GN-10 — Guidance Notes GN-10 - Guidance Notes for Changes of Listed Medical Devices
Link directly to a passage with its anchor — for example #sec-1 — to open it highlighted. This reference version is generated from the authority’s publication and does not replace it. Language: English.
Edition
Number
Date of Revision Summary of Revision Reference
Number
0 30 November 2023 • First issue of GN-10
(Guidance Notes on Changes
for Listed Medical Devices)
GN-10:2023(E)
1 22 December 2023 • “Guidance Notes on Changes
for Listed Medical Devices”
was renamed to “Guidance
Notes for Changes of Listed
Medical Devices”
GN-10:2023(E)
2 19 July 2024 • Clause 4.3(b) (Flowchart A),
4.3(h) (Flowchart G), 5.2.1,
6.1, 7.2.1, 7.4.1 and Appendix
I are revised
• Clause 5.1.3, 5.3 (Withdrawal
of the Listing), Section 8
(Appeal) and Appendix II
(Documents required for
Change Application) are
added
• Update document format
GN-10:2024(E)
3 26 Jun 2026 • Clause 4.3(b) (Flowchart A),
Clause 4.3(c) (Flowchart B),
Clause 4.3(d) (Flowchart C),
Clause 4.3(f) (Flowchart E),
Clause 4.3(h) (Flowchart G),
Clause 5.1.3, 5.4, 7.1.1,
7.2.1, 7.6.1, 8.1, 11.1 and
Appendix I are revised
• Clause 5.3 (Changes which
do not require reporting to the
MDD), 7.1.2, 7.1.3, 7.1.4, and
9 (Compliance with the
Prevention of Bribery
Ordinance) are added
• Clause 7.7 is deleted
GN-10:2026(E) (Ed. 3) — official PDF page 2; original table columns, symbols and diagram connections
1.1 Purpose 1.1.1 During the life-cycle of a medical device, changes may take place from time to time. To safeguard public health, the information in the Medical Device Administrative Control System (MDACS), including details of listed medical devices, should be up-to-date. The Local Responsible Person (LRP) has the responsibility to timely inform MDD of any change to the listed medical device. This document aims to assist the LRP in categorising, managing and reporting changes of listed medical devices. It is intended to guide the LRP to differentiate changes to a medical device listed under MDACS and report the changes to Medical Devices Division (MDD) accordingly.
1.2 Background 1.2.1 A listed medical device undergone changes shall remain in compliance with the Essential Principles of Safety and Performance of Medical Devices, and the management of changes under MDACS should allow timely availability of the changed medical device in the market.
1.3 Scope 1.3.1 This document applies to all medical devices listed under MDACS. It sets out points for consideration by LRP when a listed medical device is in the process of change. Owing to the various possible scenarios for changes made to a device, it is not the intention of this document to describe every permutation and type of change that can occur. The LRP may contact MDD, for further clarification regarding the specific changes to a listed medical device.
2. Definitions and Abbreviations 2.1 Major Change means a change that could be expected to affect the safety, quality or performance (SQP) of a medical device. 2.1.1 A Major Change typically may: (a) result in risks to the patient not previously identified (b) increase the probability of existing hazards occurring (c) alter the presentation of existing or new risks to the user (may involve labelling changes or new indications for use) 2.2 Minor Change means a change that does not fall in the definition of Major Change.
2.3. Please refer to Guidance Notes GN-00 (Guidance Notes for Definitions and
2.3 Please refer to Guidance Notes GN-00 (Guidance Notes for Definitions and Abbreviations for Medical Device Administrative Control System) for other 5 / 25 GN-10:2026(E) definitions and abbreviations of the terms that appear in this document.
