Food and Drug BlogRegulatory AffairsRegistering medical device products in the Philippines

March 8, 20210
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The Fitch Solutions has reported that the Philippines’ medical device market is expected to grow by 8.8% in US dollar terms by end of 2024 despite the on-going pandemic. That’s about USD 884.3million.

The huge market size and promising growth always attract investors and they swarm in like predators on a target. When Covid-19 first struck the country, a lot of these products were introduced in the market ranging from COVID-19 test kits to face masks with the most ridiculous claims. This influx has bolstered the Food and Drug Administration (FDA)’s stance to warn not only the general public but the healthcare professionals as well.

The Center for Device Regulation, Radiation Health and Research (CDRRHR) is the authorized body in giving any certification proving that a product is compliant with the documentary and technical requirements of FDA.

In compliance with DOH Administrative order No. 2018-0002 (Guidelines Governing the Issuance of an Authorization for a Medical Device Based on the ASEAN Harmonized Technical Requirements), FDA issued Circular No. 2020-001 last March 17, 2020. One of the major changes in the new regulation is the replacement of Certificate of Product Registration (CPR) with different types of authorization for medical devices:

  1. Certificate of Medical Device Notification (CMDN) — refers to the authorization issued for a medical device that complies with all the requirements for Notification of a medical device. The CMDN is issued for medical devices that will fall under class A.
  2. Certificate of Medical Device Registration (CMDR) — refers to the authorization issued for a medical device that complies with all the requirements for Registration of a medical device. The CMDR is issued for medical devices that fall under classes B, C, and D.
  3. Certificate of Medical Device Listing (CMDL) —- refers to the authorization issued for a medical device that is intended for research, clinical trial, exhibit, donation, etc. and that is not intended for sale.

CMDN and CMDR are valid for five (5) years and can be renewed thereafter.

Medical devices are classified according to the ASEAN Consultative Committee on Standards and Quality — Medical Device Product Working Group (ACCSQ-MDPWG) which is based on the level of risk:

Classification

Risk

Type of Certificate

Class A

Low risk

CMDN

Class B

Low-moderate risk

CMDR

Class C

High-moderate risk

CMDR

Class D

High risk

CMDR

Certificates of exemption will no longer be given for non-registrable products. Any businesses importing and/or distributing or manufacturing such devices should obtain a License to Operate (LTO).Under this new new regulation, Certificates of Exemption for Class A medical devices would be valid until November 3, 2021, or within two (2) years after the new regulation’s implementation, whichever date comes earlier. Subsequently, all previously issued Class A Certificates of Product Registration must remain valid during the original term of validity and should be replaced by CMDN instead of renewal.

A group of related medical devices may be applied for registration in a single application. As a consequence, however, each device will be issued its own license and the grouping may be tricky if you’re unfamiliar how to do so.

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DISCLAIMER: Note that only registered businesses in the Philippines are allowed to apply for LTO and product registrations. While we try our best to update each article, we highly recommend to always check the FDA website for timely news on registration processes and requirements. Or better yet, consult with us!

Are you ready to register your medical device products with FDA? Do you need assistance? Book a FREE 30-minute consultation with one of our experts by calling +632 8551 9012 or send an email to info@tripleiconsulting.com.  

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