If you are deciding which markets to enter and in what order, reliance news matters. A market that will lean on an approval you already hold can move up your list by a year. That is why reliance headlines get read quickly and passed around. It is also why a misread one is expensive. A team that plans a filing around a route that does not exist finds out at submission, and by then the budget is spent.
Five headlines from August to October 2026 were read as device news. None of them changes anything for a medical device. In some cases a device route already exists, under a different instrument, and the headline drew attention away from it. For each one, here is how it was read, what the instrument actually says, and what a device company should do. Each instrument was read in full at the authority's own site.
| Headline | What the instrument covers | What a device company has instead |
|---|---|---|
| Singapore "extends partnerships to speed access" | Two memoranda of understanding and a Malaysian pilot for medicines | Malaysia's existing device reliance programme with Singapore |
| Kenya issues reliance guidelines | Inspections of manufacturing sites for medicines, active ingredients and research organisations | Kenya's January 2025 device reliance routes |
| India "rewrites its IVD rules" | Guidance documents that say they do not change the rules, and a waiver that does not reach new IVDs | Unchanged: new IVDs still need performance data generated in India |
| Mexico recognises Brazilian approvals | Registration of medicines | Mexico's July 2025 abbreviated device route |
| UK cuts Phase 1 trial assessment to 14 days | Low-risk Phase 1 medicines trials. Trials involving a device or IVD are excluded | The standard device clinical investigation process, unchanged |
1. Singapore: "HSA approval now counts in Saudi Arabia, Malaysia and Africa"
The headline. On 17 September 2026 Singapore's Health Sciences Authority (HSA) announced that it was "expanding regulatory reliance and cooperation across Africa, Malaysia and Saudi Arabia". The announcement coincided with the IMDRF meeting HSA was hosting, the main international forum of device regulators. It was widely read as saying that an HSA device approval would now carry weight in all three.
What the instrument says. The release describes four things:
- A memorandum of understanding with the Saudi Food and Drug Authority (SFDA), signed 14 September. It covers "exchange of expertise, information and best practices" and says the two will "explore facilitative regulatory pathways".
- A memorandum of understanding with the African Medicines Agency, signed 16 September. It covers "exploring the appropriate use of HSA's approvals and assessments as references".
- A pilot by Malaysia's National Pharmaceutical Regulatory Agency, from 1 September, "to reference HSA's assessments in its review of medicines".
- A reaffirmed innovation partnership with the UK's MHRA.
None of these sets out a submission route, a fee, a form or a review clock for a medical device. Devices come up only in the IMDRF work programme, which consists of guidance and tools for regulators. HSA's own page files the release under the product types "Therapeutic Products" and "Others", not medical devices.
What a device company has instead. The Singapore–Malaysia route for devices already exists, under Malaysia's Medical Device Authority (MDA), not the medicines agency. It was piloted from 1 September 2025 to 28 February 2026 and now runs permanently. According to HSA's description of it, devices registered with HSA can go through a verification route in Malaysia, with a review expected to take 30 working days instead of 60. It covers Class B to D. It excludes devices that the two authorities classify differently, and Class D devices that contain a registrable drug.
Saudi Arabia published its own device reliance guidance on 9 September 2026, five days before the MoU was signed (SFDA MDS-G30). It names reference authorities in Australia, Canada, the EU, Japan, the UK and the US. Singapore is not on the list. SFDA says the list "may be updated periodically", including to add other IMDRF Management Committee members, and Singapore is one of those members. Until an update names Singapore, an HSA approval is not a reference approval for a Saudi device filing.
What to do. Do not move Saudi Arabia, or any African market, up your list on the strength of an HSA approval. If you already hold one, Malaysia is where it helps now, through MDA's programme. This matters most for startups whose first approval is in Singapore. Only Malaysia will shorten its review on the strength of that approval. Saudi Arabia will not, for now. Check the next revision of MDS-G30 to see whether Singapore has been added.
2. Kenya: "PPB adopts reliance on other regulators' decisions"
The headline. On 9 October 2026 Kenya's Pharmacy and Poisons Board (PPB) posted Guidelines on the Reliance and Recognition of Good Manufacturing Practices (GMP) Decisions. PPB regulates medical devices as well as medicines. Read quickly, "reliance" plus "GMP" sounds like relief from a site inspection for a device manufacturer.
What the instrument says. The document is dated August 2026 (HPT/ISE/GMP/GUD/102, revision 0). Section 1.3 sets its scope: it "applies to the regulation of local and foreign manufacturing sites for Finished Pharmaceutical Products (FPPs), Active Pharmaceutical Ingredients (APIs), and Contract Research Organizations (CROs)". It does not cover medical devices or IVDs. The only device-related words in it are the name of Japan's Pharmaceuticals and Medical Devices Agency, which appears as a reference authority.
