GN-09 — Guidance Notes GN-09 - Guidance Notes for Listing of Distributors of Medical Devices
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Edition
Number
Date of
Revision
Summary of Revision Reference
Number
0 30 April 2015 First issue of GN-09 GN-09:2015(E)
1.0 19 April 2021
Revised Clause 1 - Introduction.
Added Clause 2 - Scope
Revised the definition of Distributor
and Documented Procedure in
Clause 3 - Definition
Merged Clause 4 and 6 in Edition
Number 0 into Clause 4 –
Application procedures
Revised the requirements for
premises in Clause 5 –
Requirements for listing of
distributors
Added Appendix I for the guidance
on requirements for listing of
distributors
GN-09:2021 (E)
2 2 April 2024
“Make” is replaced with
“Manufacturer”
Update document format
GN-09:2024 (E)
3 14 June 2024
Clause 4.1, 4.2, 4.3 and 4.4 are
revised
GN-09:2024-1(E)
4 8 August 2024
Clause 6.6 to 6.4 are revised
(Appeal)
Clause 6.5 is added
Update document format
GN-09:2024-2(E)
5 31 December
2025
Clause 6.2 (Renewal of listing) is
added
Clause 6.1.1 is revised
GN-09:2025(E)
Edition
Number
Date of
Revision
Summary of Revision Reference
Number
6 1 September
2026
Clause 4.5, 5.2.2, 5.11.1, 6.7.1
6.7.4 and Appendix I are revised
Clause 4.2.2, 4.2.3, 4.9
(Notification of approval or
rejection of application) and 7
(Compliance with the Prevention
of Bribery Ordinance) are added
GN-09:2026(E) (Ed. 6) — official PDF page 2; original table columns, symbols and diagram connectionsGN-09:2026(E) (Ed. 6) — official PDF page 3; original table columns, symbols and diagram connections
1. Introduction 1.1 This document provides general guidance to applicants applying for listing as distributors under the Medical Device Administrative Control System (MDACS). 1.2 Recognising the importance of distributors in the medical device supply chain and medical device post-market phase, the Medical Device Division (MDD) maintains a List of Distributors under the MDACS. 1.3 Application for listing as a distributor is entirely on a voluntary basis.
2. Scope 2.1 Distributors of medical devices may apply to be included on the List of Distributors if they distribute any of the medical devices in Hong Kong.
3. Definitions 3.1 For the purposes of this document, the following definitions and those given in the Guidance Notes issued by the Medical Device Division (MDD) are applicable: 3.1.1 Distributor means any legal person (other than a manufacturer, an importer or a retailer) in the supply chain who carries on business of distributing medical devices in Hong Kong either on his own behalf or to another distributor. Notes: The following are exempted from the scope of listing as distributors: (a) A person who purchases or receives medical device(s) exclusively for one’s own personal use; (b) Retailer who supplies a medical device, or provides a service utilising a medical device, solely and directly to the end user; (c) Health care facility or provider that provides diagnostic or therapeutic services to patient(s) or individual(s); (d) A business party which purchases or receives medical device(s) solely for use by its employees during work activities (e.g. first aid kits and disposable gloves) or for incidental emergency use as long as one is not in the business of offering healthcare service(s) to employees or other individuals; and 2 / 23 GN-09:2026(E) (e) A person in the supply chain involves in activities such as storage and transport of medical devices on behalf of the manufacturer, importer, distributor or Local Responsible Person (LRP). 3.2 Documented procedure means standard operating procedure (SOP) that requires to be established, implemented and maintained.
4. Application procedures 4.1 The applicants for listing as distributors are required to complete the application form MD-IP+D through the online Medical Device Information System (MDIS) (https://mdis.mdd.gov.hk/) together with the following documents: 4.1.1 A copy of business registration certificate in Hong Kong; and 4.1.2 A copy of documented procedures as specified in Clauses 5.3 - 5.9; or a copy of ISO 13485 or ISO 9001 certificate for their business covering the documented procedures as specific in Clauses 5.3 - 5.9 and a copy of the quality manual.
