The new article highlights the aspects related to different changes to establishment license including, inter alia, changing or adding type of a license, making changes to the name of the entity or the address where the premises are located.
The Medical Devices Authority (MDA), a Malaysian regulating authority in the sphere of healthcare products, has published a guidance document dedicated to establishment licenses to be obtained by the entities interested in conducting operations with medical devices allowed to be marketed and used in the country. The document is intended to provide additional clarifications regarding the applicable regulatory requirements, as well as recommendations to be followed by medical device manufacturers and other parties involved in order to ensure compliance thereto. At the same time, provisions of the guidance are non-binding in their nature, nor are intended to introduce new rules or impose new obligations, other than the ones set forth under the existing regulatory framework. The authority also reserves the right to make changes to the guidance and recommendations provided therein, should such changes be reasonably necessary to reflect corresponding changes to the underlying regulations.
The scope of the guidance covers, inter alia, the aspects related to amendments to the establishment licenses issued by the authority. According to the guidance, should a license holder reasonably need a license to be amended, it should submit the appropriate request to the authority by the virtue of an official letter. As further explained by the MDA, there are six types of amendments to establishment licenses. The document describes each of them in detail and highlights the key points to be considered with respect to each of them.
Change or Add Type of License
The first type of changes described in the guidance is a change of a license type or addition of a new one. According to the guidance, a license holder intended to make such changes should submit a new application via the appropriate online submission system (MeDC@St 2.0).
Inclusion of Additional Letter of Authorization (LOA)
Should an entity obtain an additional letter of authorisation from a medical device manufacturer or its authorized representative, such an entity should submit a set of documents outlined in the guidance, namely:
- An official letter signed by a responsible person and issued on a letterhead of the company.
- A letter of authorisation issued by a new medical device manufacturer or authorized representative. The authority also mentions that it should be provided together with a list of medical devices it covers.
- Updated MS ISO/ISO 13485/GDPMD certificate and audit report (if applicable). Once a license holder decides to implement such changes, it should duly inform the respective conformity assessment body (CAB). The latter will conduct an audit and issue an updated certificate.
Change of a Person Responsible
Specific procedures are also to be followed in case of change of a person responsible for regulatory compliance. According to the guidance, a set of documents to be submitted in such case includes the following ones:
- An official letter served on the company’s letterhead and signed by the current responsible person.
- Identification document for a person to be appointed (an ID card for a Malaysian citizen or passport and work permit for other person).
- Forms and documentation related to the designation of a new person responsible for regulatory compliance.
- Letter of appointment (in case a person is not listed in the abovementioned form).
Changes to the establishment license will also be required in case an entity holding the license will change its name. The authority additionally emphasizes that in such a case, the license holder should not only submit a set of documents described herein below, but also notify the respective conformity assessment body accordingly. The list of documents to be submitted with respect to such changes includes:
- An official letter to be issued on the letterhead of the company and signed by the responsible person.
- Form 13, which contains the details about the name change.
- Form 9 (should be submitted only in case the name of an entity is to be changed from “Enterprise” to “Sendirian Berhad”).
Change of Address
Should the address of an entity holding an establishment license be changed, the appropriate submission is to be filed to the authority. Apart from the official letter containing information about the changes, it will be also necessary to provide an updated ISO certificate and audit report; while the conformity assessment body should be notified accordingly. However, ISO-related documentation will be required only in case of changes to the address of the premises).
Change of Contact Person
A license holder may also change a contact person authorized to act on its behalf in all interactions with the authority. A set of documents to be submitted in such cases should include an official letter and a letter of authorisation to be issued by a person responsible for regulatory compliance.
Change or Termination of Authorized Representative (AR)
The document pays special attention to the aspects related to the change or termination of an authorized representative appointed by the license holder. In particular, the document describes two possible scenarios:
- Termination of AR (without replacement of the AR). Should an authorized representative decide to terminate its relationship with a medical device manufacturer, such a representative should submit the appropriate request as an official letter, together with the letter of termination to be issued by the medical device manufacturer.
- Termination of AR (with replacement of the AR). In case the current authorized representative is to be replaced by the new one, a set of documentation to be submitted by the license holder should contain the details on both representatives, namely:
- For the current representative: an official letter of termination issued by the representative, together with a similar letter issued by the medical device manufacturer.
- For the new representative: if it is already licensed, the documents should include an official letter notifying about authorisation, together with the letter of authorisation. At the same time, in cases when a new authorized representative does not hold a valid establishment license, they should apply for such a license in accordance with the respective regulatory requirements.
In summary, the present MDA guidance provides additional clarifications regarding the changes to establishment licenses and the way they could be implemented. The guidance outlines the documents to be submitted by a license holder with respect to each type of changes and also highlights the key points to be considered in this respect.