As a leading player in the medical device industry, Qualtech Consulting Corporation keeps a close eye on the updates from the Medical Device Administrative Control System (MDACS). In this article, we explore some key changes in MDACS that impact medical device agencies and their regulatory system.

Exclusion of Particular Devices from MDACS
Excluding Custom-Made Medical Devices

One of the notable updates recently is the decision to exclude custom-made medical devices from the scope of MDACS. This decision has far-reaching implications for manufacturers and medical device industries. Since 2 April 2024, Guidance Notes GN-00 has been updated for the relevant definitions and Clause 3.2.1 of the Guidance Notes GN-01 on the exclusion of custom-made medical devices.

Understanding the New Definitions

The term "Personalised Medical Device" refers to medical devices intended for a particular individual. These could be either a Custom-Made, Patient-Matched, or Adaptable Medical Device. Each type has specific requirements, as detailed in the updated Guidance Notes GN-00.

What distinguishes a Custom-Made Medical Devices from the other Personalised Medical Device types is its intention for the sole use of a particular individual, intended to address the specific anatomo-physiological features or pathological condition of the individual for whom it is designed for. While Adaptable Medical Devices are mass-produced and Patient-Matched are typically produced in a batch through a process that is capable of being reproduced.

GN-01 explains that Personalised Medical Devices, unless they are Patient-Matched or Adaptable Medical Devices, are not to be included into the current scope of the MDACS. Thus, Custom-Made Medical Devices are excluded.

Excluding Non-Clinical Purposed Devices

Aside from custom-made medical devices, starting from 13 May 2024, Hong Kong Medical Device Division (HK MDD) has updated Guidance Notes GN-01 to also exclude devices that are intended for non-clinical purposes, such as:

(a) Research Use Only (RUO); or

(b) teaching purpose only; or

(c) general laboratory use only; or

(d) presentation or demonstration purposes only in trade fairs, exhibitions or demonstrations.

This update takes immediate effect, and thus Non-Clinical Purposed Devices are excluded from the current scope of MDACS.

Acceptance of Marketing Approvals from Health Sciences Authority (HSA)

HK MDD has also recently announced the acceptance of marketing approvals obtained from the HSA of Singapore starting from 2 April 2024. This update is of great significance for medical device manufacturers who have obtained the HSA approvals, as support to the compliance "Essential Principles of Safety and Performance of Medical Devices" (Technical Reference: TR-004) under MDACS.

With this, the following Guidance Notes and Application Forms have also been updated.

• Guidance Notes    : GN-02, GN-04, GN-06
• Application Form   : MD101, MD102

If there are approvals from any of the GHTF founding members, namely Australia, Canada, the European Union (EU), Japan and the USA; Mainland China, South Korea and/or Singapore, the Local Responsible Persons (LRPs) shall tick the appropriate boxes under index D1 of the submission folder and a copy of the approval documents shall be provided.

The list of all updated guidance (Department of Health | Issued Documents under MDACS (mdd.gov.hk)) and forms (Department of Health | Medical Device Division - Forms (mdd.gov.hk)) can be obtained from MDD’s website as linked.

Stay Updated!

The recent updates on MDACS have made a significant impact on the medical device industry. It is crucial for medical device manufacturers and agencies to stay updated with these changes to ensure compliance and make informed decisions.

Talk to us

Connect with us today to unlock your medical device potential and stay tuned for more updates from Qualtech.

 

 

References:

• MDD Announcement: Exclusion of Custom-Made Medical Devices from MDACS
• MDD Announcement: Exclusion of Non-Clinical Devices from MDACS
• MDD Announcement: Acceptance of Marketing Approvals from Health Sciences Authority (HSA)
• Department of Health | Issued Documents under MDACS (mdd.gov.hk)
• Department of Health | Medical Device Division - Forms (mdd.gov.hk)