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Hong Kong’s MDD Formalizes the Expedited Approval Scheme
Published on January 21, 2022
Trial Scheme Found to Expedite Market Access
On January 17, 2022, the Medical Device Division (MDD) notified all Local Responsible Persons (LRP) of the formalization of the Expedited Approval Scheme that had previously been in trial format. Class II, III, and IV applications are eligible for the expedited scheme and it’s expected to shorten review times and expedite market access for qualifying products. Along with other factors, products will need to be approved by 2 or more Reference countries which includes founding members of the GHTF plus China. The MDD’s formal guidance, GN-02, can be found here.
Expedited Approval Scheme Eligibility
The Expedited Approval Scheme is meant help improve the review process in Hong Kong as review timelines increased the last couple of years. Class II, III, and IV products approved by any 2 of the following markets are eligible for a quicker review:
- United States (U.S. Food and Drug Administration)
- Canada (Health Canada)
- Europe (Member countries of the European Union that have implemented the European Council Directives or Regulations on medical devices)
- Japan (Ministry of Health, Labour and Welfare)
- Australia (The Therapeutic Goods Administration) – Cannot have been approved through the EU Mutual Recognition route.
- China (National Medical Products Administration)
With regard to adverse event requirements, the product must not have:
- any reported deaths or serious injuries associated with the device (locally and worldwide)
- any active recalls, field safety corrective actions or adverse events (locally and worldwide)
It will be very important that the leveraged approvals cover the same make and models being applied for in Hong Kong. Manufacturers will be expected to respond to any MDD queries arising during the review process within 2 weeks.
Unlike during the trial period, manufacturers do not need to provide evidence of a substantially equivalent product already on the market. This change simplifies the application process and benefits manufacturers with innovative or novel products. The MDD has also removed the trial limit on the number of expedited scheme applications one LRP could have at one time.
Leveraging Approvals to Avoid CAB Reviews
Manufacturers can now leverage medical devices approvals from 7 countries as evidence of the Essential Principles (TR-004). This saves time and money by avoiding an additional review by a Conformity Assessment Body (CAB) and includes approvals from the US, Canada, Europe, Australia, Japan, and China. Medical device approvals issued by Korea’s MFDS are also being accepted on a trial basis until the end of 2022. Lastly, the MDD announced that they will accept, on a trial basis, IVD approvals issued by China’s NMPA as evidence of the Essential Principles as well.
Overview of the Hong Kong Registration Process
Medical Device product registration in Hong Kong is managed by the Medical Device Division (MDD) of the Department of Health, formerly known as the Medical Device Control Office (MDCO). Currently, medical device product registration is voluntary in Hong Kong for Class II and above medical devices and Class D IVD devices. While registration is voluntary, the Hospital Authority requires, or gives preference to, registered medical devices during public hospital tenders. Devices can be registered voluntarily through the Medical Device Administrative Control System (MDACS).
While manufacturers can use a Conformity Assessment Body (CAB) to review their technical documents, most manufacturers will leverage a Reference Country approval to expedite market access. ISO 13485 or equivalent is also required and listings are valid for 5 years with an administrative review.
For the latest registration information, including timelines and fees, see our Medical Device Registration page.
Important Documents and Application Forms
|Schemes||Scopes||Guidance Notes||Application Forms|
|Expedited Approval Scheme||Class II/III/IV General Medical Device||GN-02||MD-C2&3&4|
|Accepting marketing approvals obtained from the NMPA||Class II/III/IV General Medical Device||GN-02||MD-C2&3&4|
|Trial schemes for accepting marketing approvals obtained from the NMPA||Class B/C/D In Vitro Diagnostic Medical Device||GN-06||MD-IVD-Trial|
|Trial Scheme accepting marketing approvals obtained from the MFDS||Class II/III/IV General Medical Device||GN-02||MD-C2&3&4-Trial|
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Asia Actual specializes in helping medical device manufacturers grow their sales in Asia with experienced, bi-lingual commercial and regulatory experts on the ground in each market. Contact Asia Actual today with any questions related to medical device registration in Hong Kong or throughout the region.