Department of Health | Medical Device Division - Medical Device Listing Application

Medical Device Listing Application – Useful Information

The Medical Device Administrative Control System (MDACS) is in place to ensure that medical devices supplied in Hong Kong meet the requirements on safety, quality and performance. To apply for listing under the MDACS, a medical device must be proven to have met the requirements under the Essential Principles of Safety and Performance of Medical Devices that are adopted internationally.

Note: The below provides certain useful information on medical device listing application for Local Responsible Person’s (LPR's) reference only. The LRP shall always refer to relevant Guidance Notes and Technical References of MDACS for latest requirement(s). For enquiries, please contact the Medical Device Division.

About Manufacturer
1. (A001) The name and address of the manufacturer shall be consistent with the submitted marketing approvals.
2. (A001) The name of the manufacturer shall be consistent across the designation letter, marketing approval, Quality Management System Certificate, and labels.
3. (A002) Unless the Manufacturer is a Local Manufacturer, a Hong Kong Business Registration (BR) need not be submitted.
4. (A003) If the device only holds a registration certificate issued by the National Medical Products Administration (NMPA), the Local Responsible Person (LRP) may submit the medical device production license issued by NMPA in lieu of an ISO 13485 certificate.
5. (A004) If the manufacturer is not acting as the Local Responsible Person (LRP), the manufacturer shall issue a Designation Letter to the LRP in accordance with the sample in Guidance Notes GN-01 and having models and product codes specified.
About the Local Responsible Person (LRP)
1. (B001) The name and address of the LRP shall be consistent with the BR.
2. (B001) The phone numbers provided by the LRP for public enquiries and 24-hour emergency contact (including the phone number shown on the Special Listing Information) should be a local Hong Kong phone number.
3. (B002) The LRP designation letter shall be issued by the manufacturer following the sample in Guidance Notes GN-01 and having models and product codes specified.
4. (B002) The LRP's name in the designation letter shall be consistent with the BR.
5. (B004) The LRP's documented procedures shall follow Guidance Notes GN-01 and Code of Practice COP-01 and reflect the LRP's actual business operations. Direct copying sections from Guidance Notes that is not consistent with actual business operations should be avoided.
6. (B004) The LRP should submit both documented procedures and relevant record forms.
7. (B006) LRP may input the previous application number (ANXXXXXX) in B006 if the same application had been previously unsuccessful in completing medical device listing.
8. When applying for medical device listing for the first time, the LRP shall also complete the LRP vetting application. If the LRP vetting application is unsuccessful, all related device applications under vetting will not be further processed.
9. The LRP's individual accounts in MDIS shall include at least one valid local Hong Kong phone number.
About Device Information
1. (C001) The model and product code input by the LRP shall be consistent with the designation letter and marketing approval; use comma separation where needed.
2. (C001) Use of MDS-01 or MDS-02 as a substitute to inputting device information on the application form will not be accepted. Device information shall be inputted in MDIS by the LRP.
3. (C002) Content of MDS-01 and MDS-02 (including model and product code) will not be considered as Listing information nor be shown on the Listing Certificate.
4. (C003) If no suitable Asian Medical Device Nomenclature System (AMDNS) code is found, the LRP may provide codes from other nomenclature systems (e.g. Global Medical Device Nomenclature (GMDN)) and advise AMDNS codes attempted.
5. (C008) The LRP shall specify device classification and applicable rules according to Technical References TR-003 or TR-006, citing the rule number or clause.
  Examples:
  - General medical device: “Rule 10(ii). Active devices intended to emit ionizing radiation and intended for diagnostic and/or interventional radiology, including devices which control or monitor such devices, or those which directly influence their performance, are in Class III.”
  - IVD device: "Clause 8.1.1 – Devices intended to be used to detect the presence of, or exposure to, a transmissible agent in blood, blood components, blood derivatives, cells, tissues or organs or any of their derivatives, in order to assess their suitability for transfusion or transplantation or cell administration — Class D"
About Labelling
1. (C005) The intended use entered into MDIS shall be consistent with those in labels and marketing approval documents.
2. (C013) The labelling document submitted by LRP shall be properly categorized in MDIS as IFU (Instructions for use) / Label / Special Listing Information / Product Image, etc.
3. (C013) Label submitted shall be the same version as the submitted Marketing Approval. For instance, EU-approved devices shall possess CE mark.
4. (C013) If more than one marketing approvals are submitted, labels for each version shall be prepared. The LRP shall specify the one being marketed in Hong Kong.
5. (C013) Currently, Medical Device Division does not accept labelling materials that are not approved by regulatory authorities other than those approved by Conformity Assessment Bodies (except for translations). LRP shall submit both original and translated label versions for record.
6. For IFU translated from languages other than Chinese or English, the applicant shall demonstrate that the concerned IFU is properly translated. Generally speaking, the following are acceptable:
  1. The translated version(s) is/are covered by the referenced marketing approval, or
  2. The translation was conducted by a service provider certified with ISO 17100 or equivalent, or
  3. A declaration administered by a notary public indicating that the version(s) concerned is an accurate representation of the original IFU.
Others
1. (D001) LRP shall submit marketing approval(s) for the medical device. The marketing approval(s) shall (i) specify manufacturer’s name, manufacturer’s address, (ii) correspond to labelling information submitted under (C005) and (C013), and (iii) specify all model name(s) and, where available, product code(s) under the listing application.
  1. If model name(s) and product code(s) cannot be verified on the marketing approval documents, the LRP shall submit additional supporting documents such as free sale certificates issued by the same regulatory authority covering all model name(s) and product code(s) under the listing application.
  2. Marketing approval(s) issued by one regulatory authority covering all of the above is required. In other words, model name(s) and product code(s) which could only be fully covered by marketing approvals issued by two different regulatory authorities would not be accepted.
2. (D001) LRP shall submit the conformity checklist according to Guidance Notes GN-02 or GN-06. Medical Device Division accepts EU-approved devices using the Essential Principles Declaration of Conformity and designated documents in lieu. [Designated documents mean Essential Requirements Checklist or General Safety and Performance Requirements Checklist]
3. If no appropriate Attachment Tag could be found on MDIS, the LRP may prepend the Item Codes in Guidance Notes GN-02 or GN-06 Clause 7 to file names filename (e.g. adding [A002_] before BR certs: A002_ManufacturerBR.pdf).
4. If the LRP is delisted from MDACS, all associated device listings will also be delisted simultaneously. Nevertheless, the delisted LRP shall continue be responsible for all the post market surveillance and vigilance obligations for the delisted medical device(s) stipulated in the Code of Practice COP-01: Code of Practice for Local Responsible Persons and Guidance Notes GN-03: Adverse Event Reporting by Local Responsible Persons for products supplied to users.
5. LRP should refer to the list of Documents that shall be duly signed as follows:
  1. (B002) LRP designation letter
  2. (D001) Essential Principles Declaration of Conformity
  3. (D001) Essential Principles Conformity Checklist
  4. (C017/C018) Clinical Evaluation / Performance evaluation Report
  5. (C010) Post-Market Surveillance Summary

The Local Responsible Person (LRP) is advised to include, at a minimum, the following documents in the application submission for listing of a medical device under MDACS via the Medical Device Information System (MDIS). The LRP must ensure that the application and all the associated submissions are properly prepared before they are submitted. Furthermore, the LRP has the obligation to submit further information (including original or certified true copies of documents) or further labelling samples related to the application if this is requested by the Medical Device Division. Failure of the LRP to provide information requested by the Medical Device Division may result in closure of the listing application.

Documents Essential to Medical Device Listing Application under MDACS

Last updated: 25 February 2026