Philippines Proposes New Fees for Medical Device Registration

The Philippines Department of Health published a draft schedule of fees to be charged for medical device registrations under the new Rules next year. As per Administrative Order 2018-0002, medical devices will be classified by increasing risk from A to D. The new registration fees will have three components that vary by risk classification as below:

Classification Type            Application   Evaluation Fee   Annual Retention fee

1.      Class A Notification              PhP 5,000         PhP 10,000             PhP  2,000

2.      Class B Registration            PhP 10,000       PhP 20,000             PhP  5,000

3.      Class C Registration            PhP 15,000       PhP 45,000             PhP  9,000

4.      Class D Registration            PhP 30,000       PhP 60,000             PhP 12,000

While not exorbitant by regional standards, the proposed changes do represent a significant increase in registration costs in the Philippines. Under the old Rules, government fees to process a Certificate of Product Registration (CPR) were PhP 1,500 for the initial application which was valid for 1 year and then PhP 5,000 for the renewal application which was valid for 5 years. By way of comparison, the 5-year regulatory fees for a CPR total about US$140, while the 5-year regulatory fees for a Class C Registration would total US$1,962.

A meeting was held to solicit stakeholder feedback on June 28th. Finalization of the guidance document on fees is expecting in the coming weeks.

Please contact Asia Actual with questions or support requests from our team in Manila.

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Philippines Announces New Medical Device Regulations

The Philippines Department of Health has launched new medical device regulations as announced in Administrative Order 2018-0002 dated January 26, 2018. The effective date is expected to be April 1, 2018, fifteen days after publication in two newspapers of general circulation. Medical device manufacturers are advised to take appropriate action to maintain market access for their devices in the Philippines.

The new system will be implemented in phases. At first, all Class A device will be required to obtain a Certificate of Medical Device Notification (CMDN). The same requirement applies to new registration applications for notified devices (those that previously required a Certificate of Product Registration). Manufacturers or their local authorized agents should have a 12-month grace period to comply before losing market access.  All current Certificates of Product Registration (CPR) will remain valid until their expiry date.

Then in Phase 1 implementation of the new requirements, all non-notified Class B, C and D devices will be required to obtain a CMDN. In Phase 2, Class D devices will be required to meet the stricter standards of a Certificate of Product Registration (CMDR). Finally, in Phase 3, all Class B and C devices will be required to obtain a CMDR. No information has yet been released on the timing of these phases.

Technical data requirements for the CMDR are similar to those of the CPR, but data must be formatted as per the ASEAN Common Submission Dossier Template (ACSDT). Another significant change will be to product grouping which is expected to be more generous under ASEAN MDD guidelines. Additionally, the CMDN and CMDR will be valid for 5 years.

Manufacturers are advised to determine the classification of all devices of interest for the Philippines market to confirm which phase will apply to each.

Further guidance is exepected in the coming weeks and more information including a full copy of AO 2018-0002 is available on the Philippines page of the Asia Actual web site.

Please contact us with questions or support requests from our team in Manila.

The Philippines FDA Streamlines Amendment Submission Process

On December 15, 2017 the FDA released guidance that provides for streamlining of the submission process for CPR amendments.

Currently, a single license holder is limited to 5 application submissions per week.  This practice was established so that large license holders would not monopolize CDRRHR resources.

Under the new guidance, qualifying CPR amendment applications can be grouped together in a single submission. For example, a change to the legal manufacturer’s address that applies to 20 CPRs may now be submitted at one time as opposed to over 4 weeks as was previously required.

A copy of Philippines FDA Circular 2017-014 is available at the bottom of the Philippines page of the Asia Actual web site.

Philippines Implements New Customs Clearance Procedure for Radiation Devices

Radiation-emitting medical devices such as X-ray machines, MRIs, linear accelerators and ultrasound scanners are now subject to a new customs clearance release procedure administered by the Philippine FDA. The new procedure, announced through FDA Circular 2017-013 on November 16, 2017, with immediate effect, replaces a similar process overseen by the Bureau of Customs.

For each shipment, importers of radiation-emitting devices must obtain a Clearance for Customs Release (CFCR) certificate issued by the FDA’s Center for Device Regulation, Radiation Health, and Research (CDRRHR). Applications will be processed within 3 working days for a fee of US$6 (Philippine Peso 300) per device.

One of the required elements of the CFCR application is a certificate of product registration issued by the national authority in the country of origin.  This document must be Authenticated by the Philippines embassy in the country of origin. Sufficient time should be allocated to fulfill this requirement.

A copy of FDA Circular 2017-013 is available at the bottom of the Philippines market page on Asia Actual’s website.

PHILIPPINES TO BAN POWDERED SURGICAL AND EXAM GLOVES

With FDA Advisory No. 2017-180 issued on June 20, 2017 the Philippines government announced intentions to gradually switch to power-free gloves.  A full ban of powdered surgical and examination glove will go into effect on January 1, 2019 effecting the importation, distribution and sale of specified devices.

This action comes in follow up to an FDA Advisory from earlier in the year outlining the risk associated with powered gloves.

A copy of FDA Advisory No. 2017-180 is available on the Philippines page of the Asia Actual website.

