KUALA LUMPUR, June 10 — Malaysia’s Medical Device Authority (MDA) has declared that cannabis vaporisers are not classified as medical devices, either locally or internationally, amid controversy surrounding Ispire Technology Inc.
The medical device regulator under the Ministry of Health (MOH) also said Ispire Malaysia Sdn Bhd – the local unit of the United States-based vape company that produces cannabis and nicotine vaporiser hardware in Johor – did not apply for MDA registration to manufacture, register, or sell any medical devices.
“Worldwide, cannabis is not a medical device,” MDA chief executive Muralitharan Paramasua told CodeBlue here yesterday at the sidelines of a dinner event by the Association of Private Hospitals Malaysia (APHM).
“In Singapore, Asian countries, the UK, or even the US, cannabis [vaporisers] are not registered as a medical device.”
Ispire Malaysia is registered with the Companies Commission of Malaysia (SSM) as being in the business of manufacturing “medical and dental instruments and supplies”, according to its company profile accessed by CodeBlue on May 27.
The signboard of Ispire Malaysia’s manufacturing facility in Senai, Johor, describes it as an “electronic medical device factory.”
When pointed out that Ispire’s Malaysia factory has ISO 13485:2016 Quality Management System Medical Device certification, Muralitharan said anyone can apply for ISO certification, but MDA licensing is still required to produce medical devices in Malaysia.
The MDA CEO stressed that under the Medical Device Act 2012, companies must obtain an establishment licence from MDA to manufacture, distribute, import, or be the registered owner of a medical device in the country. This regulatory requirement also applies to medical devices manufactured in Malaysia for export purposes.
“They can claim to have a medical device, but as long as they don’t have a licence from MDA, they can’t do anything,” said Muralitharan.
“Whether you’re manufacturing here, remanufacturing, reexporting, or importing for reexporting – all these activities come under MDA. As long as you don’t have the establishment licence from MDA, that means that you cannot sell.”
When asked if MDA would take action against Ispire Malaysia for claiming to manufacture medical devices despite not being registered with MDA, Muralitharan said the vape company’s operations fall outside MDA’s jurisdiction because it isn’t producing medical devices.
“Right now, they don’t have any product. Cannabis is not a medical device,” the MDA CEO told CodeBlue.
“Cannabis comes under drugs,” he added. “I’m not qualified to talk about cannabis.”
CodeBlue previously reported Ispire Technology, a Nasdaq-listed company based in California, as saying in a quarterly report and investor presentation that it is “currently able to manufacture a wide range of cannabis hardware in Malaysia and import into the US”, and that its Johor factory, which commenced production in February 2024, produces “mainly cannabis-related products.”
Ispire’s US website says the company manufactures a “herbal and medical vaporisers line”, touting its Ispire brand of cannabis vaporisers that offer “great flavour, power, better hits.” According to Ispire’s Q1 2025 quarterly report, the vape company currently sells its cannabis vaping hardware in the US, Canada, South Africa, and Germany.
Health Minister Dzulkefly Ahmad told reporters yesterday that he would refer the issue of whether the government permits cannabis device manufacturing to the Cabinet. The MOH previously confirmed that Ispire received an interim nicotine manufacturing licence from the Malaysian Investment Development Authority (MIDA) last month to produce e-cigarettes with liquid or gel containing nicotine.
Perikatan Nasional health committee head Dr Ahmad Yunus Hairi, who is also Kuala Langat MP, has called for a police investigation into Ispire’s manufacturing operations in Johor, saying that cannabis-related products are subject to the Dangerous Drugs Act (DDA) 1952 and that drugs are a national security issue.
In a statement to CodeBlue last Friday, Ispire Malaysia said all of its vaporiser hardware produced locally are shipped empty, “with no nicotine or cannabis substances involved at any stage of the manufacturing process.”
Ispire Malaysia added that the references cited in CodeBlue’s previous articles on Ispire appeared to have been primarily derived from “marketing statements on Ispire’s US website.”
“These statements pertain exclusively to our business-to-business sales operations in jurisdictions where cannabis and its related items are legal under local laws and regulation. These marketing statements do not accurately reflect the operational scope or conduct of Ispire Malaysia, which strictly adheres to Malaysian laws and regulations,” said Ispire Malaysia.
CodeBlue’s previous reports on Ispire, including a June 5 article titled “Ispire Says ‘Currently Able’ To Manufacture ‘Wide Range Of Cannabis Hardware’ In Malaysia”, mainly quote Ispire Technology’s quarterly report ended March 31, 2025, a YouTube video of an Ispire investor presentation in Las Vegas in April, and company press releases.
Ispire Technology’s various quarterly reports, investor presentations, and press releases were filed with the US’ Securities and Exchange Commission (SEC). SEC filings on the American federal regulator’s portal are accessible to the public from anywhere in the world.