3. General Principles 3.1 To ensure continued compliance of the requirements on SQP of the listed medical device, a manufacturer must assess the effect of the change on the patient, practitioner and user of the medical device, and the impact of the change on the specifications of the device, and decide whether the change could reasonably be expected to impact the SQP of the device. When considering several simultaneous changes, this document can be used to assess each change separately. If any of the changes is considered as a Major Change, the said simultaneous changes shall be collectively considered as a Major Change. 3.2 Major Changes to the listed medical devices shall be implemented upon approval of the respective Change Applications. 3.3 The listing of a medical device will become invalid immediately if the said medical device undergoes any changes without notifying MDD within the specified timeframe or obtaining prior approval from MDD, as appropriate. If any Major Change has been implemented without prior approval by MDD, the concerned medical device will no longer be regarded as listed under MDACS, and the LRP shall cease to supply the medical device in a way that purports that the device is still listed under MDACS (e.g. displaying the HKMD number on the outer package or making such claims in the promotional materials). 3.4 More examples of changes are provided in Appendix 1. 6 / 25 GN-10:2026(E)
4. Determination of Major or Minor Changes 4.1 The following section presents flowcharts that serve as tools to assess whether a change is considered to be a Major Change. 4.2 The main flowchart serves as a generalised discussion of the broad principles that can be used to determine if a change would affect the SQP of a medical device. It is by no means inclusive of all scenarios. 4.3 Flowcharts A to G provide specific questions and answers to assist in determining if a change is considered to be major or minor. Flowchart: Decision on categorisation of changes 4.3(a) Main Flowchart General Changes made to Medical Devices 4.3(b) Flowchart A Changes in Manufacturing Processes, Facility or Quality Management System (QMS) (including Quality Control, QC) 4.3(c) Flowchart B Changes in Design for Medical Devices 4.3(d) Flowchart C Changes to Sterilisation Facility and its Process or Quality Management System 4.3(e) Flowchart D Changes to Software for Medical Devices 4.3(f) Flowchart E Changes in Materials for General Medical Devices 4.3(g) Flowchart F Changes in Materials for In Vitro Diagnostic (IVD) Medical Devices 4.3(h) Flowchart G Changes to Labelling, Special Listing Information or LRP’s contact information 7 / 25 GN-10:2026(E) 4.3(a) General Changes made to Medical Devices - Main Flowchart Is there a change in manufacturing processes, facility or Quality Management System (including Quality Control, QC)? Is there a change in design for medical devices? Is there a change to Sterilisation Facility and its Process or Quality Management System? Is there a change to software for medical devices? Is there a change in materials for general medical devices? Is there a change in materials for In Vitro Diagnostic (IVD) medical devices? Is there a change to labelling, Special Listing Information or LRP’s contact information? Minor Change 4.3(b) Flowchart A 4.3(c) Flowchart B 4.3(d) Flowchart C 4.3(e) Flowchart D 4.3(f) Flowchart E 4.3(g) Flowchart F 4.3(h) Flowchart G No No No No No No No Yes Yes Yes Yes Yes Yes Yes 8 / 25 GN-10:2026(E) 4.3(b) Changes in Manufacturing Processes, Facility or Quality Management System (including QC) – Flowchart A 2 1 Such changes only include presentation / abbreviations on the address, postal code or country name. 2 Such errors may include but not limited to typo, editorial and graphical errors. Is there a change that only involves the update of QMS validity date? Editorial change 1 or Change due to errors 2 Does the change to the manufacturing process, facility or equipment by the manufacturer and/or critical supplier that affects the device’s safety, quality and performance? Major Change Minor Change Is there an addition, deletion, or shift/change to the manufacturing facilities with a change to manufacturing process? Is there a change to the manufacturing control procedures, such as change of test acceptance criteria, in-process inspections or final quality control that affect the device’s safety, quality and performance? Does the change to the manufacturing quality control procedures alter the design specification of the device? Minor Change. Change to be recorded in Quality Management System and/or technical documentation of the medical device 4.3(c) Flowchart B No No No No No Yes Yes Yes Yes Yes Yes Major Change Do not require reporting to MDD. The Change should be recorded in Quality Management System and/or technical documentation of the medical device. Is there a change to any detail on Quality Management System certificate? No Major Change Yes No 9 / 25 GN-10:2026(E) 4.3(c) Changes in Design for Medical Devices – Flowchart B Is there a change to the control mechanisms or operating principles? Is there a change to the design characteristics or specification resulting in a change of the intended use? Does the change require additional pre- clinical and/or clinical data to support the safety, quality and performance of the device? Do the results of a risk analysis undertaken during the design validation process raise new issues of safety, quality and performance of the device? Is there a change to the design, manufacturing or components that change its intended performance? Minor Change No No No No No Major Change Yes Major Change Yes Major Change Yes Major Change Yes Major Change Yes 10 / 25 GN-10:2026(E) 4.3(d) Changes to Sterilisation Facility and its Process or Quality Management System (QMS) – Flowchart C 3 1 Sterile barrier system means minimum package that prevents ingress of microorganisms and allow aseptic presentation of the product at the point of use. Is there a change that increases the bioburden alert or action levels or that introduces a more difficult to kill organism? Is there a device design or material change that introduces a more difficult sterilisation change? Is there a change in sterilisation method or related processes for a medical device? Has a new acceptance criterion, or monitoring