Title¡G
Regulations of Medical Device Good Distribution Practice CH
Announced Date¡G 2021-04-13
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Article 1
This set of regulations is established pursuant to Article 24 Paragraph 3 of the
Medical Device Act (hereafter referred as the Act).
Article 2
In this Part, regulations related to the storage, distribution, services and
personnel deployment of medical devices and other related operations, are
prescribed with reference to the ISO 13485: Medical Devices ¡X Quality Management
Systems ¡X Requirements for Regulatory Purposes published by the International
Standard Organization.
Article 3
The dealer shall document a medical device good distribution system (the
¡§Distribution System¡¨) and maintain its effectiveness in accordance with the
provisions of these Regulations
The dealer shall determine the processes required for the implementation of the
Distribution System and monitor the implementation of these processes, and shall
establish requirements for activities associated with the Distribution System
and document these activities, in order to ensure the quality of their medical
devices circulation on the market.
The establishment and any changes of the processes described above, shall have
been evaluated for their impact on the implementation of Distribution System and
the medical devices, and have demonstrated conformance to the Act and these
Regulations.
Article 4
The dealer shall make any necessary changes to their Distribution Systems
according to their audit results, data analyses, corrective and preventive
actions, and decisions made by the management review. Upon confirmation, the
said changes shall be implemented, to ensure and maintain the suitability,
adequacy and effectiveness of their Distribution Systems, as well as the safety
and performance of their medical devices.
Article 5
When the dealer outsource to other service provider(s) any activities
related to the import, storage, transportation, sales, protection and/or
provision of services with respect to their products, for those who can affect
the conformity to these Regulations for the Distribution System, there shall be
written agreements between the dealer and such service providers, and the dealer
shall monitor the outsourced activities; the same requirements shall apply when
outsourcing the activity related to the retention of the distribution records.
The dealer shall apply measures to ensure the outsourced activities described
above are in compliance with their written agreements, this Regulations and any
other applicable regulatory requirements.
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Article 6
The Distribution System documentation shall include the following matters:
1. Quality manual or equivalent documentation.
2. Procedures and records required by these Regulations.
3. Documents and records developed by the dealer to ensure the
effectiveness of planning, operation and control of the Distribution System¡¦s
processes.
4. Other documentation required by central competent authorities.
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Article 7
All documents pertaining to the Distribution System shall be controlled.
The dealer shall establish control procedures in written for the following
matters:
1. The documents shall be reviewed, approved, signed/sealed and dated by
personnel before release and circulation; the same applies to the revise.
2. The establishment of the Distribution System documentation master
list.
3. The identification and verification of the version and the history of
revisions and status.
4. The availability of the documents in respective places.
5. The confirmation of document version and readability.
6. Ensuring the validity of the necessary external original documents,
and the control of the distribution of the documents.
7. Prevention of deterioration or loss of documents.
8. Identification of void documents and preventive measures against
misuse.
The dealer shall define the period for which void documents shall be retained.
This period shall ensure that documents pertaining to the distribution of
medical devices are available within the lifetime of the medical devices, which
shall not be less than the validity period specified in the Act.
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Article 8
The dealer shall establish and maintain the Distribution System¡¦s documented
procedures to define the controls needed for the identification, storage,
security, retrieval, disposition and retention period of the records.
The dealer shall formulate and implement protection measures for sensitive
health information in records in accordance with the provisions of the Personal
Data Protection Act.
The retention period of the record in the first paragraph shall be no less than
the validity period of the medical device and shall be no less than three years
from the date of release of the product by the manufacturer. The Act, in which a
longer period is required, shall prevail.
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Article 9
The dealer shall have one person as the management representative for the
Distribution System, who shall be assigned by the top management level.
The duties and responsibility of the preceding paragraph management
representative shall be defined in writing for the following matters:
1. Confirmation of the establishment of the Distribution System process
in writing.
2. Submission to the top management the report on the confirmation of the
effectiveness of the Distribution System and the necessary improvement measures.
3. Promoting and ensuring that the entire team members possess awareness
of applicable regulations and customer requirements, and appropriate ability and
experience, including implementing and maintaining the orientation training and
in-service training programs.
4. Coordinating and performing any recall operations for medical devices.
The management representative shall delegate appropriate person(s) as the
substitute staff or authorized persons to ensure the implementation and
maintenance of the Distribution System, as well as its conformity to this
Regulations.
