Philippines Food and Drug Administration (FDA), the national authority responsible for medical devices market regulation, has announced the implementation of a new regulatory framework for medical devices.
New Medical Device Regulation: General Principles and Objectives
The obligatory medical device registration was implemented in 2014-2015 when the Philippines FDA issued several documents introducing regulatory procedures and set forth a list of devices subject to registration in order to be placed on the market. According to the agreement on harmonized medical device regulations and common technical documentation, any device intended to be marketed in the Philippines should comply with the requirements set forth by the ASEAN Agreement on Medical Device Directive (AMDD) and the appropriate Annexes thereto. Later in 2018 the official guidelines were issued to assist medical device manufacturers, importers and other parties involved in maintaining compliance with AMDD. It is also important to mention that harmonized medical device regulation also includes the Common Submission Dossier Template (CSDT).
The new guidance is intended to commence the implementation of the new framework set forth in the aforementioned regulations. The scope of the document covers all products subject to registration in accordance with the appropriate list, including in vitro diagnostic (IVD) devices. In particular, the document describes the most important aspects related to application submission and covers the issues related to manufacturing, importing, distributing, use, examination, testing or other operations performed in relation to medical devices.
The document also provides the risk-based classification of medical devices, namely:
- Class A – Low risk,
- Class B – Low-moderate risk,
- Class C – Moderate-high risk,
- Class D – High risk.
New Medical Device Regulation Novelties
According to the new regulatory framework, the following types of applications would be acceptable:
- Certificate of Medical Device Registration (CMDR) applicable for the Class B, C and D medical devices included in the list of medical devices subject to registration,
- Certificate of Medical Device Notification (CMDN) applicable for the Class A medical devices regardless of being listed or not, and
- Certificate of Medical Device Listing (CMDL) for certain specific categories of medical devices (e.g. ones intended for clinical trials of research, as well as personal use and innovative medical devices).
All applications should be submitted to the Center of Device Regulation, Radiation Health, and Research (CDRRHR), the FDA department directly responsible for registration affairs.
The document also provides that Certificates of Exemption for Class A medical devices would be valid for a certain period of time (until November 3, 2021, or within two years after the new regulation enters into force depending on which date would be earlier). At the same time, all Class A Certificates of Product Registration issued previously would remain valid within the initial validity period and then should be replaced by CMDN instead of renewal. The Certificates of Exemption would be no longer issued – the device eligible for the exemption is not included in the list of devices subject to registration and thus exempted from the obligatory registration framework. At the same time, an entity operating with such devices should obtain a License to Operate to confirm the compliance with applicable requirements.
Implementation Aspects and Summary
The document contains a new list of medical devices subject to registration that supersedes the appropriate list introduced in 2014 by the previous regulation framework. The same rule should be applied to any other provisions: in case of any contradictions the provisions of the new regulation should prevail.
The new regulation provides the following:
- All medical devices eligible for the notification procedure should be subject to reclassification in accordance with the new risk-based classification introduced by the AMDD.
- The initial validity period of CMDN and CMDR would constitute five years with the possibility to renew.
- A group of related medical devices could be submitted to the registration composed into one application. However, as a result, each of the devices would be assigned with its own independent certificate.
- The initial application fee equals approximately $150 and the renewal fee is approximately $100, while the authority reserves the right to revise fees payable for registration, re-registration and other related services from time to time.
- The other devices included in the list of medical devices subject to registration should be deemed exempted from registration. As it was mentioned before, any company operating with such devices should apply for the License to Operate. For example, such a procedure could be necessary for the importer in order to pass customs clearance for exempted devices.
- The list of documents to be provided in the course of application submission includes, among others, the following: authorization letter and other necessary confirmation of the authorization for the representatives, ISO 13485 certificate, confirmation of successful registration in the country of origin, and also the color images of the device detailed enough to show all its sides. It is also important to mention that all the documents should be notarized. At the same time, it is no longer needed to provide a Certificate of Free Sale.
According to the rules regarding the exemption from registration, if the device contains any of the devices included in the list of exempted devices as a part, such medical devices should be subject to registration.
According to the rules regarding the possibility to file a single application for several devices providing that each device would be registered with a separate certificate, such an approach could be used for:
- medical devices accompanied by the accessories that would be marketed separately, or
- the device manufactured on different production facilities, or
- group of devices constituting a complex system, or
- medical devices that differ in the terms of raw material used or design while being intended for the same purpose, or
- medical devices intended for different purposes but similar in the terms of raw materials used.
In this case, an applicant would have to pay a fee that equals the general registration fee payable for all applications as being submitted separately. The main criteria implemented by the regulation to define whether the particular device should be subject to the regulation under the medical device framework is the intended purpose: if a product is not intended to be used for the medical purpose it should not be deemed as a medical device.
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