method, been added over and above the existing process to provide equivalent or better assurance of sterility, reliability or similar safety aspects? Major Change Has the change in the sterilisation method or process been reviewed in a previous application for similar medical devices, and is the proposed medical device easier to sterilise than the listed medical device? Minor Change Has the change in the packaging been reviewed in a previous application for similar devices, is the proposed device easier to sterilise than the listed medical device? Is there a change in sterile barrier system 1 ? Is there an addition, deletion, or shift of sterilisation facilities (with no change to sterilisation process)? Is there an update of QMS certificate for sterilisation facilities that solely involves the following issues? •Change in scope of QMS certification which does not affect the medical device; or •Change in certification body No No No Yes Yes Yes Yes Yes No No Yes Major Change No No No Minor Change Yes No Major Change Yes Minor Change Yes 11 / 25 GN-10:2026(E) 4.3(e) Changes to Software for Medical Devices - Flowchart D Is there a change to software which impacts the control of the device that may alter diagnostic or therapeutic function? Is there a change to software initiated by manufacturer that modifies algorithm that affects the diagnostic or therapeutic function of the medical device? Is there a change to software with addition of new features or software applications that affects any diagnostic or therapeutic functions of the medical device? Is there a change to software that includes addition or removal of alarm function, such that a response to this change affects the treatment of patient? Is there a change to software that affects the safety and performance of the listed medical device such that treatment or diagnostic of the patient is altered? Is there a change to software which incorporates a change to the operation system platform? Major Change Yes Major Change Yes Major Change Major Change Major Change Major Change Yes Yes Yes Yes Minor Change No No No No No No 12 / 25 GN-10:2026(E) 4.3(f) Changes in Materials for General Medical Devices – Flowchart E Is there a change in radiation source (e.g. radioisotopes) or types of medicinal substances in an ancillary role? Is there a change in type, source, processing and/or supplier of biological materials (including cells, tissues or derivatives of animal, human, microbial or recombinant origin) without a change in the intended purpose of the biological material? Is there a change in material formulation (of non-biological origin) including changes to device coating or surface modification techniques that is intended to make direct/indirect contact with body tissues and fluids or is absorbed by the body? Is there a change in materials that are used for shielding in medical devices emitting ionising radiation? Is there a change to concentration or drug specification of medicinal substances in medical devices that incorporate medicinal substances in an ancillary role? Is there a change in material, which results in design and/or specifications change of a medical device? Minor Change Major Change Major Change Major Change Major Change Major Change 4.3(c) Flowchart B No No No No No No Yes Yes Yes Yes Yes Yes 13 / 25 GN-10:2026(E) 4.3(g) Changes in Materials for In Vitro Diagnostic (IVD) Medical Devices – Flowchart F Does the change necessitate the testing of additional clinical samples to determine the performance characteristics of the IVD medical device? Does the additional clinical testing completed confirm that the altered IVD medical device still conforms to the performance specification and no labelling changes are necessary? Is there change in critical material, which results in a change to the performance specification of the IVD medical device? Minor Change No No Major Change Yes Minor Change No Yes Yes 4.3(c) Flowchart B 14 / 25 GN-10:2026(E) 4.3(h) Changes to Labelling, Special Listing Information or LRP’s contact information– Flowchart G 4 5 1 It may also include intended use, intended purpose and intended user Is there a change to labelling of the device that involves addition, removal and/or revision of intended use/ indication for use 1 ? Is there a change to labelling of the device that involves addition, removal and/or revision of contraindications, warnings, precautions and/or adverse event? Is there a change to pre-clinical or clinical data to support the changes in improving safety, quality and performance? Is there a change in shelf-life? Is the manufacturer’s address on the labelling changing? Major Change Major Change Major Change Major Change Minor Change No No No No No Yes Yes Yes Yes Yes Changes in colour, position of text or graphics in Special Listing Information Minor Change Is there a change in the Special Listing Information? (refer to GN-01) Major Change Other changes in LRP’s contact information, such as contact person and post, e-mail, contact telephone for public enquiries, mobile telephone for urgent use (24 hours), address of LRP’s premises, etc. No Minor Change No Yes Yes For such change(s) of contact information that do not induce a change in Special Listing Information of the listed device, please update the information in MDIS No Yes 15 / 25 GN-10:2026(E)
GN-10:2026(E) (Ed. 3) — official PDF page 7; original table columns, symbols and diagram connectionsGN-10:2026(E) (Ed. 3) — official PDF page 8; original table columns, symbols and diagram connectionsGN-10:2026(E) (Ed. 3) — official PDF page 9; original table columns, symbols and diagram connectionsGN-10:2026(E) (Ed. 3) — official PDF page 10; original table columns, symbols and diagram connectionsGN-10:2026(E) (Ed. 3) — official PDF page 11; original table columns, symbols and diagram connectionsGN-10:2026(E) (Ed. 3) — official PDF page 12; original table columns, symbols and diagram connectionsGN-10:2026(E) (Ed. 3) — official PDF page 13; original table columns, symbols and diagram connectionsGN-10:2026(E) (Ed. 3) — official PDF page 14; original table columns, symbols and diagram connections
5.1 Major Changes 5.1.1 The LRP shall report any Major Change of a listed medical device by submitting a Change Application to MDD as soon as possible, and shall be at least 12 weeks prior to any planned implementation.
