GN-02 — Guidance Notes GN-02 - Guidance Notes for Listing Class II/III/IV General Medical Devices
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Edition
Number
Date of
Revision
Summary of Revisions Reference
Number
0 2004 First issue of GN-02 (Guidance Notes for Listing
Class IV Medical Devices)
GN-02:2004(E)
1 7 July 2011 Issue of revised GN-02 (Jul 2011 Edition)
(Guidance Notes for Listing Class II/III/IV Medical
Devices)
The revised GN-02 supersedes the existing GN-02
(Guidance Notes for Listing Class IV Medical
Devices) and GN-05 (Guidance Notes for Listing
Class II/III Medical Devices).
Application Form for Listing of Class II/III/IV
Medical Devices is revised to MD-C2&3&4 (Jul
2011 Edition)
Reference is made to GN-00 for definitions and to
TR-003 for classification of medical devices
Appendix 3 Sample Essential Principles
Declaration of Conformity is added
GN-02:2011(E)
2 19 April 2021 Update document format;
Rename of Medical Device Control Office to
Medical Device Division;
Clause 5.3 (Submission of applications) has been
updated;
Clause 6 (Guide to Application Form MD-C2&3&4)
has been updated;
Appendix 1 Sample Application Form for Listing of
Class II/III/IV Medical Devices has been updated
to MD-C2&3&4 (2021 Edition); and
Appendix 2 Sample Essential Principles
Conformity Checklist has been updated to MD-
CCL (2021 Edition)
GN-02:2021(E)
2.1 30 August 2021 Appendix 1 Sample Application Form for Listing of
Class II/III/IV Medical Devices has been updated
to MD-C2&3&4 (2021 2nd Edition)
Modified the scope of accepted Marketing
Approvals
GN-02:2021(E)
3 1 January 2022 Appendix 1 Sample Application Form for Listing of
Class II/III/IV Medical Devices has been updated
to MD-C2&3&4 (2022 Edition);
GN-02:2022(E)
Edition
Number
Date of
Revision
Summary of Revisions Reference
Number
Note A003 and D001 in Clause 6 (Guide to
Application Form MD-C2&3&4) has been updated;
Updated document format.
4 1 January 2024 Appendix 1 Sample Application Form has been
removed
Appendix 2 Sample Essential Principles
Conformity Checklist has been removed
Appendix 3 has been renamed to Appendix I
Modified the scope of accepted Marketing
Approvals
GN-02:2024(E)
5 2 April 2024 “Make” is replaced with “Manufacturer”
Modified the scope of accepted Marketing
Approvals
Clause 5.5 (Time for vetting and approving an
application) is added
Application Form “MD-C2&3&4” is renamed as
“MD101”
Typo in Appendix I is corrected
Updated document format
GN-02:2024-1(E)
6 14 June 2024
Clause 5.1, 5.2, 5.3 and 6.1 are revised
Clause 5.4 and 5.5 are deleted
Updated document format
GN-02:2024-2(E)
7 8 August 2024 Addition of clause 5.4 (Notification of approval or
rejection of application)
Clause 6 is revised (Appeal)
Updated document format
GN-02:2024-3(E)
8 13 October
2025
Clause 7.1 is revised (Translation) GN-02:2025(E)
9 12 June 2026 Updated document format
Reference is made to TR-007, TR-008, and COP-
01
Appendix I is deleted
Clause 7 is added (Compliance with the
Prevention of Bribery Ordinance)
Clause 9 is added (Medical Devices Procured by
the Hospital Authority)
Clause 1.1, 3.2.1, 4.1, 5, 8, 11 are revised.
GN-02:2026(E)
10 31 July 2026 Clause 6.4, 8.3 and 8.4 are revised
Updated document format
GN-02:2026(E)
(Ed.1.0)
GN-02:2026(E) (Ed. 1.0) — official PDF page 2; original table columns, symbols and diagram connectionsGN-02:2026(E) (Ed. 1.0) — official PDF page 3; original table columns, symbols and diagram connections
1. Introduction 1.1 This document is to provide guidance to applicants applying for inclusion of Class II/III/IV general medical devices into the List of Medical Devices under the Medical Device Administrative Control System (MDACS). It provides detailed information to the applicants for preparing the application submission. Applicants should read this document in conjunction with the “Overview of the Medical Device Administrative Control System” (Guidance Notes GN-01), “Definitions and Abbreviations for the Medical Device Administrative Control System” (Guidance Notes GN-00), “Classification of Medical Devices” (Technical Reference TR-003), “Essential Principles of Safety and Performance of Medical Devices” (Technical Reference TR- 004), “Additional Medical Device Labelling Requirements” (Technical Reference TR- 005), “Code of Practice for Local Responsible Persons” (Code of Practice COP-01), and documents issued by the Medical Device Division (MDD) to have a thorough understanding of the MDACS before making the submission. Applicants applying for listing medical devices other than Class II/III/IV general medical devices shall make reference to the corresponding Guidance Notes accordingly.