4.2 Submission of applications 4.2.1 An application for listing of distributor must be made with the application form MD- IP+D through the online Medical Device Information System (MDIS) (https://mdis.mdd.gov.hk/). 4.2.2 All submitted certificates shall remain valid at the time of application. Should a certificate expire during the assessment period, a renewed and valid certificate shall be submitted upon request to ensure uninterrupted processing. Submission of an electronic certificate is considered sufficient if the electronic certificate contains a valid and verifiable electronic signature of an authorized person of the issuing organization/regulatory authority, and its authenticity could be verified via the designated official website of the issuing organization/regulatory authority. For other electronic documents, the submission is considered sufficient if the electronic document contains a valid and verifiable electronic signature of an authorized person of the issuing company under the company domain completed with time- stamp. 4.2.3 In instances where the authenticity and/or accuracy of a certificate or document submitted is in question, a certified copy may be required for verification (such as 3 / 23 GN-09:2026(E) purported scanned copy of an original certificate or document). Such certification shall be performed by an authorised body or a qualified personnel. The MDD reserves the right to request additional information regarding the qualification of the certifying entity to ensure the validity of the certification. The MDD reserves the right to verify authenticity and/or accuracy of a certificate or document direct with the issuing organization/ regulatory authority.
4.3 Acknowledgement of application 4.3.1 On receiving an application, the MDIS will send an acknowledgement receipt to the applicant’s registered email. If an applicant does not receive any acknowledgement receipt within two (2) weeks after submitting an application, he/she may contact the MDD to check if the submission has been received by the MDD.
4.4 Submission of documented procedures The documented procedures stipulated in Clauses 5.3 - 5.9 are considered essential for the evaluation of an application. The listed distributor should establish its own procedures taking account of the workflow, operations, nature of medical devices, reporting and follow up requirements, organisation structure and needs of its own organisation. If necessary, the applicant may be requested to provide documentary evidence such as relevant documents/agreements signed with the LRPs/manufacturers/importers on the role and arrangement for the establishment and implementation of such documented procedures. 4.5 Each application for listing as a distributor will be subject to processing and vetting by the MDD before it is considered by the Distributor Listing Approval Board. . 4.6 The processing of an application will include, but not limited to, the checking of the submitted application for adequacy and accuracy of the information and supporting documents provided by the applicant. Where necessary, the MDD may request the applicant to provide supplementary information or additional documents in support of its application. 4.7 The MDD will only proceed with the application if, and only if, the “Undertaking by Applicant” in the application form has been duly completed and signed by or on 4 / 23 GN-09:2026(E) behalf of the applicant. 4.8 The processing and approval of an application will normally be completed within twelve (12) weeks, provided that a properly completed application form (which must include inter alia a duly completed and signed “Undertaking by Applicant”), together with all the necessary supporting documents, have reached the MDD.
4.9. Notification of approval or rejection of application
4.9 Notification of approval or rejection of application 4.9.1 An application for inclusion on the List of Distributors may either be rejected, approved, or approved conditionally. If the application is approved or conditionally approved, a listing number will be assigned to the distributor. The applicant will be notified of the rejection, approval, or conditional approval, along with any listing number assigned (in the case of approval or conditional approval), by letter. Where the application is approved conditionally, this letter will also specify the special conditions on which the approval is given. Failure of the distributor to comply with those conditions may result in their removal from the List of Distributors.
5.1.1. The distributors shall have properly manned premise(s) in Hong Kong where
5.1.1 The distributors shall have properly manned premise(s) in Hong Kong where distribution of medical device(s) are carried out. Where appropriate, premises should include, but not limited to, office, receiving area, storeroom, medical device maintenance area (if any) and dispatching area. 5.1.2 Actions should be taken to prevent unauthorized persons from entering the premise(s). 5.1.3 Storeroom should be of sufficient capacity to allow the orderly storage of the various categories of medical devices. 5.1.4 Storeroom should be clean, and free from accumulated waste and vermin. Cleaning records should be kept. There should be pest control measures to prevent pest infestation. Records of any pest control measures taken shall be kept. There should be appropriate programme for the clean-up of any spillage to ensure complete removal of any risk of contamination. 5.1.5 Storage conditions for medical devices should be in compliance with the instructions on the label. 5 / 23 GN-09:2026(E)
5.1.6. Recorded temperature and appropriate humidity monitoring data should be
5.1.6 Recorded temperature and appropriate humidity monitoring data should be available for review and inspection. The equipment used for monitoring should be checked at suitable predetermined intervals and the results of such checks should be recorded and retained. 5.1.7 Equipment used for monitoring of storage conditions or measuring equipment used for determining of product quality should be calibrated and maintained at defined intervals. Relevant records should be kept.
