Regulatory News

Overview of Changes

The updated version of the "中成藥說明書指引 (供業界參考)" (Guidelines for Chinese Patent Medicine Inserts (for Industry Reference)) introduces one new item to Appendix II, detailing specific warnings and precautions for products containing ethanol as a solvent.

Key Changes

• New Entry in Appendix II: A new item (11) has been added to Appendix II, titled "酊劑、酒劑、以乙醇為溶劑的搽劑、貼劑和貼膏劑、含乙醇的洗劑和流浸膏劑中成藥" (Tinctures, wines, external liniments, plasters, and patches with ethanol as a solvent, and washes and concentrated liquid extracts containing ethanol in Chinese patent medicines).
• Specific Precaution for Ethanol-Containing Products: For products falling under the new entry, the following warning must be displayed under the "使用該成藥時須採取的預防措施" (Precautions when using this medicine) section: "對酒精過敏者禁用" (Contraindicated for those allergic to alcohol).

Suggestions for SOP Updates

• Update Appendix II in SOP: The company's Standard Operating Procedure (SOP) for the preparation of Chinese patent medicine inserts needs to be updated to include the new item 11 in Appendix II.
• Incorporate New Precaution: The SOP should specify that for any Chinese patent medicine that is a tincture, wine, external liniment, plaster, patch with ethanol as a solvent, or a wash/concentrated liquid extract containing ethanol, the following warning must be included in the "Precautions when using this medicine" section: "對酒精過敏者禁用".

Overview of Changes

The new version of the Guidelines on package inserts of proprietary Chinese medicines (pCms) introduces a new contraindication for specific dosage forms containing ethanol.

Key Changes

• A new contraindication has been added for pCms in the following dosage forms:

  • tinctures
  • medicinal wines
  • liniments, patches, and cataplasms using ethanol as solvent
  • lotions and liquid extracts containing ethanol

  This contraindication states: "Contraindicated in individuals with alcohol allergy."

Suggestions for SOP Updates

• Update the SOP section pertaining to contraindications to include the new contraindication for pCms containing ethanol in specific dosage forms.
• Add a new entry to Schedule I (or an equivalent section in the SOP that details contraindications) listing the affected dosage forms and the specific contraindication for alcohol allergy. The new entry should reflect the wording: "pCms in the following dosage form: (i) tinctures; (ii) medicinal wines; (iii) liniments, patches, and cataplasms using ethanol as solvent; and (iv) lotions and liquid extracts containing ethanol. Contraindicated in individuals with alcohol allergy."

Overview of Changes

The latest version of the Guidance Notes GN-06 (GN-06:2026(E)) introduces several significant updates compared to the previous version (GN-06:2025(E)). These changes include the addition of new sections related to compliance with the Prevention of Bribery Ordinance and devices procured by the Hospital Authority. Several existing clauses and appendices have been revised, and new technical references have been incorporated. The document format has also been updated.

Key Changes

• New Sections Added:
  • Clause 7: Compliance with the Prevention of Bribery Ordinance: This new clause explicitly states that applicants and their representatives must not offer advantages to government officers in connection with their applications or dealings with government departments.
  • Clause 9: Devices Procured by the Hospital Authority: This new clause details requirements for reporting if a device has been procured by the Hospital Authority within the past 12 months, including specific information such as the Purchase Order Number, Purchase order date, and Name of supplier.
• Revised Clauses and Content:
  • Appendix I: This appendix has been deleted in the new version.
  • References: New technical references TR-007, TR-008, and COP-01 are now included. Several other clauses (1.1, 2.1, 3, 3.1.1, 3.2.1, 4, 4.1, 5.1.1, 5.2.1, 5.3, 5.3.1, 5.4.1, 6.4, 8, 10) have been revised, indicating updates to the content within these sections.
  • Guide to Application Form MD102 (Clause 8): The structure and specific guidance within this section have been significantly revised to reflect updated requirements for completing the form, including detailed explanations for items A001-C018 and new items D001-E003. This includes changes in how QMS certificates are listed, specific requirements for marketing approval documents from different jurisdictions, and new sections for "Innovative Medical Device" and "Expedited Approval Scheme".
  • Table of Contents: The numbering and content of the Table of Contents have been updated to reflect the addition of new clauses and renumbering of existing ones. For example, Clause 7 in the old version is now Clause 8 in the new version, and Clause 9 (Enquiries) is now Clause 10.
• Document Format: The document format has been updated in the new version.