5.1.2. MDD may require the LRP to submit, when necessary, any information and
5.1.2 MDD may require the LRP to submit, when necessary, any information and documents as the basis for supporting the change. All certifications/ licences relating to the listed device shall remain valid and be made available to MDD upon request. 5.1.3 For transfer of LRP of a listed medical device, it is regarded as a Major Change and the party taking over (applicant) shall submit the Takeover Application in MDIS.
5.2 Minor Changes 5.2.1 While Minor Changes could be implemented before obtaining approval from MDD, the LRP shall notify MDD by submitting a Change Application within 24 weeks from the time the LRP is aware of the change.
5.3. Changes which do not require reporting to the MDD
5.3 Changes which do not require reporting to the MDD Changes limited to 5.3.1 to 5.3.18 below do not require reporting to the MDD. Nonetheless, such change(s) shall be recorded in the QMS of the manufacturer and/or technical documentation of the medical device, as the case may be. However, if any of the change(s) are result of safety alert/ adverse event, or may be conceived to impact safety, quality and performance of the listed medical device, such change(s) should be reported to MDD by Change Application in MDIS as either Major Change or Minor Change. 5.3.1 Replacement, addition or removal of raw material suppliers not engaged for production of the whole medical device but just a part of or constituting components of the medical device
5.3.2. Replacement, addition or removal of manufacturing sites not engaged for
5.3.2 Replacement, addition or removal of manufacturing sites not engaged for production of the whole medical device but just a part of or constituting components of the medical device 5.3.3 Replacement, addition or removal of sub-contractors not engaged for production of the whole medical device but just a part of or constituting components of the medical device 5.3.4 Replacement, addition or removal of sterilisation facility(ies) not engaged for production of the whole medical device but just a part of or constituting components of the medical device 5.3.5 Replacement, addition or removal of equipment used in manufacturing process 16 / 25 GN-10:2026(E) without change to manufacturing process 5.3.6 Update of validity of marketing approval certificates without change in the listed medical device 5.3.7 Update of validity of licences under local ordinance without change in the listed medical device 5.3.8 Addition in scope of QMS certificate of the manufacturer which does not affect the listed medical device 5.3.9 Change in validity of QMS certificate of the manufacturer which does not affect the listed medical device 5.3.10 Addition in scope of QMS certificate of the manufacturing site(s) which does not affect the listed medical device 5.3.11 Change in validity of QMS certificate of the manufacturing site(s) which does not affect the listed medical device 5.3.12 Change in manufacturer's contact person / telephone with respect to information recorded in application form in MDIS 5.3.13 Change in contact details of LRP recorded in MDIS, but do not induce a change in Special Listing Information of the listed medical device. For such change, LRP shall instead update the information in MDIS 5.3.14 Routine update of Clinical Evaluation Report without resulting in design / material / labelling change to the listed medical device 5.3.15 Routine update of Risk Management Report without resulting in design / material / labelling change to the listed medical device
5.3.16. Routine update of Essential Principles Conformity Checklist (Form MD-CCL)
5.3.16 Routine update of Essential Principles Conformity Checklist (Form MD-CCL) complied without resulting in design / material / labelling change to the listed medical device 5.3.17 Routine update of Essential Principles Conformity Checklist for In Vitro Diagnostic Medical Devices (Form MDIVD-CCL) complied without resulting in design / material / labelling change to the listed medical device 5.3.18 Routine update of version of standards complied without resulting in design / material / labelling change to the listed medical device
5.4 Withdrawal of the Listing (Delisting) 5.4.1 If LRP wishes to apply for withdrawal of the Listing (Delisting), please submit the Delisting Application tin MDIS. 17 / 25 GN-10:2026(E)
6.1. For the listed medical device having Major Change(s) where LRP intends to