5.2.1. The distributors are required to have documented procedures to cope with
5.2.1 The distributors are required to have documented procedures to cope with distribution and post-market activities. Distributors are encouraged to implement quality management systems covering the full scope of their operations that are related to the MDACS. The documented procedure should be in conjunction with the respective Local Responsible Persons (LRPs), or manufacturers if there is no LRP. 5.2.2 Records shall be established and maintained to provide evidence of conformity to the requirements and the effective implementation of the procedures. The listed distributor shall document the procedures to define the controls needed for the identification, storage, security and integrity, retention time and disposition of records. The listed distributor shall also retain the records for a period of time not less than the projected service life of the medical device as defined by the manufacturer, or at least seven (7) years from the date of medical device distribution, whichever is longer. 5.2.3 All operation procedures and records related to the handling and control of medical devices shall be reviewed regularly and documented. In the event of irregularities and/or deficiencies found in the operation procedures and record keeping, the causes of irregularities and/or deficiencies shall be investigated and corrective and/or preventive actions shall be taken and documented.
5.3 Keeping of supply records 5.3.1 The distributor shall have documented procedures for keeping of supply records and maintain an updated list of all the medical devices distributed. The supply records should include the manufacturer, model, batch number, serial number, quantity of medical devices, as appropriate. Such records should contain sufficient 6 / 23 GN-09:2026(E) information to trace the distributed medical device(s) and to permit a prompt and complete withdrawal of the device(s) from the market when needed.
5.4. Handling, storage and delivery of medical devices
5.4 Handling, storage and delivery of medical devices 5.4.1 The distributor shall have documented procedures in handling, storage and delivery of medical devices to fulfill the following requirements: (a) Protection from environmental conditions that may affect the safety or performance of medical devices; (b) Identification and appropriate storage, handling and delivery of medical devices that require special storage or transport conditions, for instance IVD medical device that requiring cold chain management; (c) Stock rotation (first-expiry first-out) for medical devices that have a limited shelf-life or expiry date; (d) Proper handling of medical devices to prevent damage, deterioration or contamination; (e) Identification, segregation and control of nonconforming, returned or recalled medical devices to prevent them from being inadvertently sold/issued; (f) Adequate and sufficient incoming and outgoing inspection to ascertain the safety, performance and quality of the medical devices received and to be issued; (g) Periodic stock reconciliation should be performed by comparing the actual and recorded stocks, all significant stock discrepancies should be investigated to checked that there have been no advertent mix-ups, incorrect issue and/or misappropriation of medical devices; and (h) Delivery procedures, including verification of orders and physical inspection of label description, type and quantity of medical devices to avoid incorrect medical devices from being delivered/received.
5.5. Management of product recalls and field safety notices
5.5 Management of product recalls and field safety notices 5.5.1 The distributor shall have documented procedures to manage product recalls and field safety notices (that including field safety corrective actions, product recall, product modification, etc.). The procedure should describe how the distributor manages or assists in managing product safety alerts that issued by MDD or other overseas authorities, and field safety notices/advisory notices that issued by the 7 / 23 GN-09:2026(E) manufacturers, importers or LRPs.