2. Definitions and abbreviations 2.1 Please refer to “Definitions and Abbreviations for the Medical Device Administrative Control System” (Guidance Notes GN-00) for the definitions and abbreviations of the terms that appear in this document.
3.1 Classification of general medical devices 3.1.1 Based on the classification rules of the MDACS (which are in line with those promulgated by the International Medical Device Regulators Forum (IMDRF) (previously Global Harmonization Task Force (GHTF))), general medical devices are classified into four categories (Classes I to IV) according to their risk levels, Class IV being the category of the highest risk and Class I the lowest. The classification rules for defining the class of a general medical device are given in “Classification of General Medical Devices” (Technical Reference TR-003). 2 / 20 GN-02:2026 (E)(Ed. 1.0) 3.2 Determining Class II/III/IV general medical devices by the classification rules 3.2.1 Applicants should take into consideration all the classification rules given in “Classification of General Medical Devices” (Technical Reference TR-003) in order to establish the proper classification for the device. If more than one rule is applicable to the device, the rules resulting in the highest classification of the device shall apply.
4. Persons Eligible to Apply for the Inclusion of a Class II/III/IV General
4. Persons Eligible to Apply for the Inclusion of a Class II/III/IV General Medical Device into The List of Medical Devices 4.1 Only the Local Responsible Person (LRP) of the device can make the application. Please see Guidance Notes GN-01, Guidance Notes GN-03, and Code of Practice COP-01 for the requirements and obligations of an LRP.
5.1 Submission of applications 5.1.1 An application for inclusion of a Class II/III/IV general medical device into The List of Medical Devices shall be made on the Form MD101 through the online Medical Device Information System (MDIS) (https://mdis.mdd.gov.hk).
5.2 Acknowledgement of application 5.2.1 On receiving an application, the MDD will acknowledge the receipt of application via sending a notification to the applicant’s registered email. If an applicant does not receive the acknowledgement within two (2) weeks after submitting an application, the applicant may contact the MDD to check if the submission has been received by the MDD.
5.3. Time for vetting and processing an application
5.3 Time for vetting and processing an application 5.3.1 The vetting and approval of an application for listing a device should normally be completed within 12 weeks. This period commences upon the submission of the application and all required supporting information, including any supporting information requested during the assessment process. Failure to provide the requested supporting information within the stipulated timeframe will result in the closure of the application. 3 / 20 GN-02:2026 (E)(Ed. 1.0)
5.4. Notification of approval or rejection of application
5.4 Notification of approval or rejection of application 5.4.1 An application for inclusion of a device into The List of Medical Devices may either be approved, approved conditionally, or rejected. Notification of the result will be issued to the applicant. Following approval or conditional approval, a listing number will be assigned to the device. In cases of conditional approval, the applicant will be notified of the specific listing conditions, such as the annual submission of post- market surveillance reports. Non-compliance with any stipulated condition may result in the delisting of the device from the MDACS.
6. Appeal 6.1 The LRP may appeal against a decision of the Medical Device Listing Approval Board to reject an application, or the conditions imposed to a conditionally approved application, or to remove a Listed medical device from the List of Medical Devices within fourteen (14) working days of being notified of the decision. 6.2 To appeal, the LRP shall write to the Secretary to Medical Device Administration Appeal Committee, c/o Medical Device Division, stating its grounds of appeal. 6.3 The lodging of an appeal against a decision of MDD does not suspend the decision unless MDD decides otherwise. 6.4 An appeal lodged after the time limit specified above will not be considered. 6.5 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.