Suggestions for SOP Updates

• Integrate New Clauses: The company's SOPs should be updated to incorporate the requirements outlined in the newly added Clause 7 (Compliance with the Prevention of Bribery Ordinance) and Clause 9 (Devices Procured by the Hospital Authority). This includes ensuring that employees and agents are aware of and adhere to the anti-bribery provisions and that procedures are in place to capture and report Hospital Authority procurement information for relevant applications.
• Update References: Ensure all internal SOPs and training materials that reference GN-06 refer to the latest version and incorporate the new technical references (TR-007, TR-008, COP-01) where applicable.
• Revise Application Process Guidance: Review and update SOPs related to the application submission process to align with the detailed changes in Clause 8 (Guide to Application Form MD102). This will require a thorough examination of each item (A001-E003) to understand the new documentation requirements, accepted QMS certificates, marketing approval specifics, and new criteria for innovative devices and expedited review.
• Remove Obsolete Information: Remove any references or procedures within SOPs that are based on the deleted Appendix I (Sample Application Form for Listing).
• Training and Awareness: Conduct training sessions for the regulatory affairs team to ensure they are fully aware of all changes in GN-06:2026(E), particularly the new clauses and the detailed requirements in the revised Guide to Application Form section.

Overview of Changes

The new version of the guidance notes (GN-02:2026(E)) introduces several significant changes compared to the previous version (GN-02:2025(E)). These include the addition of new clauses related to compliance with the Prevention of Bribery Ordinance and medical devices procured by the Hospital Authority, revised sections on application procedures, appeals, and references, and the deletion of Appendix I. Additionally, there are updates to the listed references and sections within the document.