5.6. Managing reportable adverse events in Hong Kong
5.6 Managing reportable adverse events in Hong Kong 5.6.1 The distributor shall have documented procedures to manage reportable or potential reportable adverse events as defined in Guidance Notes GN-00 (Definitions and Abbreviations for Medical Device Administrative Control System) involving any of the medical devices which have come to the attention of the distributor. The listed distributor should seek the consent of the reporting party for referring the reportable adverse event to the LRP (the manufacturer and the MDD if there is no LRP). If the reporting party does not consent, the listed distributor should ask the reporting party to report the adverse event directly to the LRP (or the manufacturer and the MDD if there is no LRP). 5.6.2 The Guidance Notes GN-03 (Guidance Notes for Adverse Event Reporting by Local Responsible Persons) provides details about reporting adverse events. Where applicable, the listed distributor shall work closely with the LRP (the manufacturer and the MDD if there is no LRP) and render all necessary assistance to the LRP and/or manufacturer in reporting any reportable adverse event related to a medical device particularly if the device in found on the supply records.
5.7 Complaints handling 5.7.1 The distributor shall establish a documented procedure in handling complaints related to any of the imported medical devices. The procedure shall include, but not limited to, the following key activities (a) Receiving and evaluating information to determine if the feedback constitutes a complaint; (b) Investigating complaints; (c) Reporting to regulatory authorities as appropriate; (d) Handling of complaint related devices; (e) Determining and initiating corrections and/or preventive actions on the basis of risk; and (f) Defining requirements for complaint records.
5.8 Tracking of specific medical devices 5.8.1 The distributor shall have documented procedures to track the high-risk devices 8 / 23 GN-09:2026(E) specified in ‘List of Medical Devices Requiring Tracking’ in Guidance Notes GN-01 (Overview of the Medical Device Administrative Control System) down to patient or user-facility level and pass all necessary information to the LRP.
5.9 Maintenance and services arrangements 5.9.1 The distributor shall establish a documented procedure in providing preventive and corrective maintenance services to the medical devices, including calibration, provision of spare parts and other maintenance services.
5.10 List of medical device distributed 5.10.1 In addition to the application form and documented procedures stipulated above, the applicant shall also submit a list of medical devices being distributed by him/her. The list shall contain key information of each medical device including manufacturer, model, device description, storage conditions, and MDACS listing number (if applicable).
5.11 Reporting changes 5.11.1 The listed distributor shall submit Change Application Form for Listed Distributor through the online Medical Device Information System (MDIS) (https://mdis.mdd.gov.hk/) to notify the MDD as soon as possible but no later than four (4) weeks after changes made to the information submitted such as contact details and distributor particulars. The MDD has the discretion to request the listed distributor to produce documentary evidence of the change within two (2) weeks.
5.12 Requirements for inspections 5.12.1 Upon request by the MDD during the application stage or after the application is approved, the applicant / listed distributor shall: (a) Make available to the MDD for inspections, as soon as possible, the supply records, documented procedures and other requested documents maintained by them; and (b) Allow the MDD to perform inspections of the applicant’s / listed distributor’s premises where distribution operations are carried out as well as any related storage and/or transportation facilities. The applicant / listed distributor must make provision for such inspections and provide all the necessary assistance 9 / 23 GN-09:2026(E) to the MDD to facilitate the conduction of the inspections.
5.13. Responsibilities in respect of advertisements
5.13 Responsibilities in respect of advertisements 5.13.1 The distributor shall not publish or cause to be published any advertisements or other commercial promotional materials that contravene applicable ordinances such as the Undesirable Medical Advertisement Ordinance (Cap. 231). 5.13.2 Where any document, statement, information, claim, advertisement, promotional material (or any other communication by any means) published to the public, customers or potential customers includes any representation that the distributor is a listed Distributor, or that the distributor is in compliance with the MDACS requirements on listed Distributor, it shall at the same time include a statement to the effect that: (a) The listing of a Distributor carries no implication that its medical devices are listed; and (b) Clearly state whether any of the medical devices presented in the same article are listed under the MDACS or not. 5.13.3 Where the representation that the distributor is a listed Distributor, or that the distributor is in compliance with the MDACS requirements on listed Distributors, is in writing, then the statements required by 5.13.2 (a) and 5.13.2 (b) above shall be in the same format (in terms of font size, colour, etc.) as the aforesaid representation. 5.13.4 All advertised claims of a listed medical device shall align with the indications and instructions for use as listed with the MDD. Information that has not been listed or which may potentially or indirectly extend the usage of a listed medical device must not be included in advertisements. This is to ensure information provided in the advertisement falls within the scope of the listed uses of the medical device.