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. 4 / 20 GN-02:2026 (E)(Ed. 1.0)
8. Guide to Application Form MD101 8.1 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. 8.2 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 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. 8.3 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 neither in English nor Chinese, both the original document and its translation shall be submitted upon application. The contents of all submitted versions and translations of a document shall be consistent with each other. 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. 5 / 20 GN-02:2026 (E)(Ed. 1.0) 8.4 The following table explains how to complete the application form MD101 for Class II/III/IV general medical devices. Table 1 – Guide for completing the application form MD101 Item Explanation A001 Only the Local Responsible Person (LRP) of the device can make the application. This LRP shall be a legal person incorporated in Hong Kong OR a natural or legal person with a registered place of business in Hong Kong, such as a registered company or a solicitor firm. A manufacturer with a registered place of business in Hong Kong may elect to act as the LRP itself or designate another eligible body. A manufacturer without a registered place of business in Hong Kong shall designate an external body meeting the LRP requirements to make the application. Requirements of LRP are specified in item B001 to B003. Please select “Yes” if the manufacturer has designated an external LRP. Select “No, manufacturer itself acts as the LRP” if the manufacturer itself will act as the LRP. A002 Comprehensive details of the manufacturer shall be stated, including the name and address (in English or Chinese, or both), country/region, contact person, telephone number, and email address. The provision of a fax number and website is optional. The manufacturer’s name and address shall be the same as those stipulated in the following documents submitted by the applicant: (i) MDACS Conformity Assessment Certificate submitted in D001 and/or reference marketing approval certificate(s) submitted in D002; (ii) Letter for Designating a Local Responsible Person submitted in B002; and (iii) The device labelling submitted in Part C. A003 A Quality Management System (QMS) shall be established under the manufacturer’s registered name and address, covering all applicable processes. Compliance is indicated by selecting the applicable checkbox(es). For each selected QMS, a valid QMS certificate shall be submitted, the specific certificate number and corresponding expiry date shall be entered. Compliance shall be demonstrated by the following certificate(s): (i) ISO 13485 (or its identical national or regional adoption) certificate issued by a certification body accredited by a Global Accreditation Cooperation Incorporated (GACI) (previously International Accreditation Forum (IAF)) member signatory; (ii) GB/T 42061 certificate issued by China National Accreditation Service (CNAS) recognised certification body; (iii) Medical Device Manufacturing Licence issued by the National Medical Products Administration (NMPA); (iv) Medical Device Single Audit Program (MDSAP) certificate issued by MDSAP 6 / 20 GN-02:2026 (E)(Ed. 1.0) Item Explanation recognised Auditing Organization; or (v) Korean Good Manufacturing Practices (KGMP) certificate issued by Ministry of Food and Drug Safety (MFDS) recognised certification body. Where a GB/T 42061 certificate or Medical Device Manufacturing Licence is submitted, a valid marketing approval certificate issued by NMPA shall be submitted in D002. Where an MDSAP certificate is submitted, a valid marketing approval certificate(s) issued by at least one of the marketing approval jurisdictions specified in D002 that recognises MDSAP as satisfying its local QMS requirements shall be submitted in D002. Where a KGMP certificate is submitted, a valid Medical Device Product Licence issued by Korea Ministry of Food and Drug Safety (MFDS) shall be submitted in D002. B001 The LRP’s registered name, address, and Business Registration Certificate details are synchronised by default with the information maintained in the applicant’s account profile. The applicant shall bear full responsibility for keeping all particulars in the account profile up-to-date. Should any particulars require updating, modifications shall be made in applicant’s account profile directly. All particulars shall remain current and accurate at the time of submission and throughout the entire application process. The following contact information shall be stated to facilitate public communication and Department of Health’s urgent contact: (i) Contact Telephone for Public Enquiries: A telephone number dedicated to handling enquiries from the general public. (ii) Mobile Telephone for Urgent Use (24 hours): A designated telephone number maintained with continuous, uninterrupted operational availability for urgent and emergency use. (iii) Company Contact: Direct contact details for the officer(s) specifically responsible for the device in this application. All telephone, mobile, and fax numbers stated shall be valid Hong Kong local numbers. B002 Where an LRP is designated by a manufacturer to submit the application, an LRP designation letter shall be submitted. This letter shall be prepared in accordance with the requirements set out in Guidance Notes GN-01. Additionally, the effective date of designation shall be entered in the designated field. B003 Documented procedures covering the following activities shall be established and maintained by the applicant. The procedures shall be submitted in the designated fields. (i) Keeping of supply records; (ii) Complaint handling; (iii) Management of product recalls and Field Safety Notices; (iv) Handling of reportable adverse events in Hong Kong; (v) Tracking of specific medical devices (if applicable) (Refer to Guidance Notes GN-01 for the list of specific medical devices requiring tracking); and 7 / 20 GN-02:2026 (E)(Ed. 1.0) Item Explanation (vi) Maintenance and service arrangements (if applicable). Applicant without Valid LRP Listing Number For applicant without valid LRP listing number under the MDACS, an LRP application will be initiated concurrently and automatically in the MDIS. The completion and approval