Key Changes

• New Clause 7: Compliance with the Prevention of Bribery Ordinance: A new section has been added to explicitly state the requirement for applicants to comply with the Prevention of Bribery Ordinance (Cap. 201) and to not offer any advantages to government officers.
• New Clause 9: Medical Devices Procured by the Hospital Authority: A new clause has been introduced detailing how applicants can update the Medical Device Division (MDD) if their device has been procured by the Hospital Authority within the past 12 months, requiring specific purchase order details.
• Revised Section 1.1 (Introduction): The list of referenced documents has been updated to include "Code of Practice for Local Responsible Persons (Code of Practice COP -01)" and documents issued by the Medical Device Division (MDD). It also specifies that TR-005 is "Additional Medical Device Labelling Requirements" and GN-00 is "Definitions and Abbreviations for the Medical Device Administrative Control System."
• Revised Section 3.2.1: The wording has been slightly adjusted to "Applicants should take into consideration" instead of "The applicant must take into consideration."
• Revised Section 4.1: The referenced guidance notes for LRP requirements have been updated to include "Guidance Notes GN-03, and Code of Practice COP -01."
• Revised Section 5.3 (Time for vetting and processing an application): The clause has been updated to clarify that the 12-week period commences upon submission of the application and all required supporting information, including any requested during the assessment. It also explicitly states that failure to provide requested information within the timeframe will result in the closure of the application.
• Revised Section 5.4 (Notification of approval or rejection of application): The wording has been updated to state that notification of the result will be issued to the applicant. It also clarifies that non-compliance with stipulated conditions may result in delisting from the MDACS.
• Deleted Appendix I: Appendix I, which previously contained the "Sample Essential Principles Declaration of Conformity," has been removed.
• Revised Section 8 (Guide to Application Form MD101): This section has undergone substantial revisions:
  • New Sub-clauses 8.1, 8.2, and 8.3: These new sub-clauses address the validity of submitted certificates, the requirement for certified copies when authenticity is questioned, and the acceptable languages and translation requirements for submitted documents.
  • Revised Item A001: Clarifies that the Local Responsible Person (LRP) must be a legal person incorporated in Hong Kong OR a natural or legal person with a registered place of business in Hong Kong.
  • Revised Item A003: Significantly updates the accepted Quality Management System (QMS) certificates to include GB/T 42061, Medical Device Manufacturing License (NMPA), MDSAP, and KGMP, along with specific conditions for their submission and associated marketing approvals.
  • Revised Item B001: Updates the contact information requirements to include "Contact Telephone for Public Enquiries," "Mobile Telephone for Urgent Use (24 hours)," and "Company Contact," and specifies that phone numbers shall be valid Hong Kong local numbers.
  • Revised Item B003: Rephrased the conditions for LRP listing number exemptions and added a requirement for compliance with other relevant MDD documents.
  • Revised Item C002: Clarifies that product models and codes must be explicitly specified in the MDACS Conformity Assessment Certificate or reference marketing approval certificates and that only devices within the MDACS listing scope should be stated. It also notes that only information in C002 will be displayed on the List of Medical Devices and Listing Certificate.
  • Revised Item C004: Now requires the inclusion of other nomenclature codes like GMDN and NMPA Classification Code.
  • Revised Item C006: Emphasizes that the intended use statement must be supported by the MDACS Conformity Assessment Certificate, marketing approval certificates, Clinical Evaluation Report, and Risk Analysis Report.
  • Revised Item C009: Adds specific checkboxes for "SaMD" (Software as a Medical Device), "SiMD (Software in a Medical Device)", and "AI-MD" (Artificial Intelligence Medical Device), referencing new Technical References TR-007 and TR-008.
  • Revised Item C010: Mandates the submission of QMS certificates covering all specified manufacturing sites, and that the certificate number and expiry date be entered.
  • Revised Item C011: Updates the disclosure of historical information to include safety alert case numbers and adverse event case numbers in specific formats (HK-XXXX-XXXX, NL-XXXX-XXXX, AE-XXXX-XXXX) if created in MDACS.
  • Revised Item C013: Specifies that for devices intended for laypersons, IFUs must be in both English and Chinese. It also requires a rationale for non-provision of IFUs and clarifies the submission of electronic labelling.
  • Revised Item C014: Adds the Telecommunications Ordinance (Cap. 106) to the list of potentially applicable statutory requirements.
  • Revised Item C015: Reorganizes and expands the requirements for Risk Analysis, List of Standards, and Non-clinical Studies, with specific mention of ISO 14971, cybersecurity documentation (TR-007), and AI documentation (TR-008).
  • Revised Item C016: Provides a more detailed step-by-step explanation of the clinical evaluation process.
  • Revised Item D001 and D002: Updates the requirements for MDACS Conformity Assessment Certificates and reference marketing approvals, with specific documentation requirements for various jurisdictions (Chinese Mainland, Australia, Canada, EU, Japan, Singapore, South Korea, USA).
  • Revised Item D003: Clarifies that an ER or GSPR Checklist is acceptable only if a valid set of marketing approval certificates from the EU is submitted.
  • New Items E001, E002, E003: These new items address "Innovative Medical Device," "Expedited Approval Scheme," and "Medical Devices Procured by the Hospital Authority," respectively, introducing new criteria and processes for specific types of applications.
• Revised Section 10 (Enquiries): The numbering has been updated to 10.1.
• Revised Section 11 (References): The numbering has been updated to 11.1-11.9, and new references to TR-007, TR-008, and COP-01 have been added.
• Revised Table of Contents: The numbering and titles of sections have been updated to reflect the changes in clause numbering and the addition/deletion of sections.