6.1 For the listed medical device having Major Change(s) where LRP intends to concurrently supply the original version and changed version, LRP shall include in the Change Application a proposed schedule of such arrangement. Upon approval of the Change Application, the concerned medical device shall be supplied in the changed versions. The original version could only be supplied in the market concurrently, if they are still in compliance with the Essential Principles of Safety and Performance of Medical Devices as stipulated in MDACS. Unless otherwise specified by MDD, transition to the changed version shall be completed in 24 weeks, or any time upon MDD’s instruction. 6.2 The LRP shall ensure that appropriate mechanisms are in place for the consumers and users to differentiate and identify the changed device, in particular self-use medical devices, from the original version based on device or manufacturing attributes (e.g. batch / lot / serial number, expiry date), and maintain relevant supply records to ensure traceability of both versions. All supply records shall be made available to MDD upon request.
7.1 Change Application form 7.1.1 An application for change to the listed medical device shall be made by submission of Change Application form via MDIS. The other guidance notes related to MDACS can be obtained from MDD website at https://www.mdd.gov.hk. 7.1.2 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 acceptable 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 acceptable 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. 7.1.3 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 purported scanned copy of an original certificate or document). Such certification 18 / 25 GN-10:2026(E) 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. 7.1.4 All documents shall be submitted in either Simplified Chinese, Traditional Chinese or English. Documents in other languages shall be accompanied by a translation in English or Chinese. Where the original document is not in English or Chinese, both the original document and its certified translation shall be submitted upon application. Where applicable, the accuracy of the translation shall be demonstrated upon request through any of the following evidence: (a) The translated version(s) is covered by the supporting marketing approval(s); (b) The translation was conducted by a service provider certified with ISO 17100 or an equivalent standard; or (c) A declaration administered by a notary public is submitted, indicating that the concerned version is an accurate representation of the original document.
7.2 Submission of Change Applications 7.2.1 The Change Application shall be submitted to MDD through the online Medical Device Information System (MDIS) (https://mdis.mdd.gov.hk/).
7.3. Acknowledgement upon receipt of a Change Application
7.3 Acknowledgement upon receipt of a Change Application 7.3.1 Upon receiving a Change Application, MDD will acknowledge its receipt. In the event that the acknowledgement is not received within a period of 2 weeks after the submission of the Change Application, the LRP may contact MDD to enquire whether the submission has reached MDD.
7.4 Circumstances requiring new listing 7.4.1 It is the discretion of the MDD to require the LRP to submit a new application for the device based on the information submitted. For the change of manufacturer’s name, the LRP shall submit a new listing application instead of a Change Application. Please refer to MDD website at https://www.mdd.gov.hk for the latest version of guidance notes on listing of medical devices.
7.5. Multiple submissions for changes or subsequent changes
7.5 Multiple submissions for changes or subsequent changes 7.5.1 In general, multiple submissions of Change Applications of the same device will not be accepted by MDD when a previously submitted Change Application is still 19 / 25 GN-10:2026(E) under evaluation. 7.5.2 Should two Change Applications be unavoidable, the LRP shall withdraw the Change Application under evaluation and submit a new Change Application including all changes and supporting documents.
7.6 Application results 7.6.1 A Change Application to a listed medical device may either be rejected, approved, or approved conditionally. The LRP will be notified of the result by letter via MDIS. Where the application is approved conditionally, this letter will also specify the special conditions on which the approval is given. Failure of the manufacturer or the LRP to comply with those conditions can result in their names and the device being removed from The Lists of Medical Devices. 7.6.2 In case a Change Application is rejected, the LRP shall not proceed with the change, otherwise the listing status of the device will become invalid immediately.
