The article provides an overview of the current regulatory framework for the re-registration of medical devices in Malaysia and describes in detail the most important aspects to be considered when submitting a respective application.
The Medical Device Authority (MDA), a Malaysian regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to the re-registration of medical devices that are already placed on the market. The document is intended to provide additional clarifications regarding the applicable regulatory requirements, as well as recommendations to be considered by medical device manufacturers and other parties involved to ensure compliance thereto. However, provisions of the guidance are non-binding, and are not intended to introduce new rules or requirements; the document could be subject to changes, should such changes be reasonably necessary to reflect the respective changes to the underlying legislation. The authority also reserves the right to request additional information and documents that it deems necessary to complete the review of the application for re-registration.
Under the general rule, any medical devices intended to be marketed and used in Malaysia should be duly registered before being made available to healthcare professionals and patients. The said registration should be performed under the requirements set forth by the Medical Device Act 2012 and Medical Device Regulations 2012. For this purpose, an entity interested in placing its products on the Malaysian market should submit the appropriate application via an online system – “Medical Device Centralized Online Application System”. The initial registration term is 5 years, so to be allowed to supply its products upon expiration of this term, a party responsible for a medical device should duly apply for re-registration.
The scope of the guidance covers any medical devices intended to be marketed and used in Malaysia. The document clarifies the process to be followed before the expiration of the registration.
Re-registration Process in Brief
According to the guidance, the medical device re-registration process is comprised of the following stages:
- Stage 1: Application for conformity assessment conducted by Conformity Assessment Body (CAB). This stage applies to all medical devices, except for the low-risk ones (Class A). The scope of this stage covers the conformity assessment of the quality management system (QMS), post-market surveillance system, technical documentation, and declaration of conformity (DoC). At this stage, the assessment body would also check the documentation related to changes.
- Application for re-registration of medical devices via the online registration system. The particular flow to be followed will depend on whether there were any changes to a medical device during the initial registration. The authority additionally emphasizes that the changes that haven’t been approved by the authority cannot be included in the scope of re-registration.
Re-registration Requirements and Process in Detail
The document further describes in detail specific aspects to be considered by medical device manufacturers applying for re-registration of their products. To describe the process understandably, the document provides a flowchart highlighting the key points and steps to be followed. According to the said flowchart, when applying for a medical device re-registration, the registration holder would have to complete, inter alia, the following steps:
- Apply for conformity assessment application to CAB [conformity assessment body];
- Apply and submit for re-registration of registered medical device application;
- Pay for an application fee;
- Pass the assessment by MDA and get approval;
- Pay for registration fee;
- Obtain a re-registration certificate to be issued by MDA.
The document also provides the estimated timeline for the aforementioned regulatory actions. In particular, the authority states that in the case of low-risk Class A medical devices, the review process should take up to 30 business days, while in the case of the products with higher risk (Classes B, C, and D) the process will take up to 60 business days.
The authority further describes all the steps in detail to emphasize the most important aspects to be considered in this respect. These aspects include, inter alia, the following ones:
- Determination of the regulatory nature of the product in question-based on the applicable legislation (in particular, a definition of a medical device provided in the Act).
- Classification of a medical device by the applicable risk-based classification rules.
- Applying for conformity assessment by a respective conformity assessment body, which will evaluate the evidence and issue a certificate.
- Taking into consideration the intended use of the device – it should remain the same for the initially registered device.
- Medical device grouping is to be performed following the applicable regulatory requirements set forth by the Medical Device Regulations 2012. The authority also mentions that the list of configurations should also remain the same.
- Submission of a validation report.
- Submission of technical documentation, including supporting documents and labeling.
- An endorsement letter should be issued by the National Pharmaceutical Regulatory Agency (NPRA) in case of combination products.
- Providing information about the medical device manufacturer, as well as about the quality management system it employs (the respective certificates should be provided).
- Submitting information about the post-market surveillance, including the list of incidents and adverse events related to the device occurred in all jurisdictions in which the device is placed on the market.
- Submitting a Declaration of Conformity to be prepared under the template provided in the Medical Device Regulations.
Apart from the matters highlighted hereinabove, the document also provides additional details regarding the way the re-registration fee should be paid, including the calculation of fees and details to be used to complete the payment.
In summary, the present document provides additional clarifications regarding the applicable regulatory requirements in the sphere of medical device re-registration. The guidance outlines the key aspects to be considered by medical device manufacturers in terms of the procedure itself, and also the scope of information and documentation the authority expects to receive together with the application for re-registration.
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