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Article 10
The dealer shall specify in writing the management level review procedure
for the Distribution System , the content shall include the evaluation for the
changes and improvement of the Distribution System described in Article 11.
The top management level shall review the Distribution System periodically in
accordance with the procedures described in the preceding paragraph, so as to
ensure its adequacy, suitability and effectiveness; its review shall be recorded
and kept on file.
The record mentioned shall include the following matters:
1. Matters reviewed and their content.
2. Necessary improvement measures to maintain the adequacy, suitability
and effectiveness of the Distribution System and its processes.
3. Processes improvement measures based on customer demands
4. Measures to cope with the amendments of laws and regulations.
5. Resource requirements for implementing the three preceding
sub-paragraphs above.
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Article 11
The review as mentioned in the second paragraph of the preceding Article
shall include the following matters:
1. Feedback.
2. The handling customer complaints.
3. Reports to the competent central competent authority.
4. Results of internal or external audits.
5. Monitoring, measurement of the processes and product, and the results.
6. Corrective measures.
7. Preventive measures.
8. Follow-up treatment of the conclusions of the previous review.
9. Changes that may affect the Distribution System.
10. Recommendations for improvement.
11. Measures to cope with the amendments to the law and regulations.
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Article 12
Personnel engaged in work affecting the quality of distribution shall
possess a certain level of skills or experience, or receive appropriate
education and training, to ensure their competency to the work.
The dealer, the establishment of personnel capabilities, the provision of
necessary training and the correct awareness of their responsibilities, shall
establish in writing the procedures for the following matters:
1. Identification of the competence of personnel engaged in work
affecting the quality of distribution, including the release of the product.
2. The provision of necessary training or other measures to maintain
personnel capabilities
3. The training or measures in the preceding sub-paragraphs shall include
the evaluation of their effectiveness and identification of the medical device,
to prevent the defective medical devices into the supply chain.
4. The evidence or records of personnel education, training, and skills
shall be recorded and kept.
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Article 13
The dealer shall specify in writing the conditions of the infrastructure for
the Distribution System to fulfill the requirements of products and to avoid
product confusion and disorderly handling.
The facilities mentioned in the preceding paragraph shall include storage and
operation sites, transportation vehicles, refrigerator/freezer, and equipment
used in the control of the work environment, monitoring and measurement.
The maintenance, validation and calibration of the facility described in the
first paragraph shall be defined in writing with respect to their content,
methods and frequency; records shall be prepared and retained. The content shall
include the following matters:
1. Ensuring vehicles and equipment used to transport, store or handle
medical devices are in compliance with the product specification and
appropriately equipped.
2. An initial temperature mapping and risk assessment exercises shall be
carried out on the storage area before use, and temperature monitoring equipment
shall be positioned according to the results of the assessment.
3. Temperature-sensitive medical devices shall be monitored with
validated equipment; the proof or approval for the use of equipment is produced
and approved by appropriate personnel.
4. Immediate handling procedures of unexpected equipment disorder shall
be established to maintain the quality of medical devices.
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Article 14
The dealer shall specify in writing the requirements on working environment
for the Distribution System ; The temperature, humidity and other external
harmful factors should be considered, and shall be monitored and controlled.
The contents of the preceding paragraph requirements shall include the following
matters:
1. The health, cleanliness and clothing conditions of the personnel who
contact with the product or the operating environment is sufficient to affect
the safety or performance of medical devices.
2. The working environment shall be kept clean to prevent the entry of
insects and animals.
3. The staff¡¦s restrooms, bathrooms and dining areas for employees should
be adequately separated from the storage areas. The storage of food, drink,
cigarettes or medical devices for personal use is prohibited in the storage
areas.
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Article 15
The dealer shall specify in writing the following matters on the
communication with customers for the Distribution System:
1. Product information and distribution requirements.
2. Customer inquiries, and processing and revision of contracts or
orders.
3. Customer feedback including complaints.
4. Advisory notice.
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Article 16
The dealer shall establish written procedures to confirming that the
purchased products meet the users requirements for the Distribution System, so
as to prevent the defective medical devices into the legal supply chain.
The dealer shall establish evaluation and selection criteria for 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 dealer.