8. Appeal 8.1 The LRP may appeal against a decision of the Medical Device Listing Approval Board to reject a Change Application, or the conditions imposed to a conditionally approved application, or to remove the listed medical device from the List of Medical Devices within fourteen (14) working days of receiving the notification of the decision. 8.2 To appeal, the LRP must write to the Secretary to Medical Device Administration Appeal Committee, c/o Medical Device Division, stating its grounds for appeal. 8.3 The lodging of the appeal against a decision of MDD to reject a Change Application does not suspend the decision unless the MDD decides otherwise. 8.4 An appeal lodged after the corresponding time limit specified above will not be considered. 8.5 The LRP 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.
9. Compliance with the Prevention of Bribery Ordinance
9. Compliance with the Prevention of Bribery Ordinance Applicants and their employees or agents must not offer an advantage as defined in the Prevention of Bribery Ordinance (Chapter 201) to any government officer in connection with their applications or while having dealings of any kind with government departments. 20 / 25 GN-10:2026(E)
10. Enquiries Enquiries concerning this document and 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: www.mdd.gov.hk
11. References 11.1 Global Harmonization Working Party. Change Management to Registered Medical Devices. GHWP/WG2-WG1-WG3/F001:2024. http://www.ahwp.info/index.php/. accessed on 2 June 2026. 11.2 International Organization for Standardization. Medical devices — Quality management systems — Requirements for regulatory purposes. ISO 13485. 11.3 Department of Health. Guidance Notes for Definitions and Abbreviations for Medical Device Administrative Control System. Guidance Notes GN-00. 11.4 Department of Health. Overview of the Medical Device Administrative Control System. Guidance Notes GN-01. 11.5 Department of Health. Guidance Notes for Listing Class II/III/IV General Medical Devices. Guidance Notes GN-02. 11.6 Department of Health. Guidance Notes for Listing Class B/C/D In Vitro Diagnostic Medical Devices. Guidance Notes GN-06. 11.7 Department of Health. Essential Principles of Safety and Performance of Medical Devices. Technical Reference TR-004. 21 / 25 GN-10:2026(E)
12. Appendix I Examples of Changes Category Change Type of change Changes in manufacturing process, facility or Quality Management System (QMS) Changes to QMS Certificate, such as: Change/Addition/Removal of manufacturing facility Major Change of device manufacturing process from casting to 3D printing Major Change of manufacturing route of the device Major A change in supplier that extrudes the polymer tubing with no change in finished product performance specifications Minor Change of address of manufacturer Major An editorial change in the manufacturer’s address shown on QMS certificate (e.g. from “518063 Shenzhen, China” to “Shenzhen, 518063, P.R. China”) Minor Change in validity date of QMS certificate of the manufacturer which does not affect the listed medical device Non- reportable Replacement of equipment used in manufacturing process without change to manufacturing process Non- reportable Changes to sterilisation facility and its process or QMS Change of sterilization method (e.g. from gamma irradiation to ethylene oxide) Major Change in moist heat sterilisation parameters Major Change to the packaging where a single pouched sterile device is put into a new double pouch Major Change of contract sterilizers (with no change to cycle parameters), the method of validating the process remains the same Minor Replacement of sterilisation facility from Company “A” to Company “B” that not engaged for production of the whole medical device, but just a part of the medical device Non- reportable Change in design for medical devices Change from a quantitative assay to a qualitative assay Major Change in the design characteristics that allows for additional or broader intended use Major Addition of a footswitch to an X-ray system Major 22 / 25 GN-10:2026(E) Category Change Type of change that previously do not operate with a footswitch mechanism A device is modified to use an internal battery instead of an external AC power source. Major The addition of a new component, a combined filter and disposable cartridge for convenience Major Addition of two new stent lengths which are outside of the range of previously listed stent lengths Major Addition of two new stent lengths which are within the range of the previously listed stent lengths Minor Reduction in size of the wire diameter to reduce the overall pacing lead diameter, facilitating smaller introduction into the vessel Major Modification of a detachable handle that allows the user to torque the lead body in order to provide a more ergonomic feel Major A change to the throughput or test volume of a clinical chemical analyser Major Changes to software Insulin Pump – Software changes that allow for wireless communication with compatible blood glucose monitors Major Upgrade of software version changes the performance characteristics like specificity or sensitivity of the In-vitro diagnostic medical device Major The addition of new features or software applications Major Addition to software of an early warning alarm of an electrocardiogram to signal a potential cardiac event such