What a device company has instead. Kenya's device reliance routes are in a separate, earlier document: PPB's Guidelines on Reliance Mechanisms for Marketing Authorization of Health Products and Technologies (HPT/PER/GUD/091, January 2025). Section 4.5 sets out three routes for devices that hold an approval from a listed reference authority:
- Abridged: Class B, C and D.
- Expedited: Class C and D, with approvals from more than one reference authority.
- Immediate: stated as Class B and C.
The reference list in section 4.4 covers Australia, Canada, Japan, US 510(k) and PMA, EU notified-body certificates under the MDR and IVDR, Ireland, Switzerland and Saudi Arabia. Class A is excluded from reliance altogether. The guideline is not consistent with itself on the immediate route: another section says it is "to be used by Class A&B medical devices".
What to do. Nothing changes for a device filing because of the October document. If Kenya is on your list, plan on the January 2025 routes. Confirm with PPB, through your local agent, which classes the immediate route actually takes before you count on it. Note also that this list includes Saudi Arabia but not Singapore.
3. India: "CDSCO rewrites its IVD rules"
The headline. In 2026 CDSCO, India's regulator, published a run of IVD documents: a draft import guidance, a draft manufacturing guidance, an FAQ addendum and a final software guidance. In the same year the Ministry of Health widened a clinical-data waiver to cover EU approvals. Together they were read as an overhaul of the IVD rules and a new shortcut for CE-marked tests.
What the instruments say. The CDSCO documents are guidance, and the three main ones say so themselves. The draft import and manufacturing guidances each open with a notice that they are "aimed only for creating public awareness" and are "not meant to be used for legal or professional purposes". The final software guidance says it "reflects current practices under the MDR-2017 and should not be misconstrued as a new regulatory control". They help with preparing a dossier. They do not change what the law requires.
The one actual rule change is G.S.R. 744(E), the Medical Devices (Third Amendment) Rules, 2026, which took effect on publication in the Gazette of 19 August 2026. It amends rule 63 by inserting "or European Union countries" after "or Japan". Rule 63 covers devices that have no predicate in India. Under it, the results of a clinical investigation "may not be required" if the device is approved by the UK, US, Australia, Canada or Japan, now joined by the EU, and has been marketed there for at least two years. Conditions apply.
This does not reach new IVDs. A "new in vitro diagnostic medical device" is one "not approved for manufacture for sale or for import" by the Central Licensing Authority. It is approved under rule 64, not rule 63, and rule 64 has no reference-country proviso. The information rule 64 requires (Part IV of the Fourth Schedule) includes "Clinical Performance Evaluation data carried out in India and in other countries (if any)". G.S.R. 744(E) did not touch rule 64. Rule 64 has its own narrower provisos. Clinical data may be "abbreviated, deferred or omitted" for life-threatening or serious diseases, diseases of special relevance to India, national emergencies, epidemics, or where no diagnostic exists. And Class A new IVDs may not need clinical performance evaluation data.
What to do. First establish whether an equivalent IVD is already approved in India. If one is not, your test is "new", and a CE mark or FDA clearance does not remove the Indian clinical performance evaluation. Budget for it, and for the time it takes. Most startup IVDs are new in this sense. If your device is not an IVD and has no predicate in India, the EU waiver may apply. Check the two-year marketing condition before you rely on it.
4. Mexico: "Mexico recognises ANVISA approvals"
The headline. On 2 September 2026 Mexico's official gazette (the DOF) published an Acuerdo setting up an abbreviated pathway that recognises the evaluations of Brazil's regulator, ANVISA. Brazil is a large, hard market. A Brazil-to-Mexico shortcut sounded like a reason to file in Brazil first.
What the instrument says. Its title is explicit: Lineamientos Generales para la aplicación de la vía regulatoria abreviada para el otorgamiento de los registros sanitarios de medicamentos, recognising ANVISA's requirements, tests and evaluation procedures. It covers medicines. The word dispositivo does not appear anywhere in the text. Its first transitory article says it takes effect 30 business days after publication.
What a device company has instead. Mexico already has an abbreviated route for devices, and it already covers Brazil. The Acuerdo published in July 2025 (signed 15 July 2025) on the vía regulatoria abreviada para insumos para la salud applies to medical devices (article 3, section II). Article 24 says that, for devices, COFEPRIS recognises decisions of the reference authorities of the countries on the IMDRF Management Committee. Under article 36, COFEPRIS checks only that the dossier is complete, "sin hacer un mayor escrutinio de evaluación". Article 38 gives it 30 business days to resolve. According to HSA's IMDRF page (13 March 2026), Brazil is on that Committee, together with Australia, Canada, China, the EU, Japan, Russia, Singapore, South Korea and the US.
