The article provides an overview of the existing regulatory requirements related to the abridged processing of applications for medical devices.
The Food and Drug Administration (FDA) Philippines, a country’s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to the abridged processing of applications for registration of medical devices approved by the national regulating authority of any ASEAN (Association of Southeast Asian Nations) member country. The appropriate circular issued by the authority outlines the policy to be applied for such applications to streamline the regulatory processes and expand the availability of medical devices on the country’s market.
First of all, the authority mentions that according to the generally accepted good reliance practices (GReIP), reliance allows national regulatory authorities (NRAs) to make the best use of resources, build expertise and capacity, increase the quality of their regulatory decisions, reduce duplication of effort and, ultimately, promote timely access to safe, effective and quality assured medical products. Thus, the above means that when deciding on a marketing approval to be granted, national regulatory authorities may rely on similar decisions taken by other national regulatory authorities to reduce the time needed for a medical device to be approved for marketing and use, as well as the regulatory burden medical device manufacturers face when applying for marketing approval in each country. The present document describes the approach to be applied for the applications compliant with the ASEAN Common Submission Dossier Template (CSDT) under the ASEAN Medical Device Directive (AMDD).
It is further stated that the approach described in the present document is in line with the above mentioned regulations and principles. In particular, the guidance is intended to provide additional clarifications regarding the abridged processing of applications for the registration of medical devices in cases when the medical device in question has already been approved for marketing and use by a national regulatory authority by the AMDD-CSDT framework. The scope of the document covers Class B, C, and D medical devices for which approval of the regulatory authority is required for them to be placed on the market. At the same time, the abridged approval related to countries other than the ASEAN Member States falls outside the scope of the present guidance, together with the aspects related to in vitro diagnostic or refurbished medical devices.
Terms and Definitions
To assist the parties involved in interpreting and following the applicable regulatory requirements, the authority provides definitions of the most important terms and concepts used in the context of the guidance. Such definitions include, inter alia, the following ones:
- Abridged processing – expedited evaluation process of the FDA for registration of medical devices approved by the NRA of any ASEAN member country under the AMDD-CSDT requirements. This shortened evaluation process is based on the application of reliance.
- Reliance – the act whereby the regulatory authority in one jurisdiction takes into account and gives significant weight to assessments performed by another regulatory authority or trusted institution, or to any other authoritative information, in reaching its own. In this respect, it is important to mention that such an authority is still solely responsible for the decision taken, even if the decision is based on the information or assessment performed by another authority.
- The same medical device applies in case the medical device submitted to the FDA is exactly and consistently the same as in all its brand/model/manufacturer and/or technical documentation as the medical device approved by the reference NRA.
- Reference national regulatory authority (NRA) stands for the FDA counterpart regulatory authority of any ASEAN member country which approves medical devices based on the AMDD-CSDT requirements.
The document further describes in detail the policy authority intends to apply, and also provides additional guidelines to assist the industry representatives in understating such an approach. In particular, the authority mentions that as was mentioned before, the approach described herein could be applied only to Class B, C, and D medical devices. Furthermore, the FDA additionally emphasizes that the technical requirements and documentation submitted for review should be the same as those submitted earlier to the reference NRA during the initial registration.
The authority also outlines situations in which it is entitled to refuse by using the simplified procedure. Such a decision could be taken in the following circumstances:
- Receipt of any negative report on the medical device from other countries;
- When there are conflicting views or assessments from NRAs of other ASEAN countries on the same medical device; and
- Other circumstances may entail the FDA’s careful evaluation of medical device applications for registration.
Hence, in the above cases, a standard procedure is to be applied, providing that the authority will conduct a detailed assessment of the application submitted to ensure the medical device in question meets the applicable requirements in terms of safety and effectiveness.
Application Process in Detail
The authority also describes the procedure to be followed when applying for medical device registration under the abridged processing. In particular, it is stated that the applicant should submit technical documentation related to the device in question, together with the attestation and acknowledgment whereby the applicant acknowledges that in case of unauthorized changes to the product the authority reserves the right to suspend the establishment license granted to the applicant or registration certificate for the medical device in question.
Once the application is received, the authority will conduct a pre-assessment and, upon its successful completion, issue a payment order.
The authority additionally emphasizes that even in case the simplified process described herein applies, a separate evaluation would still be conducted to ensure the applicable labeling requirements are met.
In summary, the present guidance issued by FDA Philippines describes an accelerated procedure of medical device registration based on existing marketing approval granted by the foreign regulating authority in another ASEAN country. The document highlights the key points to be taken into consideration when determining the applicability of the said approach and also outlines specific aspects associated thereto.
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