Asia-Pacific Roundup: Malaysia’s MDA seeks feedback on changes to medical device exemption processes
Malaysia’s Medical Device Authority (MDA) is holding consultations on planned changes to guidance on export-only and unregistered products.MDA published the first edition of its guidance on export-only medical devices in 2019. The document described the requirements, process, and fee for notifications for export-only products. Last year, when it expanded its medical device exemption order, MDA included products intended solely for export. The draft guidance, now open for consultation, reflects the expanded exemption order.
“The application for an exemption of medical devices for the purpose of export only is mandatory based on the requirements stipulated under the Medical Devices (Exemption) Order 2024,” MDA wrote in the draft. “The applicant who wishes to export the medical device from Malaysia shall apply for an exemption to the Authority prior to the exportation.”
In the draft, MDA describes the process for seeking an exemption, explaining how applicants can send an email or use a Google Form to submit the required information. The agency also used the draft to list the information applicants need to provide in each section of the form, including the supporting documents, such as quality management certificates, that they should attach to their submissions.
The regulator published the draft alongside another document about the import and supply of medical devices under special access exemption applications. MDA’s special access scheme, which is covered by a guidance document published in 2020, provides a regulated framework for sourcing unregistered devices when conventional medical treatments have proved ineffective, are unavailable, or are unsuitable.
Like the export-only process, the special access scheme was affected by the expanded exemption order, and the proposed draft reflects the 2024 legislation. The special access draft describes situations when the mechanism is needed, such as shortages, compassionate-use cases, and emergencies that pose an imminent threat to a patient’s life or long-term well-being.
MDA also set out the process for applying for special access, how to label devices supplied under the scheme, the validity of the exemption, and the applicant's responsibilities. The responsibilities include “taking immediate corrective actions” in response to adverse incidents and ensuring that “proper installation, testing, commissioning, and acceptance are completed by the manufacturer.”
Both drafts are open for comment until 7 May.
Export Draft, Special Draft
PMDA posts considerations for non-clinical studies of diagnostic radiopharmaceuticals
Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has explained aspects of its guideline on running non-clinical studies of diagnostic radiopharmaceuticals.
PMDA said that, while the general guideline summarizes non-clinical study items, discussions often arise about the details and timing of steps in developing diagnostic radiopharmaceuticals. The agency created the early consideration document to explain the guidance and provide its current perspective, which is shaped by newly issued International Council for Harmonisation guidelines.
The early consideration document covers three main points, starting with data on the pharmacological action. PMDA said the requirement to run “safety pharmacology core battery studies” before testing a molecule in humans may not be applicable if the administered dose is in the microdose study range.
PMDA said omission of the studies may be considered “if it can be appropriately demonstrated that there is no impact on the functions of vital organs. " The agency is advising companies to consult with its teams on a case-by-case basis to determine the need for safety pharmacology studies. The assessments will consider factors such as experience in other countries and information on related compounds.
The second point covers data on absorption, distribution, metabolism, and excretion. PMDA said information on drug-drug interactions is valuable for ensuring the appropriate use of diagnostic radiopharmaceuticals. The agency recommends developers assess potential drug interactions stepwise, considering the stage of development.
If a drug is given as a single dose and rapidly eliminated from the body, PMDA said companies may not need to “conduct in vitro studies to assess its potential to induce drug-metabolizing enzymes.” The agency also noted that the risk of pharmacokinetic drug-drug interactions is generally considered lower for biologics than small molecules and that difference should inform the testing strategy.
PMDA’s third point addresses data on acute, subacute, chronic toxicity, teratogenicity, and other toxicity studies. The section covers repeated-dose toxicity, explaining when a shorter-duration repeated-dose toxicity study or an extended single-dose toxicity study may be acceptable, and the safety evaluation of radiolytic products.
PMDA Considerations
NMPA shares materials to help companies access the mainland China medicine market
The National Medical Products Administration (NMPA) has published application materials and technical requirements to help oral Chinese medicine companies in Hong Kong and Macao access the mainland market.
NMPA seeks to streamline Chinese medicine approval processes for some manufacturers registered in Hong Kong and Macao. In January, the agency shared details of its plans to open a new pathway for companies registered with the Chinese Medicine Council of Hong Kong for more than 15 years. To use the streamlined pathway, companies must comply with good manufacturing practices.
The Hong Kong Department of Health shared an update on the project after NMPA published application materials and technical requirements last week. Officials in Hong Kong vowed to “spare no effort” to help Hong Kong-registered proprietary Chinese medicines (pCms) access the mainland market.
“This new measure has greatly streamlined the requirements and shortened the time for approval, thereby opening up a more convenient channel for the Hong Kong CM industry to tap into the vast Mainland market, further facilitating Hong Kong pCm manufacturers' market expansion on the Mainland and promoting the development of the CM industry,” Ronald Lam, Hong Kong’s director of health, said.
Press Release
CDSCO updates online portals to guide companies completing forms
India’s Central Drugs Standard Control Organization (CDSCO) has incorporated tooltips into its SUGAM and medical device online portals to help applicants complete legal forms.
The update adds information icons or help text next to the fields of the forms hosted on the portals. Users can hover their mouse cursor over the icons or text to view tooltips, which are popups that provide more information or context about a field. CDSCO sees the text boxes to guide the specific requirements for each drug and medical device form field.
“By offering clear instructions on expected inputs, this feature aims to minimize errors and facilitate the quality of submissions,” CDSCO said. “We encourage stakeholders to utilize this functionality while filling out the application on both portals.”
CDSCO Notice
Other News:
The Indian Pharmacopoeia Commission (IPC) has proposed changing the titles of certain monographs. The changes would affect the 2026 edition of the Indian Pharmacopoeia, which the IPC aims to publish in December and bring into force in July 2026. The IPC encourages early adoption of the new titles but will allow the old and new titles to be used interchangeably until July 2026. IPC Notice
China’s NMPA has published quality management regulations for the online sale of medical devices. The document is intended to standardize quality management and ensure safety and effectiveness. The text is set to take effect on 1 October. NMPA Notice (Chinese)
Australia’s Therapeutic Goods Administration (TGA) has shared an update on the transition to sole ingredient names. TGA Notice
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