The article provides an overview of the regulatory requirements in the sphere of establishment licensing and highlights the key points to be taken into consideration.
The Malaysian Medical Device Authority (MDA), a country’s regulatory agency in the sphere of healthcare products, has published an updated guidance document dedicated to the establishment of licenses required for interested entities to be allowed to conduct operations with medical devices. The document is intended to provide additional clarifications regarding the existing regulatory requirements, as well as recommendations to be considered to ensure compliance thereto. At the same time, provisions of the guidance are non-binding, nor are intended to introduce new rules or impose new obligations. The authority also reserves the right to make changes to the guidance, should such changes be reasonably necessary to reflect corresponding amendments to the underlying legislation.
The aspects related to establishment licensing are regulated under the Medical Device Act 2012 (Act 737). In particular, the said act defines an establishment subject to licensing and also outlines the requirements they should meet to be allowed to import, export medical devices, or make them available on the market. The scope of the document covers the aspects related to the procedures associated with obtaining an establishment license, the responsibilities and obligations of interested entities, changes to the information related to interested entities, as well as licenses covering several types of activities or their renewal.
Terms and Definitions
To assist the industry with interpreting the applicable provisions of the underlying legislation, the authority provides definitions of the most important terms and concepts used in the context of establishment licensing. The definitions provided in the guidance include, inter alia, the following ones:
- Distributor – any natural or legal person in the supply chain who, on his behalf, places a medical device on the market and furthers the availability of the medical device to the end user including persons in the supply chain involved in activities such as storage and transport on behalf of the authorized representative, importer or distributor.
- Distribution – the activities of pre(release), placement (delivery), and postdelivery of medical devices conducted by the establishment.
- Establishment – according to the guidance, it stands for
- (a) a person who is either a manufacturer, importer, or distributor who is responsible for placing any medical device in the market but does not include a retailer; and
- (b) an authorized representative appointed by a manufacturer having a principal place of business outside Malaysia.
and such a person and authorized representative being (a) a person domiciled or resident in Malaysia, or (b) a firm or company constituted under the laws of Malaysia and carrying on business or practice principally in Malaysia.
- Good Distribution Practice for Medical Devices (GDPMD) – the regulatory requirements for authorized representatives, importers, and distributors of medical devices on a quality management system to be established, implemented, and maintained by the establishment in carrying out activities throughout the medical device supply chain.
- Tendering Agent – a person or firm that participates in the tendering process to supply medical device(s) and does not carry out activities as a manufacturer, AR, distributor, or importer of the medical device(s); and is authorized by any establishment only to participate in the tendering process in healthcare institutions.
Apart from the ones described herein above, the guidance also provides definitions of such terms and concepts as “multiple roles”, “licensee”, “place in the market”, “retailer”, and “manufacturer”.
The document further describes the general requirements as set forth by the applicable legislation concerning establishment licensing. According to the guidance, as the very first step, an interested person should obtain a letter of authorization. As explained by the MDA, such a letter could be obtained from the manufacturer or its authorized representative (AR). It is also stated that the importer and distributor conducting operations with the same medical device could be authorized by the initial medical device manufacturer by the device of the same letter of authorization.
To be eligible for an establishment license, an interested entity should be established in Malaysia. Such an entity should also appoint a person to be responsible for the entity in terms of regulatory requirements set forth under Act 737. It could be a person from top management residing in Malaysia, the details of such a person should be communicated to the authority in the course of the application. Apart from this, it is also necessary to appoint a contact person – the one who will represent the entity in all interactions with the regulating authority.
According to the guidance, an interested entity shall also obtain a quality management system (QMS) certification from an authorized Conformity Assessment Body (CAB).
In terms of post-market responsibilities, such an entity shall:
- Comply with Medical Devices (Duties and Obligations of Establishments) Regulations 2019 that stipulates the post-marketing requirements of medical devices; and
- Be responsible for all medical devices that the establishment placed on the market; and
- Carry out responsibilities to monitor and continuously ensure the safety and performance of the medical devices in the market throughout the supply chain.
The authority additionally emphasizes that an authorized representative remains responsible for the products it has placed on the market even upon expiration/termination of its authorization. In case the activity of an authorized representative has been transferred to another entity, such an entity should take over the responsibility for the products supplied by the initial AR. The same approach applies to medical device manufacturers – should a local manufacturer decide to cease its activities, it should still be responsible for the devices supplied in terms of post-market obligations within the projected useful life of such products.
In summary, the present guidance provides an overview of the regulatory requirements entities intended to operate with medical devices are subject to, as well as the definitions of the most important terms and concepts used in this respect. Apart from this, the document also outlines the key points to be taken into consideration for establishment licenses.