2. The supplier¡¦s past performance and regulatory compliance.
The dealer shall plan a mechanism for the monitoring and re-evaluation of the
suppliers. The results of procurement requirements are the reference for
re-evaluation.
The dealer shall return products or take other necessary measures if the dealer
finds that the supplier does not meet the procurement requirements.
The evaluation, selection, monitoring, re-evaluation and necessary measures
mentioned in the first three paragraphs above shall be recorded and kept on
file.
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Article 17
The information required for procurement in the preceding article shall
include the following matters, and be made available for reference in writing or
in other indexable methods:
1. Product specifications.
2. Product acceptance, procedures, processes and equipment.
3. The requirements for qualification of supplier.
4. The Distribution System fulfills the requirements in this Regulations.
The dealer shall determine the adequacy of purchasing requirements before
contacting suppliers. The dealer, when necessary, shall have an agreement in
writing that the supplier shall notify the dealer in advance before implementing
the changes that may affect purchasing requirements.
The dealer shall maintain documents and records of purchasing information
required for traceability as set forth in Article 18 with respect to
traceability requirements.
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Article 18
The dealer shall establish written traceability procedures specific for the
source and flow of products in the Distribution System, the content includes the
scope and records of product traceability.
The preceding records shall include the name of the medical device, batch/lot
number, date and quantity received, expiration date, name of supplier, name,
address and contact person of the consignee, delivery address, shipping methods
and temperature conditions applicable for acceptance. For those that are to be
delivered by parcel, the record of the voucher of the name and address of the
consignee shall be kept.
The records described in the first paragraph should be kept.
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Article 19
The dealer shall establish written protection procedures with product
requirements for the Distribution System, so as to ensure product quality
remains unaffected during storage, handling, and transportation processes.
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 dealer shall implement the
following matters:
1. Providing 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.
3. Receipt and dispatch areas have appropriate measures in place to
protect medical devices from being affected by weather conditions.
4. Having adequate separation between the receipt and dispatch and
storage areas; and medical devices that are with a short expiry date or shelf
life shall be removed immediately from saleable stock.
5. Medical devices shall not store directly on the floor.
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Article 20
The dealer shall establish written procedures the monitoring and measurement
operations to fully certify the product conformity for the Distribution System,
and shall have the relevant equipment necessary to perform the operations.
The use of the measuring equipment mentioned in the preceding paragraph shall
comply with the following requirements:
1. Calibration or verification with clear international or national
measurement standards before use; where there are no such 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 makes 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.
5. Establish validation procedures 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.
6. The procedures for computer software failures, crashes, repairs and
data backups of the preceding sub-paragraph shall be regulated.
The dealer shall perform the calibration or verification or adjustment in
accordance with the first paragraph, record and keep on file.
The equipment in the first paragraph is non-conformity in accordance with the
provisions in the second paragraph, the dealer shall evaluate the effectiveness
of the measurement of its output and record it. Appropriate measures shall be
taken for the affected products.
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Article 21
The dealer shall establish written procedures specific for the information
collection and methods used for the conformity of customer requirements in the
Distribution System, the content should include the compilation of information
on the distribution activities, and the evaluation of the effectiveness of the
Distribution System.
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Article 22
Except for legitimate reasons, the dealer shall investigate customer
complaints to find out whether it caused by medical device quality or
distribution, and shall, the dealer shall provide the investigational results or
improvement measure taken to relevant agencies or institutions case by case.
The content of the complaint in the preceding paragraph, the investigation
process, results, and the object provided or the improvement measures taken,
shall be recorded and kept on file.
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Article 23
The dealer shall handle the reporting of adverse events of paragraph 1 of
Article 48 of the Act, the reporting and the undertaking of corrective and
preventive measures of Article 49 of the Act, the notifying and recalling within
a definite time of Paragraph 1 of Article 58 of the Act, and formulate the
procedures for operation, and the effectiveness of medical devices recall
operations should be evaluated annually.
The notification, corrective and preventive measures, recall as mentioned in the
preceding paragraph shall be recorded and kept on file.
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Article 24
The dealer shall conduct internal audits regularly to ensure the
effectiveness of the quality management system and its compliance with laws and
regulations.
The dealer shall establish written procedures for the audit as mentioned in the
preceding paragraph, which shall include the following matters:
1. The responsibilities and requirements for planning, conducting and
recording audits, and reporting audit results.