of the LRP application are essential prerequisites for the processing of the medical device listing application. Should the associated LRP application be closed or withdrawn for any reason, the medical device listing application(s) shall be closed accordingly. Applicant with Valid LRP Listing Number For applicant with valid LRP listing number under the MDACS, the LRP listing number may be quoted in lieu of re-submitting the aforementioned procedures. This exemption is applicable only under the following conditions: (i) The documented procedures corresponding to items (i) to (vi) have been previously submitted to and accepted by the MDD; and (ii) No subsequent changes, version updates, or amendments have been made to last accepted version. Applicant shall indicate whether any changes have been made to the last accepted version of the documented procedures. Compliance with Relevant Requirements Full compliance with all relevant requirements in documents issued by the MDD shall be ensured, including but not limited to Guidance Notes GN-01, Guidance Notes GN- 03, Code of Practice COP-01 as amended from time to time and as explained as in various Technical References. C001 The current or prior listing or application status of the device specified in Part C should be disclosed. This information is requested where the device has been previously listed or an application has been submitted to the best of the applicant’s knowledge. The applicable checkbox(es) should be selected. Where any of the conditions apply, the corresponding HKMD Listing Number or Listing Application Number should be stated in the designated field. C002 The brand name, model(s), and product code(s) shall be entered in English, Chinese, or both, as applicable. A separate entry line is required for each model. Multiple product codes associated with the same model should be consolidated into a single “Product Code” field. In such instances, each product code shall be separated by a comma within the same field. The model(s), and product code(s) shall be explicitly specified in the MDACS Conformity Assessment Certificate submitted in D001 or the reference marketing approval certificate(s) submitted in D002. Only medical Devices within listing scope of MDACS shall be stated in C002. Subject to listing approval, only information stated in C002 will be included in the List of Medical Devices under the MDACS and be displayed on the Listing Certificate. 8 / 20 GN-02:2026 (E)(Ed. 1.0) Item Explanation C003 The applicable checkbox should be selected to indicate whether it is an application for a single medical device, a medical device family, a medical device series or a medical device system. A medical device family is a group of medical devices having the same manufacturer, device description and classification, intended use, design, construction and performance e.g. catheters of different diameters and lengths. For each member of the medical device family, please state its identifier(s) (e.g. product number), a brief account of its characteristics that distinguish it from other members (e.g. dimensions of its various parts). A medical device series is a group of medical devices belonging to the same model series of a manufacturer and having the same device classification, intended use, but differing only in minor features or functions that do not present significantly different safety, performance and effectiveness issues. In principle, the designs, labelling, manufacturing processes and performance specifications cannot be significantly different between members of a series. For each member of a medical device series, please state its identifier(s) (e.g. model number), and a brief account of its minor features that distinguish it from other members. A medical device system is a medical device comprising a number of medical devices (component medical devices) intended to be used together to fulfil the system’s intended use. All component medical devices shall be placed on the market under the name of the same manufacturer. A short description on how the component medical devices are used together to achieve the intended purpose of the medical device system shall be stated. For each component medical device of a medical device system, please state its Asian Medical Device Nomenclature System (AMDNS) term (if an AMDNS term is not available for a particular component, a short description shall be stated) and the corresponding AMDNS code, its identifier(s) (e.g. model number), and a brief description of its intended use. Additional information concerning the medical device family, medical device series or medical device system should be stated on separate sheets in formats similar to sample MDS-01 in Clause 12. Irrespective of nature of product, information shown in MDS-01 is not considered as part of the listing and will not be displayed on the Listing Certificate. C004 The Asian Medical Device Nomenclature System (AMDNS) code and term shall be stated with reference to the AMDNS database on the MDD website. In the absence of an applicable AMDNS term, a short description of the device shall be stated. Other nomenclature codes, such as the Global Medical Device Nomenclature (GMDN) code, NMPA Classification Code, should be entered to facilitate device classification and identification. C005 Any synonymous terms, clinical descriptors, or alternative trade names not captured in C004 should be stated. 