Registration is not approval: China, Nigeria and the Philippines tighten device rules

China's AI device gate tightens

AI software that diagnoses, triages or guides treatment counts as a medical device in China. It must be registered with the NMPA before it can be sold or used in hospitals. The revised medical device GMP took effect on 1 November 2026, so quality-system obligations now land alongside the registration file. Mid-September 2026 brought two NMPA drafts: one on AI medical devices and one on clinical evaluation of AI multi-disease auxiliary decision-making devices. Analysts read the pair as a layered system: a horizontal lifecycle and algorithm framework plus vertical clinical evaluation rules for complex products.

China's two gates are product approval and data compliance. For hospital buyers, the practical test is now two-part: the registration file and the quality system behind it.

Foreign manufacturers cannot register directly with the NMPA. They must appoint a legal agent in China.

CMDE guidance puts weight on algorithm transparency, training data requirements, algorithm change protocols and cybersecurity. Submissions must document training, validation and test data sources, size, labelling and population. Type testing by an accredited lab comes next, then clinical evaluation, which is usually the longest step.

A 2026 analysis of AI approvals through June 2025 counted 154 since 2020, rising from 9 in 2020 to 45 in 2024, with 79.9% in Class III. Most diagnostic AI lands in that top class, which fixes the reviewer and the timeline.

Registered is not approved

In the United States the vocabulary differs and the trap is the same. 21 CFR 807.39 says registration "does not in any way denote approval of the establishment or its products". The same rule says a representation that creates an impression of official approval because of registration is misleading and constitutes misbranding. Registration is annual: information must be submitted between 1 October and 31 December each year, even if nothing has changed. The public database is refreshed weekly. It returns at most 100 different establishments from any search.

FDA says it issues no device registration certificates at all.

Buyers have to run a second search. Devices@FDA is the catalogue of cleared and approved device information, separate from the registration and listing database. Novel low- or moderate-risk devices may sit in the De Novo database instead. Foreign makers also need device listing and a designated US agent.

For a device that needs premarket clearance, the establishment must wait for that clearance before it can register and list the device.

The Philippines warns on one monitor

Enforcement looks different where the register is the only public trace. Philippines FDA Advisory No. 2026-1680, dated 28 October 2026, warns against buying or using the MEDX automatic upper arm blood pressure monitor, model MD-532. Post-marketing surveillance confirmed the product never went through registration and holds no Certificate of Medical Device Registration, so the agency says it cannot guarantee quality and safety. Under Republic Act No. 9711, manufacture, import, sale, distribution or promotion of a health product without proper authorization is prohibited.

It tells establishments not to distribute, advertise or sell the product until the Product Registration Certificate is issued.

It also asks law enforcement agencies and local government units to keep the product out of their jurisdictions, and urges the Bureau of Customs to restrain its entry. The agency points buyers to its verification portal.

Nigeria sets terms for US-backed supplies

NAFDAC is drawing its own line, and it follows the country of manufacture rather than the label. Mojisola Adeyeye, the agency's director-general, said in a statement on Tuesday that medicines and vaccines under US-Nigeria health agreements will face quality and safety checks. Those products will also be tracked through distribution, she said. US-made products approved by the US FDA may get expedited approval under NAFDAC's regulatory reliance framework. Products not manufactured in the United States will be tested for quality, safety and efficacy by NAFDAC. The supplies are meant to ease shortages of HIV/AIDS commodities after USAID's exit.

Adeyeye said it does not remove NAFDAC's authority to evaluate applications, inspect facilities or run post-market surveillance.

The agency will use its GS1 Track and Trace system to follow those products through the supply chain. Records sit in its Traceability Information System. The same system monitored COVID-19 vaccine distribution during the pandemic and now covers non-COVID vaccines, narcotics, maternal health commodities and newborn care products.

COVID-19 vaccines supplied to Nigeria were tested at the agency's Vaccine, Biologics and Medical Devices Laboratory in Yaba, Lagos, despite their safety declarations by the World Health Organisation, she said.

What happens next

The two NMPA AI guidelines are not in force. Advisory 2026-1680 stands in the Philippines until a certificate is issued, with customs and local governments asked to enforce it.

The NMPA has not said when the AI drafts become final, and NAFDAC has not said which of the US-agreement products are US-made.