Asia-Pacific Roundup: Malaysia’s MDA shares guidance on conformity assessment of devices cleared overseas

Malaysia’s Medical Device Authority (MDA) has published a pair of guidance documents to explain the conformity assessment process for medical devices that have obtained approval from recognized foreign authorities.

MDA established a process for relying on conformity assessments performed overseas to support market access in Malaysia in 2014. On 11 March, the agency revealed a new process. MDA designed the two new guidance documents to be read alongside the 11 March text. With the publication of the guidance, MDA canceled the 2014 document and established a new process for conformity assessment reliance.

One of the guidance documents provides a guide to the verification process, MDA’s term for approvals that rely on foreign approvals, for conformity assessment bodies. MDA outlined how verification can simplify approvals, reduce costs, and speed up the registration of medical devices in Malaysia.

“Since most medical devices have already undergone conformity assessments and been approved for marketing in certain countries, the MDA has established a policy to simplify the conformity assessment process for devices approved in MDA-recognised countries,” MDA said. “This recognition eliminates the need to repeat the conformity assessment process and approval for a medical device.”

Manufacturers need to have obtained full approval from at least one recognized competent authority and marketed the device for at least one year to seek initial authorization via the verification pathway. Other rules state the device must have the same design and intended purpose as the foreign product and not have been linked to any deaths, serious deteriorations in health or recalls in the past year.

Different rules apply to recertification assessments, which cover devices that are already registered with MDA. The timeline for both processes is the same, though, with MDA estimating a 1.5-month duration for the two procedures. Certificates of conformity are valid for up to five years.

The second guidance document applies to medical device establishments and covers some of the same information as the text aimed at conformity assessment bodies. A key difference is the guidance for device establishments explains the process of applying for verification through the Medical Device Centralised Online System, a portal also known as MeDC@St.

MDA lists the information that applicants need to include in initial and re-registration applications, which differ for Class A and Class B, C and D devices, and explains how to submit responses in MeDC@St. A conformity assessment body may refuse to register a device if the manufacturer fails to share mandatory information within 30 working days or provide other responses within 90 working days.

MDA Notice (Malay)

Access Consortium updates strategic plan, teeing up work-sharing in Australia, Singapore

The Access Consortium has published its strategic plan for 2025 to 2028, providing a roadmap for how regulatory agencies in Australia, Singapore, and other countries will collaborate in the coming years.

Through Access, regulatory agencies in Australia and Singapore work with their counterparts in Canada, Switzerland, and the United Kingdom. The consortium has expanded since its creation, both in terms of the breadth of activities that its members collaborate on and because the UK joined after Brexit. The latest strategic plan features two new objectives and changes to two existing objectives.

The new goals are supporting regulatory innovation and enhancing engagement. To support regulatory innovation, the consortium plans to strengthen and use “regulatory scientific capability and capacity within Access for emerging technologies and innovative products” and leverage “joint pipeline meetings to support innovative products and novel therapeutic approaches.”

Access’ plans to enhance engagement include developing and implementing an effective communication strategy with stakeholders, creating and monitoring a stronger online presence, and establishing regular reporting to stakeholders on its work-sharing initiatives, major achievements, and decisions. The group shared the strategic plan on its newly launched webpage.

The other two objectives—strengthening work-sharing and expanding the lifecycle approach—were part of the 2021 to 2024 strategic plan. Access has updated its plan to achieve the goals, though, with its work-sharing focus shifting away from increasing the number and variety of applications toward improving the predictability of the procedures.

For the lifecycle objective, Access now wants to explore “collaboration and information sharing on clinical trials and upstream scientific advice and review opportunities for joint working on assessment.” Having established collaboration and information sharing on risk management, pharmacovigilance and post-market safety under the old plan, Access wants to strengthen those mechanisms through 2028.

Access has established new indicators of success associated with the plan. The consortium wants to see an increase in the number of products and risk management plans it assesses, decreases in the median submission gap and approval time, and reduced duplication of effort for both regulators and industry.

Strategic Plan

Japan’s PMDA translates checklist for completing quality sections of new drug submissions

Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has published an English-language version of a checklist intended to help companies complete the quality sections of new drug submissions.

PMDA’s quality group compiled the checklist based on issues that frequently come up as the Office of New Drug assesses applications. The checklist is designed to serve as a reference to help applicants voluntarily verify the contents of their submissions. PMDA said it created the checklist to “facilitate more efficient submission and assessment processes for approval applications.”

The checklist, which was published in Japanese in January, poses questions such as, “Is the description of the manufacturing site's licensing/accredited classification and code appropriate?” PMDA has included an explanation for each question and a box for applicants to tick off each item.

Applicants do not necessarily need to fulfill all the items on the checklist, PMDA said. Rather, the agency is encouraging companies to refer to the document “as appropriate, considering the characteristics and circumstances of each product.”

PMDA Checklist

MDA sets January deadline to use online portal for seeking Malaysian import permits

MDA has published the timeline for transitioning to the mandatory use of an online system for seeking permits to import medical devices into Malaysia.

The agency began preparing for the transition in 2023. Since then, Malaysia has included medical device tariff codes in the Customs (Prohibition of Import) Order 2023, developed an ePermit system and written guidelines and a user manual to help importers understand the application process.

The system is set to go live on 14 April, marking the start of the transition period. MDA plans to end the transition period early next year. Starting 2 January, the use of the online import permit system will be mandatory.

MDA is asking applicants to seek permits at least seven days before shipping medical devices. The agency said import permits will be processed within three working days from the application date. In urgent situations, such as overnight shipments by road from Singapore or Thailand or imports of temperature-sensitive goods, MDA may process requests within 24 hours of the confirmation of payment.

MDA Notice

Other news

Australia’s Therapeutic Goods Administration (TGA) is asking users of its website to participate in an online study. The study is intended to show TGA how easy or hard it is to find information on the current website. TGA will use the results to inform changes to the website. A second study will assess if the changes have made the site easier to navigate. TGA Notice

Asia-Pacific Roundup: Malaysia’s MDA shares guidance on conformity assessment of devices cleared overseas

Related topics

Recommended content

Welcome to the new RAPS Digital Experience