How Can Hong Kong and Macao Medical Devices Take the “Green Lane” into the Greater Bay Area? A Complete Guide to the GBA Connect Application Process

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For Hong Kong and Macao medical devices that want to enter the Guangdong-Hong Kong-Macao Greater Bay Area market but have not yet been registered in the Mainland, the “Hong Kong and Macao Drug and Device Connect” (GBA Connect) scheme is an important compliant access channel. Based on the latest policy documents, EVERBIZ explains the legal basis, scope, process and key documents, to help companies and healthcare institutions avoid detours.
How Can Hong Kong and Macao Medical Devices Take the "Green Lane" into the Greater Bay Area? A Complete Guide to the GBA Connect Application Process – Figure 1
The scheme is based on a series of regulations including the Regulations on the Supervision and Administration of Medical Devices, the Provisions for Medical Device Registration and Filing, the Work Plan for Innovative Development of Drug and Medical Device Regulation in the Guangdong-Hong Kong-Macao Greater Bay Area, the Regulations of Guangdong Province on the Administration of Imported Hong Kong and Macao Drugs and Medical Devices in the Nine Mainland Cities of the Greater Bay Area and the Measures for the Administration of the Catalogue of Urgently Needed Imported Hong Kong and Macao Drugs and Medical Devices. It is an innovative regulatory policy arrangement granted to the Greater Bay Area by the state.

2. Core Principles of the Policy

The aim of the policy is clear: centered on promoting public health, it allows clinically urgently needed Hong Kong and Macao medical devices to be used more quickly in designated healthcare institutions in the nine Mainland cities of the Greater Bay Area, improving access to innovative international medical devices. At the same time, review is based on clinical urgency, advanced nature, necessity and reasonableness, simplifying procedures while safeguarding device safety.
How Can Hong Kong and Macao Medical Devices Take the "Green Lane" into the Greater Bay Area? A Complete Guide to the GBA Connect Application Process – Figure 2

3. Who Can Apply, and for What?

Scope of products: medical devices that are urgently needed clinically, already purchased and used in public hospitals in Hong Kong or Macao, and clinically advanced.
Applicants: not every healthcare institution can apply – only designated institutions reviewed and confirmed by the Health Commission of Guangdong Province together with the Guangdong Medical Products Administration and announced to the public. In other words, a company wishing to bring its product in usually needs to work with a qualified designated institution first.

4. The Five-Step Application Process

  1. Online submission: the designated institution submits the application via the enterprise portal of the licensing information system on the Guangdong Smart Food and Drug Administration website; products are divided into “in-catalogue” and “out-of-catalogue”, with different application routes.
  2. Formal review: the Center for Evaluation and Certification of the provincial medical products administration conducts a formal review of the documents; if documents are incomplete, all required supplements are communicated at once within 5 days, and the institution should in principle complete them within 5 working days.
  3. Substantive review: the provincial medical products administration and health commission conduct the review according to the relevant procedures and policies. Institutions applying again for imports they have applied for before may submit simplified documents and benefit from a shortened process.
  4. Decision: if approved, an approval document valid for 1 year is issued; if not, the reasons for refusal are given.
  5. Import and use: import must be completed within the validity of the approval document; after import, the device can be used within the shelf life stated on its label or IFU.

5. Application Documents at a Glance

Requirements differ depending on whether the application is for an “out-of-catalogue” or “in-catalogue” product; the core documents fall into 8 categories:
How Can Hong Kong and Macao Medical Devices Take the "Green Lane" into the Greater Bay Area? A Complete Guide to the GBA Connect Application Process – Figure 3
Some points to note in particular:
  • The informed consent form must state prominently in bold that “this medical device has not been officially marketed in China”;
  • Doctors on the authorized user list who can prescribe and use the device must hold a title of associate senior or above, with title certificates and evidence of relevant training and experience;
  • All foreign-language documents must be accompanied by a Simplified Chinese translation, and those concerning packaging, labels and IFUs must also be notarized;
  • The cover of copies/scans must bear the institution’s official seal, and multi-page documents must bear a cross-page seal.

6. Summary

The GBA Connect policy offers a differentiated access route for innovative overseas medical devices, but the document system is complex and the review demands a high level of logical consistency and expertise – from justifying clinical urgency and assessing risks and benefits to ethics review and departmental management systems, every step needs rigorous compliance logic.
EVERBIZ has long specialized in medical device compliance consulting and can help companies and designated institutions map out the application route, prepare documents and liaise with reviewers, so that innovative products enter the Greater Bay Area market more efficiently and securely. If you have related needs, please contact us.
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How Can Hong Kong and Macao Medical Devices Take the "Green Lane" into the Greater Bay Area? A Complete Guide to the GBA Connect Application Process – Figure 4

About Us

COMPANY INTRODUCTION
EVERBIZ Certification Services (Shanghai) Co., Ltd. (EVERBIZ) is a professional compliance service platform for testing, certification, consulting and training of medical products, dedicated to helping leading medical R&D companies at home and abroad improve their compliance capabilities and competitiveness. The company has offices and branches in Shanghai (China), Hong Kong, Munich (Germany), Salzburg (Austria), Thailand, Vietnam, Singapore and Malaysia, covering nearly 25 industries of compliance products (such as medical devices, new energy, household appliances, lighting, tools, laboratory instruments, machinery, in vitro diagnostics, wireless products and reagents).
How Can Hong Kong and Macao Medical Devices Take the "Green Lane" into the Greater Bay Area? A Complete Guide to the GBA Connect Application Process – Figure 5

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How Can Hong Kong and Macao Medical Devices Take the "Green Lane" into the Greater Bay Area? A Complete Guide to the GBA Connect Application Process – Figure 6
How Can Hong Kong and Macao Medical Devices Take the "Green Lane" into the Greater Bay Area? A Complete Guide to the GBA Connect Application Process – Figure 7

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