What to do. Do not re-sequence your Latin American plan because of the September Acuerdo. If you hold an approval from any IMDRF Management Committee member, the 2025 device route is the one to use. COFEPRIS still classifies the device under its own rules (article 32), and the device must be the same as the one the reference authority approved. Registration in Mexico is held locally, so the holder you choose files on your behalf and owns the registration. Settle that before you file.
5. United Kingdom: "MHRA assesses Phase 1 trials in 14 days"
The headline. The MHRA is moving to a 14-day first assessment for Phase 1 trials. For a founder planning first-in-human work, the UK looked like a faster place to start.
What the instrument says. The 14-day assessment stepwise implementation programme shortens the MHRA's first review in steps: 28 days from 30 March 2026, 21 from 29 June, 18 from 28 September and 14 from 28 December 2026. It is limited to low-risk Phase 1 trials, mainly in healthy volunteers, and places are capped. Its exclusion criteria list a trial that "Involves a medical device, an in vitro diagnostic (IVD), or a companion diagnostic", and also first-in-human trials.
What to do. A device or IVD clinical investigation goes through the MHRA's separate device process, which this programme does not change. A drug–device combination or a companion-diagnostic study is excluded by name, so plan it on standard timelines.
How to read the next one
All five headlines went wrong in one of three ways. Three questions catch them, and each takes a few minutes with the instrument open:
- Does it cover devices? Read the scope clause or the title, not the press release. Medicines regulators and device regulators are often the same agency, and that agency's announcements and guidelines often cover only one of the two. All five here came from agencies that regulate both.
- Is it a route, or an MoU? A route has a form, a fee, a review clock, eligibility rules and a named reference authority. A memorandum of understanding promises cooperation and to "explore" pathways. It is worth watching, but you cannot file under it.
- Is it in force, or draft guidance? A draft, a consultation, a guidance document that says it does not change the rules, and a gazetted amendment are four different things. Only the last one changes what the regulator can require of you. Check which class of device it covers as well. India's waiver is in force, but not for new IVDs.
Two of the five headlines pointed away from a device route that already existed. Which approval shortens which review, and in what order to file, is a question that spans markets. A single market's announcements do not answer it. Our market assessments set out the device routes market by market, with the instrument behind each one.
Sources
- Health Sciences Authority (Singapore): "HSA Extends Partnerships to Speed Access to Health Innovations Across Key Markets in Africa, Malaysia and Saudi Arabia", 17 September 2026. "Regulatory Reliance" (medical devices, last updated 13 March 2026). "International Medical Device Regulators Forum (IMDRF)" (last updated 13 March 2026)
- Saudi Food and Drug Authority: MDS-G30, SFDA Reliance Approach for Medical Device, version 1.0, 9 September 2026 (MDS-G-030-V1/260909)
- Pharmacy and Poisons Board (Kenya): Guidelines on the Reliance and Recognition of GMP Decisions, HPT/ISE/GMP/GUD/102, revision 0, August 2026 (posted 9 October 2026). Guidelines on Reliance Mechanisms for Marketing Authorization of Health Products and Technologies in Kenya, HPT/PER/GUD/091, revision 0, January 2025, sections 4.2, 4.4, 4.5 and the Class A provision
- Ministry of Health and Family Welfare (India): G.S.R. 744(E), Medical Devices (Third Amendment) Rules, 2026, Gazette of India Extraordinary No. 678, 19 August 2026. Medical Devices Rules, 2017 (CDSCO consolidated text): definitions in rule 3, rules 63 and 64, and Fourth Schedule Part IV
- CDSCO: draft guidance for import of IVDs (CDSCO/IVD/GD/DRAFT/IMP/01/2026). Draft guidance for manufacture of IVDs (CDSCO/IVD/GD/DRAFT/MFG/01/2026). Guidance on medical device software (CDSCO/MD/GD/MDSW/01/2026)
- Secretaría de Salud / COFEPRIS (Mexico): Acuerdo on the abbreviated pathway for medicine registrations recognising ANVISA, DOF 2 September 2026. Acuerdo on the abbreviated pathway for health supplies recognising reference regulatory authorities, signed 15 July 2025, Anexo Único articles 3, 24, 32, 33, 36 and 38
- Medicines and Healthcare products Regulatory Agency (UK): "14-day assessment stepwise implementation programme for Phase 1 clinical trials", first published 17 August 2026, updated 30 September 2026, Table 1