2. Taking into account the subject, content and location, as well as the
relative importance of the processes in the Distribution System and the results
of previous audits, and establish an audit plan.
3. The audit criteria, scope, frequency, method and records; the auditor
shall not audit the work of their own duties.
The management of the auditee shall propose corrective measures for the
non-compliance of the audit results as mentioned in the first paragraph and
correct them in time to ensure that the non-compliances and their causes are
removed.
Auditors shall submit verification reports on the content and results of the
implementation of corrective measures.
The process, place and results in the first paragraph of the audit shall be
thoroughly recorded and kept on file.
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Article 25
The dealer shall identify and control products that do not meet the
requirements to prevent unintended use or delivery.
In order to meet the requirements of the preceding paragraph, the dealer shall
establish written procedures to define the controls and responsibilities for the
identification, recording, segregation, evaluation and disposition. of the
products that do not meet the requirements of the original manufacturer.
The dealer shall record the non-conformity as mentioned in the first paragraph,
the subsequent evaluation and investigation, and reasons for decisions made, and
keep the record on file.
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Article 26
The dealer shall impose the following actions separately or simultaneously
on substandard products mentioned in the preceding Article:
1. Actions to remove non-conformities.
2. Actions to prevent the use or application of substandard products
mistakenly for their intended purposes.
3. Authorization of the use, release or acceptance of the product under
concession.
The dealer could adopt the actions in the third sub-paragraph of the preceding
paragraph only with sufficient valid reasons, meets applicable regulatory
requirements, and receive the approval of the responsible personnel. The name
and title of the person giving the approval shall be recorded and kept on file.
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Article 27
After the product is released, it is found that there is a product that does
not meet the requirements of the preceding Article, the dealer shall take
appropriate measures with regard to its impact or potential impact, and shall be
recorded and kept on file.
The dealer shall specify in writing issuing procedures for implementing advisory
notices in accordance with the requirements of manufacturers.
Returned products should be separated from a qualified product. The product
integrity can be proved by the evaluation of the original manufacturer or its
authorized person, and the product can be accepted and re-released after
approval by the authorized person. The name and title of the personnel approving
the acceptance and release shall be recorded and kept.
Products of acceptance and re-release in the preceding paragraph shall be placed
in accordance with the ¡¥first expired first out¡¦ (FEFO) principle, to ensure
correct medical devices with appropriate shelf life can be selected. In special
circumstances where such requirements cannot be followed, it shall be recorded.
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Article 28
The dealer shall take corrective actions to remove the cause of
non-conformity in products or the Distribution System to prevent its recurrence.
The implementation of the corrective actions mentioned in the preceding
paragraph shall not be delayed for no reason, and the content of the actions
shall be based on the degree of impact of the non-conformity.
In order to implement the corrective action mentioned in the first paragraph,
the dealer shall establish written procedures for the following matters:
1. Review of non-conformities including customer complaints.
2. Judgment of causes of non-conformities.
3. Evaluation of the adoption of corrective actions.
4. The planning, establishment and implementation of corrective actions,
and the necessary updating of the Distribution System documents.
5. Verification that corrective actions do not conflict with laws and
regulations, and do not degrade the safety and performance of the medical
device.
6. Review of the implementation of corrective actions and their
effectiveness.
The dealer shall record and keep on file the results of investigations of
non-conformities as defined in the first paragraph and the implementation of
corrective actions.
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Article 29
The dealer shall take preventive actions to remove possible causes of
potential non-conformity in products or the Distribution System to prevent its
occurrence.
The preceding content of the preventive actions shall be based on the degree of
impact of potential non-conformities.
In order to implement the preventive actions in the first paragraph, the dealer
shall establish written procedures for the following matters:
1. Judgment of potential non-conformities and their possible causes.
2. Evaluation of the adoption of preventive actions.
3. The planning, establishment and implementation of preventive actions,
and the necessary updating of the Distribution System documents.
4. Verification that the preventive actions do not in conflict with laws
and regulations, and do not degrade the safety and performance of medical
equipment.
5. Review of the implementation of preventive actions and their
effectiveness.
The dealer shall record and keep on file the results of investigations of
potential non-conformities as defined in the first paragraph and the
implementation of preventive actions.
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Article 30
The Regulations shall be implemented from May 1st, 2021.