Suggestions for SOP Updates

• Update SOP to reflect new clauses: Incorporate the requirements outlined in the new Clause 7 (Compliance with the Prevention of Bribery Ordinance) and Clause 9 (Medical Devices Procured by the Hospital Authority) into the relevant sections of the SOP.
• Update LRP eligibility and requirements: Revise the SOP to align with the updated requirements for Local Responsible Persons (LRPs) as detailed in revised Section 4.1 and Item A001 and B001/B003 in the application form guide.
• Incorporate updated QMS requirements: Amend the SOP to reflect the expanded list of acceptable Quality Management System (QMS) certificates and their associated submission requirements as per revised Item A003.
• Refine application processing timelines and procedures: Update the SOP to accurately reflect the revised application processing timeframe and the consequence of non-compliance with requests during the vetting process as per revised Section 5.3.
• Incorporate changes in documentation submission: Update the SOP to include the new requirements regarding the language of documents, translation, certified copies, and the submission of electronic certificates/documents as per new Sub-clauses 8.1, 8.2, and 8.3.
• Update the section on device identification: Ensure the SOP aligns with the clarified guidance on stating brand names, models, and product codes in Item C002, including the requirement for explicit mention in conformity assessment or marketing approval certificates.
• Incorporate SaMD, SiMD, and AI-MD requirements: Update the SOP to include the classification and submission requirements for SaMD, SiMD, and AI-MD as per revised Item C009, referencing TR-007 and TR-008.
• Update post-market surveillance and adverse event reporting guidance: Align the SOP with the revised requirements for disclosing historical recalls, adverse events, banning information, and the specific formats for reporting case numbers in revised Item C011.
• Refine clinical evaluation and risk management sections: Ensure the SOP's guidance on clinical evaluation and risk management procedures is consistent with the more detailed explanations in revised Items C015 and C016.
• Update marketing approval documentation requirements: Revise the SOP to reflect the detailed and jurisdiction-specific requirements for marketing approval documents as outlined in revised D001 and D002.
• Reflect removal of Appendix I: Ensure any SOP references to the "Sample Essential Principles Declaration of Conformity" or Appendix I are removed or updated.
• Incorporate guidance on Innovative and Expedited Devices: If relevant to the company's operations, update the SOP to include the processes and criteria for qualifying for "Innovative Medical Device" (E001) and the "Expedited Approval Scheme" (E002).
• Update referenced documents: Ensure all internal SOPs referencing GN-02 are updated to point to the new version and that any internal references to superseded or deleted documents are removed or updated accordingly.
• Review and update any SOP sections related to translation: The detailed requirements for translations in Sub-clause 8.3 necessitate a review of any SOPs that involve document submission in non-English/Chinese languages.

Overview of Changes

The new version, GN-00:2026-1(E), introduces a significant update to the definition of "Medical Device" by incorporating a reference to an "Appendix 1" which lists additional items treated as medical devices under the MDACS. Additionally, there are revisions to how various definitions are presented and numbered, reflecting structural and organizational changes within the document. The references section has also been updated to reflect newer versions of GHTF and IMDRF documents.

Key Changes

• Addition of Appendix 1: A new appendix titled "Appendix 1 Items Specified for the Purpose of 2.38 (b)" has been added. This appendix lists "Injectable dermal fillers or mucous membrane fillers" as items treated as medical devices under MDACS.
• Revised Definition of Medical Device (2.38): The definition of "Medical device" in section 2.38 has been restructured. It now explicitly includes a sub-clause "(b) any items listed in Appendix 1". This integration of the appendix is a major change.
• Renumbering of Definitions: The numbering of definitions related to "Medical Device" has been updated. For instance, the original section 2.38 "Medical device" is now followed by a new section 2.39 "According to the characteristics and nature, medical device can be classified into at least the following different types:". This has caused a cascading effect of renumbering for subsequent definitions up to section 2.69.
• Revised References: Reference 5.2 has been updated from "Global Harmonization Task Force: Information Document Concerning the Definition of the Term “Medical Device”. Final Document SG1-N29R16:2005." to "Global Harmonization Task Force: Definition of the Terms ‘Medical Device’ . Final Document GHTF/SG1/N071:2012 .".

Suggestions for SOP Updates

• Update Definition of "Medical Device": The SOP must be updated to reflect the revised definition of "Medical Device" in Section 2.38, specifically including the new sub-clause referencing Appendix 1. This ensures that "Injectable dermal fillers or mucous membrane fillers" are recognized as medical devices under the MDACS.
• Incorporate Appendix 1 Content: The SOP should either directly incorporate the content of Appendix 1 or clearly reference it as an integral part of the definition of a medical device. This means the SOP needs to acknowledge that "Injectable dermal fillers or mucous membrane fillers" are now explicitly within the scope of MDACS.
• Verify Definition Numbering: Due to the renumbering of definitions, the SOP should be carefully reviewed to ensure all cross-references to definitions within the document are updated to reflect the new numbering scheme. For example, any mention of "Use error" (now 2.69) instead of its previous numbering needs to be corrected.
• Update References Section: The SOP's reference section should be updated to include the new version of Reference 5.2, which is now "Global Harmonization Task Force: Definition of the Terms ‘Medical Device’ . Final Document GHTF/SG1/N071:2012 .".

Overview of Changes

There are no substantive changes between the old and new versions of the "Guidance Notes on Registration of Pharmaceutical Products: New Drug Applications". The documents are identical.

Key Changes

N/A

Suggestions for SOP Updates

N/A