REGULATORY UPDATE | Guidance Document Second Edition “Licensing for Enterprises” (MDA/GD/0027)

The Medical Device Authority (MDA) has announced the release of the Guidance Document Second Edition titled "Licensing for Enterprises" (MDA/GD/0027), available from September 23, 2022. This guidance document is designed to assist public health services and industries in complying with the Medical Devices Act (UU 737) and its related requirements.

According to Section 15 of the Medical Devices Law of 2012, an establishment permit is mandatory (UU 737). Before importing, exporting, or marketing medical devices, all companies described in Section 2 of the 737 Act must obtain a license. This guidance document aims to provide clarity on the licensing requirements for Malaysian businesses involved in medical devices, ensuring compliance with the Medical Device Act and relevant regulations.

Several key points are highlighted in the Guidance Document Second Edition:

1. Compliance with Regulations: Companies must adhere to the Medical Device Regulations (Duties and Obligations of Establishment) 2019, which govern the post-marketing processes for medical devices. When submitting an application, companies are required to provide information on their establishment, the person in charge, contact points, and details of their quality management system (QMS). Additionally, they must include the approval of the establishment permit application.
2. Termination of Authorized Representative (AR):
   • Without AR Replacement: If an authorized representative wishes to revoke their authorization for specific medical devices, they must send an official letter to the manufacturer. This letter should be signed by the Responsible Person and printed on the authorized representative's letterhead, along with a termination letter from the manufacturer.
   • With AR Replacement: When replacing an AR, the following steps must be taken:
     • Current AR: The current AR must send the official letter notifying the manufacturer of the termination.
     • New AR: The new AR, which is already licensed, must submit an official letter indicating the new authorization, accompanied by the Letter of Authorization (LOA). A new AR without an establishment permit will need to apply for one according to Clause 7.
3. Revisions on Cost Activities: License fees vary based on the category of the license. Companies can submit multiple license applications. According to Schedule Fifth of the MDR 2012, the costs are as follows:
   • Application Fee: RM 250.00
   • Costs for Different Types of Licenses:
     • Manufacturer: RM 4,000.00
     • Authorized Representative (AR): RM 4,000.00
     • Importer: RM 2,000.00
     • Distributor: RM 2,000.00
   • Renewal Fees for Various Types of Licenses:
     • Manufacturer: RM 4,000.00
     • Authorized Representative (AR): RM 4,000.00
     • Importer: RM 2,000.00
     • Distributor: RM 2,000.00

It is important to note that all companies with an active incorporation permit must apply for an additional permit specific to their activities at least 90 days before their current permit expires.

For inquiries regarding the registration of medical devices.

Otoritas Alat Kesehatan (MDA) telah mengumumkan rilis Dokumen Panduan Edisi Kedua yang berjudul “Lisensi untuk Perusahaan” (MDA/GD/0027), yang mulai tersedia pada 23 September 2022. Dokumen panduan ini didesain untuk membantu layanan kesehatan publik dan industri dalam mematuhi Undang-Undang Alat Kesehatan (UU 737) serta persyaratan terkait lainnya.