, which cannot be revealed without being used or received, shall be validated by the manufacturer of the process of production or service.
The procedure of validation mentioned in the preceding paragraph to prove that the production or service is in accordance with its planned schedule shall be set it in writing, and its content includes the following matters:
1. Review standards and approval procedures;
2. The required equipment and their specifications, and the qualifications of the implementing personnel;
3. Specific methods, procedures and acceptance criteria adopted;
4. The statistical techniques with rationale for sample size;
5. The requirements for record confirmation in accordance with Article 13;
6. Revalidation and its criteria;
7. Approval of changes of the validation procedures;
The manufacturer shall establish procedures in writing to validate the computer software they use before production or service provision; the same applies to changes adopted in their software. The choice of software validation and revalidation methods shall take into account the impact of software on product specification compliance.
The results of the foregoing validation and revalidation, the conclusions obtained based on the results, and necessary actions for subsequent implementation shall be recorded and kept on file.

The manufacturer shall establish in writing the procedures for validation of the sterilization process and the sterile barrier system. The scope of application includes the product itself, and the same applies when the manufacturing process is changed.
The results of validation mentioned in the preceding paragraph, their conclusions and the necessary follow-up measures shall be recorded and kept on file.

The manufacturer shall establish in writing the procedures and methods for identifying products in the product realization process to ensure that the returned product is separated from other products.
The manufacturer shall identify product compliance during the process of product realization. The process includes production, storage, installation, and service processes so as to ensure that only products that pass specific inspections, tests, or approvals are released, used, or installed.
The manufacturer shall establish in writing a single identification system for medical devices with certain risk class as announced in accordance with the first paragraph, Article 19 of the Act .

The manufacturer should, within the scope and record content stipulated by laws and regulations, set in writing the traceability procedures of products.

Where the record mentioned in the preceding Article relates to traceability of implantable medical devices, it shall include all parts, materials and production environmental conditions that may cause non-compliance with safety and performance requirements.
The manufacturer of the product mentioned in the preceding paragraph shall require the logistics and distributor of its product to keep the logistic or sales records; and whereas the product is delivered by parcel, the record of the voucher of the name and address of the consignee shall be kept by the manufacturer.

The manufacturer shall identify, verify, protect and safeguard the tools, storage equipment, transportation vehicles, development designs, materials, or other tangible or intangible assets provided by the customer for use or forming part of the product.
If the asset in the preceding paragraph is lost, damaged or unusable, the manufacturer shall notify the customer and produce a record and keep on file.

The manufacturer shall establish in writing protection procedures to ensure that the product specifications are not affected by the processing, storage, handling and distribution process.
In the procedures mentioned in the preceding paragraph, in order to prevent the product from being exposed to the anticipated state or hazard, which lead to the risks of alteration, contamination or damage, the manufacturer shall implement the following matters:
1. Designing and constructing suitable packaging and shipping containers.
2. Providing special additional conditions in writing, if the package or container in the preceding subparagraph fails to provide adequate protection under specific circumstances, and the conditions shall be under control and listed in records.
The above two provisions also apply to the protection of product components.

The manufacturer shall plan the monitoring and measurement operations to fully certify the product conformity and shall have the relevant equipment necessary to perform the operations.
The procedure mentioned in the preceding paragraph shall be specified in writing by the manufacturer.
The use of the measurement equipment mentioned in the first paragraph shall comply with the following requirements:
1. Calibration or verification with clear international or national measurement standards before initial use; where there are no clear standards, the basis used for calibration or verification shall be recorded. The same shall be done regularly after the equipment is commissioned;
2. After calibration and verification, it make necessary adjustments and readjustments for avoiding adjustments that cause invalidated measurement results;
3. The calibration status shall be identified;
4. Taking precautionary measures to avoid damage or deterioration in case of handling, maintenance or storage.
The manufacturer shall perform the calibration or verification in accordance with the provision of the second paragraph, and record and keep the results.
If inconformity is found on the equipment as mentioned in the first paragraph, the manufacturer shall evaluate the effectiveness of the measurement of its output and record it. Appropriate measures shall be taken for the affected products.
The manufacturer shall establish in writing a validation procedure for the suitability of the computer software for monitoring and measurement purposes, and complete the confirmation before the software is used, or after actual use, or upon changes made in the software.
The validation and re-validation of the software mentioned in the preceding paragraph shall be based on the risks of using the software and exercised with appropriate methods and activities. The results, conclusions reached and necessary follow-up actions shall be recorded and kept on file.
The risks mentioned in the preceding paragraph include the effects of the capability of the medical device to meet its intended use.