The article describes updated guidance on re-registration and highlights the key aspects to be taken into consideration for the procedure.
The Medical Device Authority (MDA), a Malaysian regulatory agency in the sphere of medical devices, has published a second version of the guidance document on the re-registration of medical devices. The document provides an overview of the applicable regulatory framework, outlines the most important aspects to be considered, and also provides recommendations to be followed to ensure compliance with the existing regulatory requirements. 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 request additional information or documents, or impose additional conditions, should it be reasonably necessary to ensure the safety and effectiveness of medical devices placed on the market, as well as public health protection. Furthermore, the authority may make changes to the recommendations provided in the guidance to reflect corresponding changes to the underlying legislation.
Regulatory Background
Under the general rule, as set forth by Section 5(1) of the Medical Device Act 2012 (Act 737), any medical devices intended to be marketed and used in Malaysia should be subject to registration before being imported or made available in the country. The said registration should be carried out following the requirements set forth by the Medical Device Regulations (MDR) 2012. All the registration applications should be submitted via an online system. Under the applicable legislation, the registration of a medical device will remain valid for 5 years, so the registration holder would have to apply for re-registration to maintain the permission to operate with the device in question.
The present guidance is intended to provide additional clarifications regarding the regulatory requirements set forth by the existing Malaysian legislation on medical devices, including Act 737 and the MDR 2012. The scope of the guidance covers any medical devices subject to registration to be allowed for marketing and use.
Re-Registration Stages
As further explained by the MDA, the entire process of re-registration includes two stages, namely:
Stage 1: Application for conformity assessment conducted by Conformity Assessment Body (CAB).
According to the applicable legislation, Class B, C, and D medical devices should be subject to a conformity assessment procedure. The scope of assessment should cover the following aspects:
- Quality management system (QMS);
- Post-market surveillance system;
- Technical documentation; and
- Declaration of conformity (DoC).
The authority also mentions that in the course of such an assessment, the conformity assessment body will also review the change notifications related to the product as submitted by the registration holder within the period preceding the application for re-registration.
Stage 2: Application for re-registration of medical device
As it was mentioned before, the application for re-registration of a medical device should be submitted via the online application system. The appropriate function will become available to the registration holder one 1 before the expiration date of the current registration. The authority also mentions that this function will not be available in case there are pending applications, e.g., change notification (both these applications cannot be submitted together as well). Once the re-registration process has been commenced, change notifications would not be accepted until completion of re-registration.
Requirements and Flow
The document also describes the requirements related to the re-registration, as well as the overall process flow. In particular, the matters addressed in the guidance include the following ones:
- Determination of the regulatory status of the product. First of all, the party responsible for a product in question should determine whether it falls within the scope of the medical devices regulatory framework. In this respect, the authority refers to the appropriate guidance document.
- Determination of the class of a medical device under the applicable risk-based classification. Once it is confirmed that the product in question is a medical device, it is necessary to determine its class based on the intended use and risks associated thereto. There are guidance documents dedicated to medical device classification issued by the MDA as well.
The above matters are the general ones and are not part of the re-registration process itself, but the general requirements that are prerequisites for the subsequent re-registration.
As was mentioned before, as the very first step, the registration holder should apply for a conformity assessment to be carried out by the conformity assessment body. The authority states that this is not required for Class A (low-risk) medical devices. As a result, upon completion of the conformity assessment, the CAB should issue a certificate of conformity accompanied by the appropriate report.
Once all the information and documentation required for re-registration is in place, the registration holder may proceed with the submission of an application via the online system. For this purpose, the registration holder should provide:
- Information about the intended use/indications for use for the medical device in question (the authority additionally emphasizes that they should remain unchanged since the initial registration);
- Details about medical device grouping where applicable;
- Validation report addressing the matters related to sterility or measuring function, and/or biocompatibility testing report (if applicable due to the nature of the device and its intended use);
- Common Submission Dossier Template (CST) filled in as explained in the appropriate guidance, together with the supporting documents.
- Pre-market Clearance/Approval;
- Labeling samples;
- Additional details in case of a combination product;
- Declaration on changes to the medical device;
- Medical device registration certificate;
- Information about the medical device manufacturer;
- Conformity assessment certificate recently issued by the CAB;
- Information related to post-market surveillance and vigilance, including the details about incidents (both ongoing and resolved);
- Declaration of Conformity.
In summary, the present MDA guidance describes in detail the approach to be applied by a registration holder when applying for the re-registration of a medical device it is responsible for. The document provides an overview of the applicable requirements and outlines the scope of documents and information to be submitted.
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