The new article describes in detail the aspects related to establishment licenses, as well as the requirements related to the licenses for retailers and tendering agents.
The Malaysian Medical Devices Authority (MDA), a country’s regulatory agency in the sphere of medical devices, has published a guidance document dedicated to the regulatory requirements for the establishment of licenses required for the entities conducting operations with medical devices allowed for marketing and use in the country. The guidance describes in detail the regulatory requirements set forth under the existing framework and also provides additional recommendations to be considered to ensure compliance thereto. At the same time, provisions of the guidance are non-binding, and in case of any discrepancies with the respective provisions of the underlying regulations, the latter should prevail.
Retailers and Tendering Agents
According to the guidance, in case retailers or tendering agents are involved in such activities as manufacturing, importation, exploration, and distribution of medical devices, they should obtain the appropriate establishment licenses required for the type of activities they undertake. Apart from this, they will be responsible for ensuring compliance with the respective regulatory requirements set forth under the applicable legislation.
Concerning tendering agents, the authority mentions that they should be appointed by the virtue of a written agreement or a Letter of Appointment issued by a responsible entity.
License Types
The document further describes in detail the existing types of establishment licenses and highlights the key points associated thereto. Under the general rule, the licensing regime introduced in the country is based on activities the entity is subject to licensing undertakings. However, the authority acknowledges that in certain cases, an entity may conduct several types of activities simultaneously, and this will impact its regulatory status.
To the applicable regulatory requirements, a separate license is required for each type of activity. The authority provides an example of a situation when the same entity acts as a medical device manufacturer and a distributor – in such a case, both licenses will be required.
The existing legislation provides four types of establishment licenses, namely:
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License for the manufacturer – a license granted to an establishment that manufactures a medical device; a manufacturer who distributes a medical device from other manufacturers are required to apply for a separate establishment license as a distributor.
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License for authorized representative (AR) – a license granted to an establishment that represents a foreign medical device manufacturer relating to any regulatory obligations under Act 737. In this respect, the authority additionally mentions that registration of medical devices may be done by more than one authorized representative.
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License for importer – a license granted to an establishment that performs importation of medical devices; an importer shall only import registered medical devices and is authorized by the authorized representative of that medical device. It is also stated that a person who imports a medical device for transit only does not require an establishment license.
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License for distributor – a license granted to an establishment that performs the distribution of medical devices. According to the guidance, a distributor shall only distribute the registered medical device and is authorized by the authorized representative/manufacturer of that medical device.
Licensing Process: Key Points
Apart from the information about the types of establishment licenses existing under the current regulatory framework, the document also provides an overview of the process to be followed when applying for a license. To assist interested parties in interpreting and following the respective regulatory requirements, the authority provides a flowchart illustrating the whole process.
According to the aforementioned flowchart, the process starts with the determination of whether the activities to be undertaken are related to medical devices. At the next step, the type of establishment should be determined, as this will impact the scope of applicable standards. For instance, medical device manufacturers should comply with ISO 13485:2017, while authorized representatives, distributors, and importers would have to demonstrate compliance with the Good Distribution Practices for medical devices in terms of the Quality Management System (QMS) employed. Compliance with the respective standards and requirements should be confirmed by a conformity assessment body (CAB).
The authority also describes in detail the requirements to be followed for the interested entity to be eligible for applying for an establishment license. In particular, it is explained that the interested entity should appoint a conformity assessment body to conduct the assessment of the Quality Management System. Upon completion of the assessment, the conformity assessment body will issue a report describing its findings, as well as the appropriate certificate.
The application for an establishment license, irrespective of its type, should be submitted in electronic form online via the special submission system – MeDC@St 2.0+. The application should be accompanied by all the necessary documentation the authority may reasonably need to assess compliance with the respective regulatory requirements.
In summary, the present MDA guidance describes in detail the types of establishment licenses prescribed under the applicable legislation. According to the document, the type of establishment license an entity will need should be determined based on the activities it is going to undertake. As it is stated in the document, each type of activity requires a separate license to be obtained. The document also provides an overview of the application process, including the particular steps an interested party should take before submitting an application to the authority for further review.
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