9 / 20 GN-02:2026 (E)(Ed. 1.0) Item Explanation C006 Intended use of the device shall be stated in English, Chinese, or both. This statement shall be in agreement with the information stated in the device labelling. The intended use shall be supported by the MDACS Conformity Assessment Certificate submitted in D001 and/or the reference marketing approval certificate(s) submitted in D002. The intended use shall be substantiated by the Clinical Evaluation Report, Risk Analysis Report, and other supporting technical documentation to demonstrate conformity with Essential Principles of Safety and Performance of Medical Devices (Technical Reference TR-004). C007 Where applicable, all accessories for the device shall be specified. An accessory is regarded as an article intended specifically by its manufacturer to be used with the device to enable that device to be used in accordance with its intended purpose. For a medical device series or medical device system, the specific member or component medical device with which each accessory is intended to work to achieve the intended use should be indicated. The details of all accessories, including their identifier(s) (e.g., part number) and descriptions should be submitted in separate sheets in a format similar to sample MDS- 02 in Clause 13. Irrespective of nature of product, information shown in MDS-02 is not considered as part of the listing and will not be displayed on the Listing Certificate. C008 The applicable classification rule and device classification shall be stated in accordance with Technical Reference TR-003. If more than one classification rule is applicable, the primary classification rule that assigns the device to the highest risk class shall be entered in Rule 1. The specific reasons for classifying the device as a Class II, III, or IV device should be stated in the designated field. The relevant characteristics of the device shall be indicated where applicable. All indicated characteristics shall be consistent with the technical specifications and labelling submitted in the application. It shall be noted that only devices classified as Class II, III, or IV falling within the current listing scope of the MDACS shall be included in this application. In cases involving multiple models with distinguishing characteristics, the application may be split into separate submissions accordingly. C009 The applicable checkbox(es) shall be selected to indicate any special characteristics of the device, including "SaMD" (Software as a Medical Device), "SiMD (Software in a Medical Device)", and "AI-MD" (Artificial Intelligence Medical Device). For the definitions of “SaMD”, “SiMD”, and “AI-MD”, reference shall be made to Technical References TR-007 and TR-008. 10 / 20 GN-02:2026 (E)(Ed. 1.0) Item Explanation C010 All manufacturing sites for the medical device within the scope of the application shall be specified. In the case of a medical device system, all manufacturing sites for the system itself, as well as those for its component medical devices, shall be stated. Manufacturing site(s) of the same manufacturer not involved in the production of the device intended for the Hong Kong market need not be included. Furthermore, manufacturing sites or subcontractors not engaged for production of the whole medical device but just a part of or some constituting components of the medical device need not be included. Quality Management System (QMS) certificates covering all specified manufacturing sites shall be submitted. For each manufacturing site, the certificate number and expiry date of the corresponding QMS certificate shall be entered. The name and address of each manufacturing site shall be the same as those stipulated in the corresponding QMS certificates. Where applicable, these details shall also align with the information in MDACS Conformity Assessment Certificate submitted in D001, reference marketing approval certificate(s) submitted in D002 and/or the device labelling. Reference shall be made to item A003 for the list of recognised QMS certificates. C011 Any history of previous recalls, reportable adverse events, banning in other countries, or proactive post-market surveillance studies shall be disclosed. The applicable checkbox(es) shall be selected to indicate the nature of the event(s). Where to the best knowledge of the applicant, safety alert case number(s) (in the format of HK-XXXX-XXXX or NL-XXXX-XXXX) and/or adverse event case number(s) (in the format of AE-XXXX-XXXX) has been created in MDACS, the corresponding case number should be stated. Where any recalls have been initiated, the details, causes, corrective and preventive actions (CAPA) taken, and the status of the recalls shall be submitted. Where any adverse events involving the same device, or a design substantially similar to the device, have been reported to an overseas regulatory authority, the following information shall be submitted: (i) Dates of the events; (ii) Names of the regulatory authorities to which the events were reported, and the dates of the reports; (iii) Causes of the events; (iv) Number of deaths and the serious injuries in these events; and (v) Corrective and preventive actions taken (including actions taken to prevent recurrence of similar events) and the implementation status. Where the device has been banned or restricted by any overseas regulatory authority, the dates, causes and related regulatory authorities shall be submitted. Where any post-market surveillance studies have been conducted, details and results 11 / 20 GN-02:2026 (E)(Ed. 1.0) Item Explanation of those studies shall be submitted. C012 The applicable checkboxes shall be selected to indicate the intended user groups and device usage. For the definition of 'lay person', reference shall be made to Guidance Notes GN-00. This selection shall be consistent with the device labelling, Clinical Evaluation Report, Risk Analysis Report, and other supporting technical documentation. Where the disposal of used device or any part thereof (including any used accessories or consumables) requires special precautions, the applicable checkbox should be selected and a description of the precaution should be stated. C013 The available language(s) of the Instructions for Use (IFU) shall be selected from English, Chinese, or both. For devices intended for use by a lay person, the IFU shall be submitted in both English and Chinese. In instances where no IFU is submitted, rationale for the non-provision shall be entered. The rationale shall be substantiated by the technical documentations submitted (e.g. Clinical Evaluation Report and Risk Analysis Report, declaration letter from manufacturer, etc.) to demonstrate that the device can be used safely and as intended without such instructions. All labelling, including instructions for use, manuals, device and package labels (as specified in Technical Reference TR-005) and a sample of Special Listing Information (as specified in Guidance Notes GN-01), shall be submitted. Where the labelling is displayed on the packaging and there is no separate instruction manual, clear colour images of the packaging in PDF or JPEG format showing all the labelling information shall be submitted. The LRP may be required to