The Philippines FDA Publishes New Guidance on Medical Device Recalls

The Philippines FDA has published a Circular clarifying medical device recall requirements referenced in sections 5 (k) of the FDA Act of 2009. The requirements will go into effect in September of 2016.

The Circular provides guidance on how to conduct a recall in the Philippines and criteria for recall triggers. Also included is information on the composition and responsibilities of the Product Recall Committee and Market Authorization Holder.

Other steps toward harmonization are expected early in the new year.

A copy of the full FDA Circular 2016-012 is available here.

The Philippines FDA No Longer Requires Physical Samples for Medical Device Registration

Product samples are no longer required for The Philippines medical device registration process as part of the application requirements. Adequate pictures or line drawings may be used in lieu of physical specimens for registration. This change streamlines the application process by eliminating the need to import an unregistered medical device.

Details available here.

The Philippines Appoints New FDA Director General

President Rodrigo Duterte appointed Charade Galang-Puno as the new Director General of the Philippines Food and Drug Administration. Dr. Galang-Puno is one of 42 appointees sworn in on Monday, August 15 at the Malacañang Palace in Manila.

No significant changes to medical device policies or procedures are expected due to the new appointment. The Philippines remains on course with efforts to harmonize their medical device regulations in accordance with the ASEAN Medical Devices Directive.

Philippines FDA Moves to Streamline Submission Systems for Device Registration and Licensing

This month, the Center for Device Regulation, Radiological Health and Research (CDRRHR) has relocated from the Department of Health in Manila to new facilities within the FDA central compound in Alabang.

The change significantly involves medical device registration applications now being filed at the FDA Public Assistance, Information, and Receiving (PAIR) Unit as of July 19, 2016. As per their procedures, only electronic copies of applications and supporting documentation are now required.

These changes follow on the heels of a new, on-line notification procedure for updating the License to Operate to reflect new sources, a prerequisite to a new Certificate of Product Registration application.

To multinational manufacturers these changes should mean slightly faster market access for new devices as a result of more efficient processing of device registration and licensing applications.

4 Product Development Decisions that Impact Sales Performance in Asia

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US medical device manufacturers typically launch new products in Asia only after establishing success in the US and Europe. However, decisions made in the product development process have significant impact on regulatory costs, time to market and ultimately sales results in Asia. Address these four points to ensure fastest time-to-revenue in Asian markets.

Incorporate Asian Requirements into Product Testing
Conformance testing certificates are a common element of medical device registration applications. In most Asian regulatory systems, test reports used for US and European device registration are sufficient, with notable exceptions. South Korea and other markets require CB Scheme certification for electrical safety testing certificates. Further, testing records should be generated based on a country’s electrical supply (e.g., 220V/60Hz and/or 380V/60Hz). In Indonesia, Certificates of Analysis require numeric test values as well as a pass/fail designation. In China, in addition to having a complete set of test certificates to international standards, registration of Class II and III devices will require test certificates generated from one of ten local CFDA-certified test laboratories.

Design Your Clinical Trial to include Asian Requirements
If you must conduct a clinical trial in support of FDA Approval or CE Marking, confirm the data generated will also be acceptable for device registration in Asia. The Pharmaceutical and Medical Devices Agency in Japan offers a Clinical Trial Consultation just for this purpose. You may also consider the Harmonization by Doing program in Japan, which is designed to reduce the cost and time to register novel devices significantly by shifting 25% of your patient sample from a US clinical trial to Japan. The CSCSO in India will generally accept clinical data from outside India (except for drug-eluting stents, etc.), but may want to see ethnicity data. Again, Chinese registration of Class II and III devices will require a limited local clinical trial data.

Select a Fully Recognized Notified Body
Pick an ISO 13485 Registrar and CE Mark Notified Body that is recognized by competent authorities in Asia to avoid redundant QMS inspections and product conformity assessment fees. The Australian government has a mutual recognition treaty with the European Union whereby medical devices with CE Mark avoid local conformity assessment, greatly accelerating market listing in Australia. However, the Australian government has begun to deny recognition of certain Notified Bodies. In Japan, if your device qualifies for Pre-Market Certification (most Class II and some Class III devices), conformity assessment will be performed by a private Registered Certification Body. Seven of the fourteen RCBs also provide CE Mark in Europe. In Korea, a similar situation applies to most Class II devices. In Malaysia’s new and evolving regulatory system, all devices must undergo local conformity assessment, though the assessment for devices with reference country approval is greatly expedited. In these cases, manufacturers may request synergies if their Notified Body is also their RCB in Japan or Third Party Reviewer in Malaysia and South Korea.

Budget to Control Your Registration Certificate in Asia
In the US, Europe and Canada, the manufacturer on the labeling is considered the owner of the product registration certificate. In all other regulatory systems, the license/certificate/listing is owned or fully controlled by a local agent. In these markets, foreign manufacturers can only change or add distributors with the cooperation of the incumbent license holder. If the license is held by a commercial distribution partner, it is difficult to add, change or influence distributors in that market. Also, start-up companies with acquisition strategies have added incentive to control registration certificates to enhance acquisition value and enable the acquiring company to integrate new device/s into its direct sales channel. This situation can only be assured through an independent license holder.

Consult with Asia Actual for specific conditions that apply to your devices in Asia.