6.1 Validity of approval 6.1.1 If an application for inclusion on the List of Distributors is approved, the applicant will be included on the List for three (3) years.
6.2 Renewal of listing 6.2.1 The listed distributor shall submit an application for renewal of the listing to the MDD 10 / 23 GN-09:2026(E) between 12 weeks and 1 year (inclusive) before the expiry of the three-year validity period. No renewal application will be accepted outside of this submission window. 6.2.2 Applicants shall submit a new application if the distributor listing has expired.
6.3 Fees 6.3.1 No fee will be charged by the Government for the application or in relation to the inclusion of a distributor on the List of Distributors.
6.4 Undertaking by Applicant 6.4.1 The applicant shall, on the terms set out in the “Undertaking by Applicant” in the Application Form, undertake inter alia to indemnify the Government of the Hong Kong Special Administrative Region against any loss or claim that flows from any of the following: (a) Any act or default of the applicant; (b) Any defective design of the medical devices of the applicant; (c) Any defect in such medical devices; and (d) Any information supplied by the applicant to the Government.
6.5 Delisting of Distributors 6.5.1 A distributor on the List of Distributors may be delisted or removed from the List if any of the following circumstances arises: (a) The listed distributor fails to comply with the MDACS requirements including, but not limited to, those stipulated in Clause 5 of this Document; (b) The listed distributor fails to address or adequately address a situation that gives rise or that might give rise to a hazard of its medical devices or to a public health or public safety concern; or (c) The listed distributor has been wound up, dissolved or has ceased to exist; (d) the MDD considers the delisting necessary for public health or safety considerations; or (e) The delisting is requested by the listed Distributor.
6.6.1. For each listed Distributor, the entries on the List may include:
6.6.1 For each listed Distributor, the entries on the List may include: (a) The name, telephone number and address of the distributor; and 11 / 23 GN-09:2026(E) (b) The Listed Distributor Number assigned to the Distributor. 6.6.2 The List of Distributors will be publicly accessible.
6.7 Appeal 6.7.1 The distributor may appeal against a decision of the Distributor Listing Approval Board to reject an application, or the conditions imposed to a conditionally approved application, or to remove a Listed Distributor from the List of Distributors within fourteen (14) working days of being notified of the decision. 6.7.2 To appeal, the distributor shall write to the Secretary to Medical Device Administration Appeal Committee, c/o Medical Device Division, stating its grounds for appeal. 6.7.3 The lodging of an appeal against a decision of MDD does not suspend the decision unless MDD decides otherwise. 6.7.4 An appeal lodged after the time limit specified above will not be considered. 6.7.5 The distributor will be notified of the outcome of the appeal application within four (4) weeks following the submission of the appeal application and all the required supporting information (if applicable). The decision of the Medical Device Administration Appeal Committee shall be final.
7. Compliance with the Prevention of Bribery Ordinance
7. Compliance with the Prevention of Bribery Ordinance 7.1 Applicants and their employees or agents must not offer an advantage as defined in the Prevention of Bribery Ordinance (Cap. 201) to any government officer in connection with their applications or while having dealings of any kind with government departments.
