Primary Evaluation Roadmap: What It Changes for Device Companies

1. Key takeaways

Primary evaluation means that Hong Kong, China assesses and approves the safety and efficacy of a medicinal product or device on the basis of clinical data of its own, without depending on a prior approval issued by an overseas regulator. The roadmap was announced on 26 June 2025 together with the CMPR establishment timetable, is implemented in phases from 2026, and reaches full implementation in 2030. The first phase covers extension applications for registered products with chemical and biological elements: new indications, new doses, new usage and dosage, and new dosage forms. For device companies the meaning is structural: the Hong Kong, China role shifts from verifier of evidence to evaluator of evidence, and the room to borrow a reference approval narrows accordingly.

Nothing in the roadmap changes device obligations today. What it changes is the value of a strategy built entirely on a foreign approval, because that strategy assumes a verifier on the other side of the desk. The transition period is therefore best used to accumulate the kind of evidence an evaluator will want, which is local clinical data and a defensible performance story.

The GRZAN view. The companies that prepare for primary evaluation while listing under MDACS will pass through the 2030 boundary without a filing gap; those that wait will queue.

2. Legal basis

Roadmap and phasing. The Legislative Council Panel on Health Services background brief for the meeting of 10 April 2026, document CB3-261-4, deals with phased implementation and full implementation in 2030 at paragraphs 13 to 14. The Department of Health symposium press release P2026020300240 of 3 February 2026 reports the Director of Health on the scope of the first phase and on 2026 as a milestone. The Commerce and Digital policy document on the establishment of CMPR and the roadmap for primary evaluation, paper 41, records at paragraph 9 the launch of the roadmap in June 2025 and phased implementation from 2026, with paragraph 20 adding detail. The Finance Committee reply on the 2026-27 Estimates, question 2202, records the 150 working days processing target in its section on the 1+ mechanism.

Scope of the first phase is narrow by design. Only extension applications for already registered products with chemical and biological elements are included. Devices are not in the first phase, although the CMPR remit expressly covers device regulation and the government is committed to device legislative proposals in 2026.

3. Expert insights

The first phase is about medicines; devices follow. The first phase is limited to extension applications for registered chemical and biological element products, and devices are not included. But the CMPR remit expressly includes medical device regulation, and the legislative proposals are due in 2026. Device entry into self-standing review is therefore a question of timing rather than of principle, and the practical planning assumption should be that it happens within the roadmap horizon.

The value curve of a reference approval will change. MDACS today relies heavily on approvals from reference jurisdictions, and that reliance is precisely what marks it as not a primary evaluation system. Under primary evaluation the weight shifts to local clinical data and local expert assessment. A filing strategy that consists of a foreign approval plus a translation will not survive that shift intact, and the cost of retrofitting clinical evidence after the event is considerably higher than collecting it during the transition.

The 1+ mechanism provides an observable sample. In medicines, the 1+ mechanism took effect on 1 November 2023 and was extended to all new drugs on 1 November 2024. As at 28 February 2026, the Department of Health had received more than 770 enquiries from 197 pharmaceutical companies, and had set a target of 150 working days to process a registration application, excluding time taken by applicants to respond. Efficiency building in the device sector is likely to follow a similar path, and the 150-day figure is the only published benchmark of its kind at present.

For mainland companies the shift cuts both ways. On one side, self-standing review means an NMPA approval no longer carries a product through by association. On the other, the official position is that products manufactured anywhere, including the Chinese mainland, may apply under the mechanism, and the Greater Bay Area international clinical trial institute will serve as a platform for clinical research and development support. Mainland manufacturers therefore hold a geographic advantage in generating local clinical data, which is exactly the input that primary evaluation rewards.

4. Practical recommendations

• Do not treat a reference approval as a long-term moat. Complete listings quickly inside the present window while starting a local clinical data plan in parallel, so the two tracks converge before 2030.
• Assess the Greater Bay Area clinical platform. Evaluate the feasibility of generating local clinical data through the Greater Bay Area international clinical trial institute, as preparation for primary evaluation.
• Use 150 working days as an efficiency reference. Plan submission rhythm against the published medicines target, on the understanding that this is a practical estimate for devices, where no comparable published figure exists.
• Join the consultation. The government has said it will consult the industry and stakeholders before submitting the bill, so participation through trade associations is the channel through which device-specific concerns reach the draft.
• Assign an owner for the roadmap. Give one person responsibility for tracking milestones, because the changes arrive through unrelated documents rather than through a single announcement.

5. Verification checklist

• □ Primary evaluation recorded as phased from 2026 with full implementation in 2030.
• □ First phase scope confirmed as extension applications for registered chemical and biological element products.
• □ Dependence of the product line on reference approvals assessed.
• □ Availability of the Greater Bay Area clinical platform researched.
• □ Membership of at least one Hong Kong, China industry association or consultation channel in place.
• □ Quarterly review of roadmap progress established.

Regulatory information verified as at 29 October 2026 against the official sources listed under legal basis; where those sources are updated, the latest published version prevails.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for Hong Kong, China. Our team manages Medical Device Administrative Control System (MDACS) listings, coordinates import licensing, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com