submit a sample of the device for inspection or testing if considered necessary and practicable. If electronic labelling is included, the corresponding website address shall be stated. Notwithstanding the availability of electronic labels or online links, a copy of the labelling in PDF format shall be submitted to the MDIS platform as part of the formal submission. Device brochures illustrating the usage and applications of the device should be submitted as far as possible. The document title and the page or section number where the following information is specified should be stated in the designated field: (i) indications for use; (ii) contraindications; (iii) cleansing, disinfection and/or sterilization procedures; (iv) user precautions; and (v) disposal precautions. C014 The applicable checkbox(es) shall be selected to indicate if the device is subject to specific statutory requirements, including the Radiation Ordinance (Cap. 303), the Pharmacy and Poisons Ordinance (Cap. 138), the Antibiotics Ordinance (Cap. 137), 12 / 20 GN-02:2026 (E)(Ed. 1.0) Item Explanation the Dangerous Drugs Ordinance (Cap. 134), and the Telecommunications Ordinance (Cap. 106). Where applicable, the required licence(s) or permit(s) of the corresponding ordinance(s) (e.g., Irradiating Apparatus Licence, Wholesale Dealer Licence) shall be submitted. It shall be noted that the ordinances listed are not considered exhaustive. Full compliance with all other relevant legislation in the Hong Kong Special Administrative Region remains the responsibility of the applicant. C015 Risk Analysis: A risk analysis shall be conducted in accordance with ISO 14971 or equivalent standards. A risk analysis report or a compressive summary, documenting the risks identified during the risk analysis process and the mitigation measures implemented to control the risk to an acceptable level, shall be submitted in the designated field. Supporting information (e.g. benefit-risk analysis, Failure Mode and Effects Analysis (FMEA), etc.) shall be submitted upon request. List of Standards: A comprehensive list of all international or national safety, performance and quality standards to which the device conforms shall be stated in the designated field. The year or version of each applicable standard shall be stated. Non-clinical Studies: Technical documentation of the device shall be submitted upon request to demonstrate conformity with applicable international or national standards, recognised industry best practices, and Essential Principles of Safety and Performance of Medical Devices (Technical Reference TR-004). The following documentation should be submitted where applicable: (i) Test Report or Test Certificate: Relevant test reports and compliance certificates from type testing performed by the manufacturer or an accredited third-party body. (ii) Biological, Sterile, or Medicinal Substance Documentation: Chemical/material characterization, biocompatibility and toxicology evaluation, non-material-mediated pyrogenicity, safety of materials of biological origin, sterilization validation for devices incorporating biological materials, medicinal substances, or components intended to contact body tissues or fluids. (iii) Electrical Systems: Technical data supporting the safety, mechanical, and environmental protection and electromagnetic compatibility for devices whose operation depends on a source of electrical energy. (iv) Radiation Safety: Technical data supporting radiation safety for devices emitting ionizing and/or non-ionizing radiation or where the device is exposed to radiation. (v) Mandatory Technical Reference Documentation: Specific technical documentation shall be submitted in accordance with relevant Technical References issued by the MDD. This includes, but is not limited to, software verification and validation, software versioning and its traceability, 13 / 20 GN-02:2026 (E)(Ed. 1.0) Item Explanation cybersecurity management documentation required in Technical Reference TR-007, and Artificial Intelligence (AI) documentation required in Technical Reference TR-008. (vi) Others: Additional documentation may be requested by the MDD where necessary to verify compliance with safety, quality and performance requirements. C016 Clinical evaluation is a set of ongoing activities that use scientifically sound methods for the assessment and analysis of clinical data to verify the safety, clinical performance and/or effectiveness of the device when used as intended by the manufacturer. In general, clinical evaluation should be conducted through the following processes: (i) identify the Essential Principles that require support from relevant clinical data; (ii) identify available clinical data relevant to the medical device and its intended use; (iii) evaluate (appraise and analyze) clinical data in terms of its suitability and contribution to demonstrating the safety, clinical performance and/or effectiveness of the medical device in relation to its intended use; (iv) generate clinical data needed to address remaining questions of safety, clinical performance and/or effectiveness; and (v) bring all the clinical data together to reach conclusions about the safety, clinical performance and/or effectiveness of the medical device. The results of this process shall be documented in a clinical evaluation report. The report should include a summary and evaluation of the clinical evidence provided to demonstrate conformity with the Essential Principles specified in “Essential Principles of Safety and Performance of Medical Devices” (Technical Reference TR-004). This includes any clinical studies (pre- and/or post-market) conducted by the manufacturer and/or results of a literature review. In the case of a literature review, the report should include an evaluation of the relevance of the papers reviewed and the extent to which the devices referenced are comparable to the devices in application. Furthermore, the clinical evaluation plan shall be submitted upon request to substantiate the suitability of evaluation methodology for the device in application. C017 Clear colour images in PDF or JPEG format of the device and its accessories shall be submitted. The images should show the front, side, and back views of the device and its accessories where applicable. For devices in digital form, such as Software as a Medical Device (SaMD), representative screen captures that specify the software version shall be submitted. All images shall accurately reflect the device covered in the application. D001 The applicable checkbox(es) shall be selected to indicate the availability of MDACS Conformity Assessment Certificate and/or reference marketing approval(s) for the device. 