Home About Qualtech NEWS PHILIPPINES: PFDA Drafts Guidance on Labeling Aimed at Aligning Itself with AMDD Requirements – May, 2019
PHILIPPINES: PFDA Drafts Guidance on Labeling Aimed at Aligning Itself with AMDD Requirements – May, 2019

May 13, 2019

Recently, the Philippine FDA has published a newly drafted guidance for Labeling. The new guidance was catered to effectively communicate safety instructions to end-users and patients alike, as well as to standardize labeling requirements well aligned with the labeling provisions set in the AMDD. This guidance applies to all medical devices, including in-vitro diagnostics (IVD) currently being marketed in the Philippines.

The general provisions concern itself on the legibility of salient information related to device use (e.g., where the label shall be placed, font type and size, color contrast, format), comprehensibility of information commensurate to the level of understanding of the end-users/patient (e.g., medium of instruction, jargons, use of internationally-recognized symbols), provision of labels/package insert in paper version, visibility of contraindications, precautions/warnings as to reflect residual risks, and misinformation due to false claims. All general information shall be located depending on a particular medical device and its intended use.

1 Things to consider 1

 

This draft guideline is bound to take effect after fifteen (15) days following its official publication. Upon implementation, PFDA shall strongly enforce this guideline by way of mandating all manufacturers to adhere to labeling requirements given below, prior to the device’s introduction, sale, distribution and marketing in the Philippines upon. Further, any violations against this guideline shall serve as a ground for suspension, cancellation or revocation of registration license issued by PFDA, along with imposition of fines.

We compare the requirement of PFDA new labeling requirements with AMDD and organize below table:

Table 1 PH May2019

 

Specific Guidelines were separately provided for Medical Devices and In-vitro Diagnostics. Most requirements were observed to be in parallel with the requisites given under Annex 7 of AMDD.

Table 2 PH May2019

 

What’s new with these requirements?

Currently, the requirements in labeling are not that intensive as compared with the drafted guidelines. Current requirements are still included in the draft guidance, with very few differences. These are summarized in the table below:

 

 

Summary

There’s no doubt that the newly-drafted labeling guidelines closely approach that of AMDD requirements, with slight additions based upon the national requirements as dictated by the needs of the country. The formal publication, effectivity and implementation have not been set yet at the time of this writing, however, it could safely be assumed that it would be enacted soon as the AO 2018-0002 implementation kicks in.

As the guideline is still on its fourth draft, manufacturers have still got an ample time to prepare for these requirements and provide helpful insights that could help in the efficient and feasible implementation of the said guidance.

 

References:
ASEAN Medical Device Directive

Draft of New Philippine Labeling Requirements


Tags:
Philippine Registration, New Philippine Labeling Requirements, ASEAN Medical Device Directive, Philippine New Regulations

 

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Home About Qualtech NEWS PHILIPPINES: PFDA Drafts Guidance on Labeling Aimed at Aligning Itself with AMDD Requirements – May, 2019