8. Points to Note 8.1 The inclusion of an individual, person, company or partnership on the List of Distributors is not an endorsement in support or any recommendation whatsoever of that individual, person, company or partnership as a distributor of medical devices by the Department of Health. Nor does the inclusion imply that the distribution of medical devices by that individual, person, company or partnership is in compliance with the applicable laws or has the necessary regulatory approvals. The responsibility for ensuring the legality of the distribution rests with the distributor. 12 / 23 GN-09:2026(E)
9.1. Enquiries concerning this booklet and the MDACS should be directed to:
9.1 Enquiries concerning this booklet and the MDACS should be directed to: Medical Device Division, Department of Health. Telephone number: 3107 8484 Facsimile number: 3157 1286 Email address: mdd@dh.gov.hk Website: https://www.mdd.gov.hk/
10. References 10.1 Department of Health. Guidance Notes for Definitions and Abbreviations for Medical Device Administrative Control System. Guidance Notes GN-00. 10.2 Department of Health. Overview of the Medical Device Administrative Control System. Guidance Notes GN-01. 10.3 Department of Health. Guidance Notes for Adverse Event Reporting by Local Responsible Persons. Guidance Notes GN-03. 10.4 Global Harmonization Task Force: Definitions of the Terms Manufacturer, Authorised Representative, Distributor and Importer. Final Document SG1-N055:2009. 13 / 23 GN-09:2026(E)
11. Appendix I – Guidance on requirements for listing of distributors
11. Appendix I – Guidance on requirements for listing of distributors This appendix provides additional information and examples in the form of guidance on Clause 5 of this document. The guidance listed in this appendix is only for referencing during the establishment and maintaining of the required procedures, the distributor should establish and maintain its own procedures taking account of the workflow, operations, nature of medical devices, reporting and follow up requirements, organisation structure and needs of its own organisation. Clause Requirement Guidance 5.1.1 Zones in the premises - A layout that showing all the operating zones is recommended. - Each zone should be clearly segregated and indicated ◼ Example: Goods Receiving Area is segregated by blue-color tape on the floor and clear wording “Goods Receiving Area” posted on the wall of this area; ◼ Example: Rejected Goods Area is physically isolated in plastic box that with red-color label and clear wording “Rejected Goods” adhered outside the plastic box. - Zones where handling of medical devices should be physically segregated from other zones such as general office, toilet, zones for storing non-medical products unless it is justified. 5.1.2 Actions for access control - Possible access control can include, but not limited to, ◼ Key-lock control by designated persons; ◼ Authorized list posted at the entrance of the storeroom; ◼ Electronic access control system; ◼ Logbook for guest visitor. - Storeroom should be restricted from any personnel who are not carrying their activities inside the storeroom such as general administrative personnel. 5.1.3 Sufficient storage There should be sufficient space for routine activities such 14 / 23 GN-09:2026(E) Clause Requirement Guidance capacity as putting-away, sorting, pick-packing, cleaning, etc. 5.1.4 Sanitation A sanitation program is recommended Examples: Daily Sweeping floor, cleaning-up trash bin Weekly Vacuum cleaning Monthly Wiping walls Annually Sweeping Ceiling All the time Eating, drinking, chewing or smoking, or the storage of food, drink, smoking materials or personal medication in the storeroom should be prohibited 5.1.4 Pest control A programme and pest control layout that showing all the pest control location is recommended. Examples: Electric fly-killing device, rodent trap, insect bait, etc. 5.1.4 Spillage handling programme Where distributor is handling medical devices in liquid form, such as IVD reagent and contact lens solutions, the distributor should establish a procedure for handling of spillage to prevent medical devices being contaminated. Examples: cleaning process and usage of spillage kit, etc. 5.1.5 Storage conditions Distributor can make reference from the standards listed in Clause 2.5 of Recognized Standards RS-01 (List of Recognised Standards for Medical Devices) or seek clarification from the manufacturer for the meanings of the symbols shown on the labels for determining the requirements of storage conditions. 5.1.6 Temperature and humidity monitoring - Monitoring of temperature or humidity are only required when there are temperature or humidity storage requirements on the handled medical devices. - The monitoring of temperature and humidity can be conducted manually or by automatic data logger. 