Medical Device Registration in Malaysia

Medical Device Registration in Malaysia Andaman Medical 2018-05-31T10:24:47+08:00

Market Opportunity in Malaysia

The medical device industry in Malaysia is a rapidly growing industry with extensive opportunities for investors, local manufacturers, importers and exporters

The medical device industry in Malaysia consists of three sectors: 1 – manufacturers, 2 – suppliers of raw materials and services to the medical device manufacturing companies and 3 – importers and exporters of medical devices. This industry has been included under the Healthcare NKEA, whereby eight (8) Entry Point Projects (EPPs) for the medical device sub-sector were announced by the Government. These will create RM17.12 billion in revenue and RM11.4 billion in GNI, and is likely to generate 86,000 jobs by 2020.

In addition, a number of incentives have been made available for investment, for example, incentives for operational headquarters (OHQ), regional distribution centres (RDC), Research & Development (R&D), International Procurement Centres (IPC) and many others. With the implementation of the Medical Device Act 737, commencing in 2013, all medical devices manufactured, imported or sold in Malaysia are required to be registered.

Under the regulations, those producing or importing these items must be registered with the Medical Device Authority (MDA), a body under the Ministry of Health Malaysia responsible in supervising the medical device industry. Not only do the medical device regulations ensure that Malaysia is recognised as a reliable producer of medical devices on the global stage, they also assist in attracting foreign investment with improved market confidence and support joint ventures between local and foreign companies.

Andaman Medical can act as your in-country representative

If the medical device manufacturer is not present in Malaysia, it is required to authorize an authorized representative to act on its behalf to conduct the conformity assessment as laid out in the Medical Device Regulations. Andaman Medical can be the appointed as the local authorized representative for those companies that do not have an establishment that is operating in Malaysia. As a local authorized representative, Andaman Medical can liaise with both the MDA and the company to ensure that an appropriate conformity assessment is completed.

In addition, Andaman Medical has the in-house expertise to support a company in preparing submission files that comply with specific local regulations. We will provide a responsive service to address the submission and compliance requirements for the medical device industry. Andaman Medical can also provide support and guidance throughout the application process for a Malaysian establishment license right up until approval is granted!

Services

Local Representation

As a local authorized representative (LAR), Andaman Medical can hold a license on behalf of foreign manufacturers looking to market medical devices in Malaysia. According to the Medical Device Regulations 2012, if the medical device manufacturer is not present in Malaysia, it is required to authorize a local representative to act on its behalf. An independent local authorized representative (LAR) like Andaman Medical can help to prevent any conflict of interest between the manufacturer and the importer and distributor, and can reduce the time spent managing regulatory matters.

Medical Device Registration

The Common Submission Dossier Template (CSDT) is the format required for the submission of required information to the MDA as part of the product registration application process in Malaysia. With more than 10 years’ experience in the medical field, our in-house experts are able to compile your technical documents and prepare customized dossiers such as the CSDT for medical device registration in Malaysia. We have a proven track record of completing dossiers efficiently with minimal questions and feedback received from MDA.

Established License

No idea on how to apply for an establishment license as a manufacturer, importer, distributor or authorized representative? You need not worry. We have a team of consultants who are well-versed in the requirements and the Medcast system to assist you with your applications. The step-by-step guidance and consistent follow-up will help to expedite the application and approval process.

Quality Management System

As an importer, distributor or authorized representative of medical devices in Malaysia, the regulations require compliance with the Good Distribution Practices for Medical Devices (GDPMD). Andaman Medical are able to provide support to implement adequate and customized processes to comply with the GDPMD requirements. For local manufacturers looking to implement QMS for their business objectives, we also offer consultancy for ISO 13485:2016 certification. We are experienced in liaising with the conformity assessment body (CAB) for ISO 13485 implementation and certification

"Since appointing Andaman Medical as our partner, their consultants have been great in assisting us in understanding the MDA's regulations. Their service have always been prompt and professional. It demonstrates the competence of Andaman Medical. We look forward to a great long-lasting relationship with Andaman Medical."

- Jonathan Soh
Hitachi Medical

"We have been cooperating with Andaman Medical for more than a year. They are very professional, extremely organized, and prompt in responding to all our questions and queries. We appreciate the expertise of the staff and their customer-oriented attitude, and we are grateful for their regulatory support when entering new markets."

- Mojca Valjavec
Biocartis N.V.

"We are satisfied with the service we receive from Andaman Medical, their professional regulatory advice, and the monthly follow-up support. The support from Andaman Medical is always quick and clear and we are tremendously grateful for the service"

- Tetsuo Murakami
Japanese Organization for Medical Device Development, Inc.

"Good regulatory consultant to work with. The staff are knowledgable and they handle all enquiries promptly and efficiently. The client requirements/queries are rightly analyzed, and consultants provide valuable feedback. Keep up the good work!"

- Oculus Private Ltd.
Oculus Private Ltd.

"We appreciate working with Andaman Medical. We are very satisfied with your reactivity and we find you very helpful. Andaman Medical has a high level of competence and the consultants are attentive to our needs. We strongly recommend Andaman Medical and if we expand our business, we will use your services again in the Asia-Pacific region"

- Sylvain Fogola
Olea Medical