The article provides an overview of the draft guidance document describing the procedures related to certain certificates related to medical devices.
Table of Contents
The Medical Device Authority (MDA), a Malaysian regulating authority in the sphere of healthcare products, has published a draft guidance document dedicated to the requirements for the application of a Certificate of Free Sale (CFS), Manufacturing Certificate (MC), and Certificate of Free Sale for Export Only (CFS EO) medical devices. Once finalized, the document will provide an overview of the existing regulatory requirements, as well are recommendations to be taken into consideration by all the parties involved in operations with medical devices in order to ensure compliance thereto. At the same time, it is important to mention that provisions of the guidance are non-binding in their nature, nor are intended to introduce new rules or impose new obligations. The authority also reserves the right to make changes thereto, should such changes be reasonably necessary to reflect the corresponding changes to the underlying legislation.
Regulatory Background
Recommendations provided in the present draft guidance are based on provisions of the existing regulations in the sphere of medical devices, namely:
- Medical Device Act 2012 (Act 737);
- Medical Device Regulations 2012;
- Medical Device (Duties and Obligations of Establishments) Regulations 2019; and
- Medical Device (Advertising) Regulations 2019.
Under the general rule, any and all medical devices should be registered in order to be allowed to be imported, exported, or marketed in Malaysia. At the same time, the products that are initially intended to be exported are exempted from the said requirement. The scope of the guidance covers the aspects related to medical devices of all types, including in vitro diagnostic ones. Recommendations provided therein could be followed by all the parties involved in operations with medical devices interested in applying for the aforementioned certificates and obliged to comply with the respective requirements.
Terms and Definitions
First of all, the guidance provides definitions of the most important terms and concepts used in the context of the document including, inter alia, the following ones:
- Certificate of Free Sale (CFS) means certificate issued as proof of registered medical devices, are legally exported or distributed in Malaysian market, freely without restrictions, and approved by the Authority in the country [of] origin.
- Manufacturing certificate (MC) stands for a certificate issued to confirm that the medical device has been made by the specific manufacturer in Malaysia.
- Certificate of Free Sale for export only (CFS EO) is a certificate issued as proof of exempted medical devices under section 5 of Act 737, not been sold or distributed in Malaysian market, have obtained Notification of Export Only from the Authority to export their medical device to requesting country.
Apart from the ones listed hereabove, the document also provides definitions of such terms as “authority”, “contract manufacturer”, “manufacturer”, “medical device”, and “physical manufacturer”.
Requirements: Key Points
The document further highlights the most important aspects related to the applicable regulatory requirements to be taken into consideration by the parties involved. First of all, an entity interested in applying for one of the certificates described in the guidance should ensure the product in question meets the definition of a medical device and, consequently, should be subject to regulation under the respective framework. The said determination is described in detail in a separate guidance document issued by the authority. As the next step, the party responsible for a medical device should determine the applicable class of the device under the current risk-based classification for medical devices, as this would impact the regulatory requirements to be followed. The authority also mentions that medical device manufacturers are obliged to develop and implement a Quality Management System (QMS) which should comply with the requirements set forth by ISO 13485.
Application Process
In order to obtain one of the certificates described herein, an interested party should submit a request to the authority accompanied by the necessary documentation. Such a request should be submitted in electronic form via the respective portal for e-submissions operated by the authority. The present draft guidance outlines the scope of information to be included in such applications depending on the type of certificate requested.
For instance, when applying for a Certificate of Free Sale, an interested party should submit:
- A copy of establishment license;
- Proof of medical device registration (registration certificate);
- Medical device list (should include the name or brand name of the device in question, as well as its registration number).
When applying for a Manufacturing Certificate, an interested party should submit:
- Registrar of Companies (ROC) certificate of applicant;
- A copy of establishment license;
- Copy of QMS certificate (ISO 13485 or equivalent);
- Proof of medical device registration (Registration certificate);
- Copy of Invoice (evidence that this medical device is sold in Malaysia);
- Medical device list;
- Letter of declaration as OEM;
- Brochure.
The application for a CFS for export-only medical devices should contain the following elements:
- Acknowledgment of Notification for export only medical device;
- General information (including the indication of a type and class of a medical device, its name and description, as well as indications for use);
- QMS Certificate;
- Grouping details;
- Summary of technical documentation;
- Premarket approval;
- Post-market vigilance history;
- Declaration of Conformity (DOC).
In summary, the present MDA guidance provides an overview of the applicable regulatory requirements related to various certificates to be issued by the authority with respect to medical devices. The document also describes the applications to be submitted by interested parties and outlines the scope of documentation these applications should contain.
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