as atrial fibrillation Major Change in software of electrocardiogram that provides or adds a visual on-screen alarm to an existing audible alarm Minor Bug fixing to correct the display error on the data table from the software analysis result Minor Change in software to alter colours and location of menu on graphic user interface of Minor 23 / 25 GN-10:2026(E) Category Change Type of change medical devices that does not affect safety and performance of the device but results in version change Change in software to strengthen the cybersecurity Minor Change in materials for General Medical Devices Change in the drug of a drug eluting stent Major Change in the concentration of the drug in a drug eluting stent Major Change of material to a cardiovascular catheter that comes in contact with body tissue Major Introduction of a colourant change into the flush port is an access port for flush syringes for IV line clearance or volume block and is not intended to be used for fluid administration or withdrawal from a patient Minor Change of raw material suppliers not engaged for production of the whole medical device but just a part of the medical device Non- reportable Changes in materials for IVD Medical Devices Change of formulation of a reagent that increase the performance (e.g. sensitivity) Major Change of sources or types of materials (e.g. conjugate, antibodies, antigens) Major A change to the sample preparation, such as the inclusion of a stabilizer for an IVD medical device that is intended to simplify preparation requirements or increase sample stability Major Change in the preservatives or the formulations of existing materials that does not affect the performance characteristics or lead to labelling changes Minor Change of raw material suppliers not engaged for production of the whole medical device but just a part of the medical device Non- reportable Changes to Labelling and Special Listing Information Change of Instructions for Use (IFU) that involves a change from ‘professional use only’ to ‘home use’ Major All changes to the labelling/ IFU that involve addition, removal or revision of warnings, precautions, contraindications and potential adverse events Major 24 / 25 GN-10:2026(E) Category Change Type of change Addition /Revision / removal of approved indications / intended use on IFU Major Addition of Magnetic Resonance (MR) conditional section and the symbol in IFU and labelling Major Change of product shelf life (from 2 years to 3 years) Major Change of device’s storage conditions Major Addition of languages, other than Chinese or English required in other regulatory jurisdictions Minor Change to the label due to typo error Minor The Special Listing information of the device is now displayed on the outer package of each unit, where it was previously displayed on the delivery note (or vice versa) Major Change in telephone numbers or address of LRP applied in the Special Listing information Major Provision of Chinese IFU for the device and induce a change in Special Listing Information Major Change in LRP’s name (not transfer of LRP) and induce a change in Special Listing Information Major Other changes Change to Asian Medical Device Nomenclature System (AMDNS) code Minor Routine Update of Clinical Evaluation Report without resulting in design / material / labelling change to the listed medical device Non- reportable Routine Update of Risk Management Report without resulting in design / material / labelling change to the listed medical device Non- reportable Update of validity of marketing approval certificates without change in the listed medical device Non- reportable 25 / 25 GN-10:2026(E)
GN-10:2026(E) (Ed. 3) — official PDF page 21; original table columns, symbols and diagram connectionsGN-10:2026(E) (Ed. 3) — official PDF page 22; original table columns, symbols and diagram connectionsGN-10:2026(E) (Ed. 3) — official PDF page 23; original table columns, symbols and diagram connectionsGN-10:2026(E) (Ed. 3) — official PDF page 24; original table columns, symbols and diagram connections
13. Appendix II Documents required for Change Application
13. Appendix II Documents required for Change Application The below table serves as examples for documents required for certain changes in the Change Application. Nevertheless, MDD may require the LRP to submit any information and documents for supporting the change on a case-by-case basis. Documents required for submission in Change Application (For reference only) Examples of change QMS certificate LRP designation letter IFU, Labelling, Special Listing Information Risk Analysis, Clinical Evidence Test report or validation report Marketing approval(s) and Essential Principles documents Change of address of manufacturer ✓ ✓ If applicable If applicable ✓ Addition of manufacturing site ✓ If applicable If applicable If applicable If applicable Change in product design If applicable ✓ ✓ ✓ Addition of models outside the previously listed range ✓ ✓ ✓ ✓ ✓ Change in sterilisation method from gamma irradiation to ethylene oxide If applicable ✓ ✓ ✓ ✓ Change to software for new features ✓ ✓ ✓ ✓ Change in material If applicable ✓ ✓ ✓ Addition of approved indications / intended use on IFU ✓ ✓ If applicable ✓ Change in Special Listing Information (provision of Chinese IFU) ✓
GN-10:2026(E) (Ed. 3) — official PDF page 25; original table columns, symbols and diagram connections