14 / 20 GN-02:2026 (E)(Ed. 1.0) Item Explanation Where MDACS Conformity Assessment Certificate issued by one of the Conformity Assessment Bodies recognised by MDD is available, the Certificate shall be submitted in the designated field. The corresponding MDACS Conformity Assessment Body number, QMS Certificate number, and Certificate expiry date shall be stated. D002 Where MDACS Conformity Assessment Certificate is not available, marketing approval documents from the jurisdictions stated in D002 shall be submitted. Availability of marketing approval documents is indicated by selecting the applicable checkbox(es). The corresponding approval documents shall be submitted in the designated field. Certificate number, issue date, expiry date of the submitted document shall be entered where applicable. To facilitate the assessment of the application, all relevant certificates and approval documents should be submitted as far as possible. Valid Certificate of Free Sale shall be submitted upon request. All product model(s) and product code(s) shall be explicitly specified in the marketing approval certificate(s) and supporting documents submitted. The following specific documents are required for the respective jurisdictions: Chinese Mainland: Registration certificate (中華人民共和國醫療器械注冊證) issued by National Medical Products Administration (NMPA), and, where applicable, associated Product Technical Requirements (產品技術要求). Australia: Australian Register of Therapeutic Goods Certificate(s) issued by Australian Therapeutic Goods Administration (TGA). The associated Declaration of Conformity (DoC) shall be submitted upon request. Canada: Medical Device Licence issued by Health Canada (HC). Member countries of European Union: (i) EU MDR certificate(s) and associated Declaration of Conformity (DoC) OR; (ii) EU MDD certificate(s), MDD extension declaration letter signed as per Regulation (EU) 2023/607, and associated Declaration of Conformity (DoC). Japan: Certificate issued by Ministry of Health, Labour and Welfare Government of Japan (MHLW) or Registered Certification Body. Singapore: Record of approval from website of Singapore Health Sciences Authority (HSA). South Korea: Medical Device Product Licence issued by Korea Ministry of Food and Drug Safety (MFDS). The Certificate of Free Sale shall be submitted upon request. United States of America: 510(k) (Premarket Notification) or PMA (Premarket approval) or De Novo issued by U.S. Food and Drug Administration (FDA). A Certificate to Foreign Government (CFG) shall be submitted upon request. D003 A duly completed and signed Essential Principles Conformity Checklist (Form MD-CCL) shall be submitted to the MDIS platform. Alternatively, an Essential Requirements (ER) Checklist or General Safety and Performance Requirements (GSPR) Checklist, prepared in accordance with relevant 15 / 20 GN-02:2026 (E)(Ed. 1.0) Item Explanation European Union (EU) Medical Device directives or regulations, may be submitted in lieu of the MD-CCL. This alternative is acceptable only if a valid set of marketing approval certificates from the EU is submitted as part of the submission. If ER or GSPR Checklist is submitted in lieu of MD-CCL checklist, applicant shall declare that the device in Part C fully complies with all the relevant clauses stipulated under the Essential Principles of Safety and Performance of Medical Devices as required under the Medical Device Administrative Control System. Applicant shall undertake to provide the necessary evidence to demonstrate the compliance within two weeks upon request. E001 The “Novo Lane” is established to prioritise the processing of eligible innovative medical device applications. To qualify as an innovative medical device under “Novo Lane”, at least one of the following criteria shall be satisfied: (i) Device with unique feature and without existing equivalence on the market (“First-of-its-kind”) (ii) Device with a referenced marketing approval obtained under an innovation channel (e.g. “創新器械名錄” in NMPA or de novo approval in FDA) within the preceding 5 years (iii) Device with AI features approved to be marketed within the preceding 5 years (iv) Device with its core technology patented within the preceding 5 years The applicable checkbox(es) shall be selected to indicate qualifying criteria. The checkboxes shall be left blank if the device is not eligible for the “Novo Lane”. Supplementary documents substantiating the selected criteria should be submitted in the designated field. A description of the innovative features and the clinical benefits should be stated in the designated field. Notwithstanding its eligibility for the “Novo Lane”, the device shall be supported by the MDACS Conformity Assessment Certificate submitted in D001 and/or reference marketing approval certificate(s) submitted in D002. E002 The listing application will be processed under the Expedited Approval Scheme provided that all of the following criteria are satisfied: (i) The applicant is an LRP with valid LRP listing number; (ii) There are no reported deaths or serious injury associated with the device, both locally and worldwide; (iii) There are no active recalls, field safety corrective actions or adverse events, both locally and worldwide; and (iv) All devices in the application are supported by two or more valid, independent marketing approvals from the jurisdictions specified in D002. Participation in the Expedited Approval Scheme is initiated by default to facilitate a streamlined review. The checkbox should be selected only if there is an intention to OPT-OUT from the scheme. 16 / 20 GN-02:2026 (E)(Ed. 1.0) Item Explanation E003 Where, to the best of the applicant’s knowledge, the device has been procured by the Hospital Authority within the preceding 12 months, the following information shall be provided in the designated fields: (i) Hospital Authority Purchase Order Number; (ii) Purchase order date; and (iii) Name of supplier on the purchase order.
