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

MDA has announced the availability of the Guidance Document Second Edition "License for Enterprises" (MDA/GD/0027), which will be available on September 23, 2022. The Medical Device Authority (MDA) created this guidance document to assist public health services and industry in their efforts to comply with the law and the requirements of the Medical Devices Act (UU 737).

Section 15 of the Medical Devices Law of 2012 stipulates the need for an establishment permit (UU 737). Before they can import, export or place medical devices on the market, all companies as described in Section 2 of the 737 Act must obtain a license. This Guidance Document has been created to provide advice on the licensing requirements for Malaysian businesses working with medical devices to comply with the Medical Device Act and regulations.

There are several main points of the Guide Document Second Edition. Companies must follow the Medical Device Regulations (Duties and Obligations of Establishment) 2019 which regulates the post-marketing process of medical devices, in making an application, the company must provide establishment information, person in charge of establishment, contact point, quality management system (QMS), approval of application for establishment permit and Application Submission.

Termination of authorized representative (AR) with AR replacement and without AR replacement

- Without AR replacement::

An official letter notifying the manufacturer of the discontinuation, signed by the Responsible Person and printed on the letterhead of the authorized representative company, must be sent by AR wishing to revoke authorization from the manufacturer for certain medical devices. This letter, which must be signed by senior management on company letterhead from the medical device manufacturer, must be accompanied by a termination letter from the manufacturer.

- With AR replacement:

: There are several steps that must be taken when AR is to be replaced with a new AR.

• AR saat ini: An official letter notifying the manufacturer of the discontinuation, signed by the Responsible Person and printed on the letterhead of the authorized representative company, must be sent by AR wishing to revoke authorization from the manufacturer for certain medical devices. This letter, which must be signed by senior management on company letterhead from the medical device manufacturer, must be accompanied by a termination letter from the manufacturer.

• AR Baru: New AR: New AR already licensed must submit official letter informing new authorization, together with LOA. A new AR without an establishment permit will apply to applications for an establishment permit according to Clause 7.

Revision on cost activities in guidance document 2 License fees vary depending on the category. A company can submit many license applications. With respect to Schedule Fifth, MDR 2012, the costs are as follows.
– - Application Fee: RM 250.00
– - Cost of different types of licenses:

• Manufacturer 4,000.00
• Authorised Representative (AR) 4,000.00
• Importer 2,000.00
• Distributor 2,000.00

– - Application Fee: RM 250.00
– Renewal Fees of various types of licenses:

• Manufacturer 4,000.00
• Authorised Representative (AR) 4,000.00
• Importer 2,000.00
• Distributor 2,000.00

At least 90 days before an existing incorporation permit expires, all companies with an active incorporation permit must apply for an additional permit specific to their activities.

Contact us if you want to inquire about registration of medical devices. Contact Us