15 / 23 GN-09:2026(E) Clause Requirement Guidance - The intervals for checking and recording the temperature or humidity should be determined in according to, but not limited to, ◼ The classification or risk of the medical devices; ◼ The availability of resources; ◼ The ranges of the temperature or humidity requirements; ◼ The stability of the storage environment; and ◼ The activities will be carried out such as secondary packaging. - The number and locations of the monitoring sensors should be depending to the size and layout of the storeroom. - The checked results can be retained in the format of hard copy or in electronic means. 5.1.7 Calibration - Examples of equipment include, but not limited to: ◼ Thermometer; ◼ Data logger; ◼ Hygrometer; ◼ Electronic balance. - The calibration methods should be appropriate to the use of the equipment, for example: ◼ The calibration of a 2°C ~ 8°C cold chain used data logger should include 2°C ~ 8°C. 5.2.1 Quality management system If the quality management system of the distributor has been certifying by certification body accredited for quality management system by a Global Accreditation Cooperation Incorporated (GACI) (previously International Accreditation Forum (IAF)) member signatory and the scope of the quality management system are covering all the documented procedures stipulated in Clause 5, the distributor can submit a valid certificate and the quality 16 / 23 GN-09:2026(E) Clause Requirement Guidance manual of the quality management system instead of submitting the required documented procedures. Examples of quality management system are ISO 13485 or ISO 9001. 5.2.1 Documented procedures The contents of each procedure should at least cover the following sections: Title Name and identification of the procedure Version history Summary of each update on the procedure Purpose Purpose of the procedure Scope Types of medical device and circumstances to which the procedure applies Definitions/ Definitions and abbreviations of terms Abbreviations/ used References Referencing documents of the procedure Roles and Roles of responsibilities of the Responsibilities personnel taking part in the procedure Procedures Detailed and step-by-step descriptions of the control processes Records List of records related to the procedure 5.2.2 Record retention Records can be retained in the format of hard copy or in electronic means provided that the integrity of the data in the records is maintained. 5.2.3 Regular review of procedures - All the operation procedures should be reviewed from time to time (e.g. annually) to ensure the effectiveness of the procedures. For example, adding of maintenance service may need to update the maintenance procedure. - The outcome of the review, that may lead to update or 17 / 23 GN-09:2026(E) Clause Requirement Guidance no change of the procedures, should be documented. 5.2.3 Corrective and preventive actions (CAPA) - Corrective actions are actions to be taken to eliminate the cause of a detected non-conformity or other undesirable situation and to prevent recurrence. - Preventive actions are actions to be taken to eliminate the cause of a potential non-conformity or other undesirable potential situation. 5.3.1 Supply records - Supply records should include appropriate information to ensure the traceability of medical devices. - Traceability of medical devices can be achieved using medical devices’ unique identifier such as model number with batch number, serial number, unique device identifier, etc. - Examples of supply records ◼ Purchasing order from customer ◼ Documents associated with incoming medical devices ◼ Incoming quality check reports/records ◼ Storage records ◼ Cycle count/ stock take records ◼ Secondary packaging records ◼ Picking and packing records ◼ Delivery notes ◼ Medical device return records ◼ Medical device recall records - Supply records should be retained for a period of time not less than the projected service life of the medical device as defined by the manufacturer, or at least seven years from the date of medical device distributions, whichever is longer. 5.4 Scope of handling, storage - The distributor should identify the scope, where they are responsible for handling of medical devices, among the 18 / 23 GN-09:2026(E) Clause Requirement Guidance and delivery of medical devices whole supply chain. - The scope should be based on the contractual requirement(s) that agreed between the distributor and other related traders in the medical device supply chain. - The distributor shall comply with all the requirements in this Guidance Note within the defined scope - Examples: Cases Starting point Completed point 1 Receiving area of Dispatching area of distributor distributor 2 Dispatching area of Receiving area of retail importer shop 3 Importing bay of Receiving area of clinic cargo terminal 4 Dispatching area of Receiving area of upstream distributor downstream distributor 5.4 Operation flow and corresponding records Example: Steps Locations Examples of records Inbounding Receiving - Shipping documents area such as packing list, delivery notes or invoice issued from the