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9. Medical Devices Procured by the Hospital Authority
9. Medical Devices Procured by the Hospital Authority 9.1 After acknowledgement of the application by the MDD, the applicant is welcome to update the MDD if the device came to be procured by the Hospital Authority. The applicant should update the MDD via MDIS by quoting: (i) Hospital Authority Purchase Order Number; (ii) Purchase order date; and (iii) Name of supplier on the purchase order.
10. Enquiries 10.1 Enquiries concerning this document and the Medical Device Administrative Control System 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 Department of Health. Definitions and Abbreviations for the Medical Device Administrative Control System. Guidance Notes GN-00. 11.2 Department of Health. Overview of the Medical Device Administrative Control System. Guidance Notes GN-01. 11.3 Department of Health. Guidance Notes for Adverse Event Reporting by Local Responsible Persons. Guidance Notes GN-03. 11.4 Department of Health. Classification of General Medical Devices. Technical Reference TR-003. 17 / 20 GN-02:2026 (E)(Ed. 1.0) 11.5 Department of Health. Essential Principles of Safety and Performance of Medical Devices. Technical Reference TR-004. 11.6 Department of Health. Additional Medical Device Labelling Requirements. Technical Reference TR-005 11.7 Department of Health. Software Medical Devices and Cybersecurity. Technical Reference TR-007 11.8 Department of Health. Artificial Intelligence Medical Devices (AI-MD). Technical Reference TR-008 11.9 Department of Health. Code of Practice for Local Responsible Persons. Code of Practice COP-01 18 / 20 GN-02:2026 (E)(Ed. 1.0)
12. Sample MDS-01 for reference Additional information of medical device system “ABC Medical / VGOOD PMS-123” Monitoring Systems, Physiologic comprises a physiologic monitor (item 1), a remote control keyboard (item 2), a module rack (item 3) and various physiological and printing modules (item 4 to 9). The remote control keyboard and the module rack are connected directly to the physiologic monitor. Users can plug into the module rack any physiological modules (items 4 to 8) to enable the physiologic monitor to display, record and alarm respective physiological parameters depending on patient needs. A printing module (item 9) is available to provide print-out of physiological parameters. Details of the functions of the medical device system and respective component medical devices can be found in the Operator’s Manual. AMDNS Term / Device Description AMDNS Code Identifier Functions/Purpose 1. Monitors, Bedside, Physiologic, Modular 20171 PMS-VDU For displaying, recording, alarming of physiological parameters, depending which modules are being plugged into the module rack (item 3) 2. Keypads, Computer /Computerised System, Remote Control 22858 PMS-RCK For users to enter data and commands to control the functions of the physiologic monitoring system 3. Physiologic Monitor Module Housings 22856 PMS-SMR For the connection of modules (housing of modules) to the patient monitor. The maximum number of modules that can be plugged into the rack is 8 4. Physiologic Monitor Modules, Electrocardiography 20771 PMS-ECR Plugged into the module rack (item 3), for measuring patient ECG and respiration rate (using impedance method) to identify episodes of 19 / 20 GN-02:2026 (E)(Ed. 1.0) AMDNS Term / Device Description AMDNS Code Identifier Functions/Purpose arrhythmia and apnoea 5. Physiologic Monitor Modules, Pulse Oximetry 20781 PMS-SPO Plugged into the module rack (item 3), for measuring transcutaneously oxygen concentration (SpO 2 ) in arterial blood (using spectrophotometry method). 6. Physiologic Monitor Modules, Noninvasive Blood Pressure 20773 PMS-NBP Plugged into the module rack (item 3), for measuring blood pressure non-invasively (using oscillometric method) 7. Physiologic Monitor Modules, Invasive Blood Pressure 20772 PMS-IBP Plugged into the module rack (item 3), for measuring invasive blood pressure (direct method) 8. Physiologic Monitor Modules, Temperature 20779 PMS-TMP Plugged into the module rack (item 3), for measuring patient’s body temperature 9. Paper, Recording 15639 PMS-PRN Plugged into the module rack (item 3), for providing print-out of patient related data from various physiological modules (items 4 – 8) 20 / 20 GN-02:2026 (E)(Ed. 1.0)
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