Philippines Update – 2021
Welcome to the Arazy Group Medical Device Regulatory Update! Today’s update is from the Philippines. we will cover the update on the classification and list of medical devices that are required to be registered in January 2021. A Draft on the List of Class A, Medical Devices, for FDA registration, in the Philippines. An update on the implementation of a new regulatory framework in January 2021. An update on the transition period to import non-registrable medical devices in August 2021. The automatic 4-months extension for registration certificates, until public health emergency is lifted. Let’s review each update in detail.
According to the FDA Circular Number 2020-001, there are 137 product categories listed as registrable medical devices. However, through the new FDA Circular Number, 2021-001A, the product risk for 31 product categories from the previous list are re-classified and the resuscitator and ventilator product categories are also added.
Under the previous regulation, there was only one list to cover all product risk classification. This list had been updated from time to time, and last updated through the FDA Circular Number 2021-001A. However, there is no specific list for Class A medical devices. Under the new draft regulation, in addition to the previous list, there will be a specific list for class A devices that are subject to CMDN. If for some reason, a product is not included in the list, then the classification shall be based on its intended use and the classification rules of the ASEAN Medical Device Directive. The FDA however, will verify the classification proposed by the applicant, and reclassify if necessary.
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There are some Class B, C, and D products that are not included in the FDA Circular Number 2020-001. Such products are exempted from product registration and are considered as non-registrable. Although it is exempted, a certificate of exemption must be obtained in order to import and participate in a government bidding.
However, according to the FDA Circular Number 2021-002, non registrable products must now apply for CMDN, which is the registration procedure for class A registrable medical devices. The issued registration certificate will be valid for 2 years and must be converted to CMDR during the renewal process. However, the classification for non-registrable medical devices will follow the classification rules set by ASEAN Medical Device Directive.
To provide enough time for the industry to implement the new regulatory framework, the Philippines FDA has provided a transition period, wherein the companies may be allowed to import non-registrable medical devices and submit their CMDN application. Until March 31 2022, The importation of Class B, C, and D products without CMDN is still allowed. The FDA will start receiving the application for CMDN and the Certificate of Exemption will remain valid.
As of April 1st 2022, the importation of class B, C and D products without CMDN is still allowed, but with a condition that the CMDN application has been submitted. At this point, the certificate of exemption is no longer valid for the importation. By April 1st 2023, the FDA will stop receiving the CMDN applications and start receiving the C M D R applications. At this point, CMDN for Class B, C and D must be converted to CMDR. Therefore, more complex documents will be required for the registration. Moreover, Importation without approved CMDN will not be allowed.
To provide flexibility for the industry during the public health emergency period, registration certificates expiring between July and December 2021 will be granted an automatic 4-months extension. Under this new policy, the renewal application must be submitted within the 4 months extension. Failure to submit the application within the indicated time period will cause the applicant an additional charge. The extension however, will only be granted once.
That's it for our update today! If you have any comments or questions, please do not hesitate to email or call us. Check the contact us page on our website for an Arazy Group office near you. Follow Arazy Group on Linkedin to view other countries' regulatory updates, as well as the latest advancements in regulatory affairs technology. Stay safe and keep well.