manufacturer - Product final inspection report / certificate - Certificate of Conformity (CoC) - Temperature record (cold chain product) Incoming - Incoming inspection inspection records / checklists 19 / 23 GN-09:2026(E) Clause Requirement Guidance Putting away / segregation Released / Quarantine / Rejected good area - Stock entry records Storage - Stock take records - Cycle count records - Investigation report (in case of significant stock discrepancy) Secondary packaging Secondary packaging area - Label printing records - Secondary packaging batch records Picking Released good area - Picking list Packaging Dispatching area - Packing list Transportation Outdoor - Delivery notes - Invoice - Temperature record (cold chain product) Receipt Clinic - Signed delivery note or delivery note with chop from clinic Return and recall Returned or recalled area - Good returned notice and form 5.4.1 (a) Environmental conditions Examples: - External weather such as raining or heat wave; - Internal facility such as toilet built inside the warehouse; - Cleanliness and hygiene of the warehouse. 5.4.1 (b) Special storage or transport conditions - It is recommended to review the storage requirements and symbols shown on labels of medical devices to determine the storage and transport conditions. - Examples: 20 / 23 GN-09:2026(E) Clause Requirement Guidance ◼ Temperature such as ambient temperature, < 30° C, 15°C ~ 25°C, 2°C ~ 8°C, -25°C ~ -15°C ◼ Relative humidity such as < 65% ◼ Atmospheric pressure 5.4.1 (c) Expired medical devices - The distributor should ensure that medical devices with the earliest expired date are sold and/or distributed first. - Unless specifically requested, the distributor is not recommended to sell and/or distribute short-expired medical devices (such as 1-month shelf-life). 5.4.1 (d) Proper handling of medical devices Examples: - Medical devices should be stored off the floor and suitably spaced to permit cleaning and inspection; - There should be regular checks to ensure the storage area is free of waste and contamination; - Light sensitive medical device should be placing away from light source. 5.4.1 (e) Returned and recalled medical devices - Each returned or recalled medical devices should be clearly labeled and segregated, appropriate access control to returned or recalled devices should be applied. 5.4.1 (f) Incoming inspection - When receiving a medical device. It is recommended to have a checklist where lists all the necessary items to be inspected, for example: ◼ Correctness of the information shown on the labels such as model name, model code, batch number / serial number (S/N), quantity, expired date, special listing information (if any), etc.; ◼ Integrity of the packaging; ◼ Documents associated with the medical device such as Certificate of Conformity (CoC) or Temperature record (cold chain product). 5.4.1 Outgoing - Before product delivery, it is recommended to verify the 21 / 23 GN-09:2026(E) Clause Requirement Guidance (f) inspection following items: ◼ Model name, model code, batch number / serial number (S/N), quantity, expired date, special listing information (if any), etc.; ◼ Integrity of the packaging; ◼ Required shipping condition and associated equipment (such as cold box and data logger for cold chain product). 5.4.1 (g) Stock reconciliation - The interval for conducting stock reconciliation should be depending on the following factors: ◼ Risks of medical devices; ◼ Variety of medical devices; ◼ Size of the storeroom; ◼ Number of personnel involved; ◼ Complexity of operations. - Example: Annually, quarterly, monthly, etc. 5.5.1 Management of product recalls and field safety notices General procedures for Management of product recalls and field safety notices: - Receiving of safety alerts and field safety notice (FSN); - Determining the nature of the safety alerts or FSN; ◼ Field safety corrective actions; ◼ Product recalls; ◼ Product modifications; - Determining the need for the following actions: ◼ Notification to MDD or other regulatory authorities; ◼ Notification to manufacturers, LRPs, importer, etc.; ◼ Notification to the users with regard to the modifications; ◼ Investigations and reporting to relevant parties including MDD; ◼ Product recalls; 22 / 23 GN-09:2026(E) Clause Requirement Guidance ◼ Returning of product to manufacturers; - All the received safety alerts, FSN and follow-up records should be kept. 5.7.1 Complaints - Complaints can occur by telephone, fax, email, letter or in person, etc. - All types of complaints should be recorded. - It is recommended to have a complaint master list or complaint logbook. - If complaints are not investigated or handled, justification should be recorded. - Any correction, corrective action or preventive actions resulting from the complaint should be recorded. 5.10 List of medical device distributed Refer to Appendix II for a sample of list of medical device distributed. 23 / 23 GN-09:2026(E)
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