4 PRODUCT DEVELOPMENT DECISIONS THAT IMPACT SALES PERFORMANCE IN ASIA

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 Central Drugs Standard Control Organization (CDSCO) 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.

Examples:
    • 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.

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

PHILIPPINES FDA CHANGES IMPLEMENTATION PLAN FOR NEW MEDICAL DEVICE REGULATIONS

The FDA hosted a meeting on September 19th in Manila at which a revised implementation strategy for the new medical device regulations (Administrative Order 2018-0002) was rolled out. Significant changes were made to the original implementation plan announced back on February 22 to simplify and streamline transition to the new Rules.

 
Under the new plan, Class B, C and D Notified devices (as in listed in FDA Memo 2014-005) will require a Certificate of Medical Device Registration (CMDR) by November 3, 2019.  Likewise, all Class A device will require a Certificate of Medical Device Notification (CMDN) at implementation. Note that Certificates of Product Registration (CPR) issued under the current Rules will remain valid until their expiration date, and Certificates of Exemption (COE) will remain valid until November 3, 2021.
  1. Notified medical devices will be re-classified according to AMDD risk classification
  2. Validity of initial CMDN & CMDR will be 5 years
  3. A single application for a medical device system, family or multiple manufacturing sites is allowed (manual submission only), but will generate multiple CMDR/N
  4. Government processing fee for initial CMDN/CMDR application is PhP7,500 (about US$150)
  5. All Medical Devices and IVD that are not included in the scope of initial implementation shall be considered non-regulated products; importers License to Operate (LTO) may be provided for customs clearance in lieu of a COE.
  6. Technical data requirements are as per ASEAN MDD Common Submission Dossier Template (CSDT)
  7. Administrative data requirements include:
    • Letter of authorization copy with Notarized Declaration Letter of Authenticity
    • ISO 13485 copy with Notarized Declaration Letter of Authenticity
    • Requirement for Certificate of Free Sales (CFS) has been eliminated
    • Copy of registration in country of origin with Notarized Declaration Letter of Authenticity
    • Color picture of the device from all sides

The FDA will release written guidelines to make these changes official.

Asia Actual has a strong regulatory team in Manila to help device manufacturers stay informed and compliant with regulatory changes. Please contact us with questions or support requests.  

PHILIPPINES TO HOST ASEAN MEDICAL DEVICE COMMITTEE MEETING / TRAINING

The 8th ASEAN Medical Device Committee Meeting (AMDN) will take place in Manila from August 4-8, 2019. The meeting will be hosted by the Philippines Association of Medical Device Regulatory Affairs Professionals (PAMDRAP) together with the Philippines Food and Drug Administration (FDA).

Government regulators and technical committee members will gather for closed door meetings.  At the same time, Industry Training Sessions will be held on Wednesday, August 7th and Thursday, August 8th including a Public-Private Forum on Thursday afternoon from 2:00 to 5:30.  The full program will conclude with a Gala Dinner on Thursday evening.

Industry stakeholders are invited to attend the trainings, forum and Gala dinner. Information on registration process and fees are available here: www.pamdrap.org/amdc2019. 

Asia Actual personnel will be in attendance and report on significant developments. Contact us to arrange a briefing.

PHILIPPINES DELAYS LAUNCH OF NEW MEDICAL DEVICE REGULATIONS

The Philippines FDA intended to implement the first two phases of the new medical device regulatory system (known as Administrative Order 2018-0002) on April 11, 2019, however the implementation date has been delayed.  Extra time is needed for the CDRRHR to finalized guidelines for classification and grouping, etc.

No formal guidance on the new target implementation date has been announced, but it is expected to be several weeks later. In the meantime, the CDRRHR will continue to accept and process Certificate of Product Registration (CPR) and Certificate of Exemption (COE) applications under the current Rules.

Details of the AO 2018-0002 requirements were reported earlier and available on the Asia Actual website here

Asia Actual has a strong regulatory team in Manila to help device manufacturers stay informed and compliant with regulatory changes. Please contact us with questions or support requests.

PHILIPPINES NEW MEDICAL DEVICE REGULATIONS TO LAUNCH IN APRIL

Today the Philippines FDA provided important guidance related to the new Medical Device Regulations at a public forum held in Manila. The target date for implementation of AO 2018-0002 was announced for April 11, 2019. At that time, Class A, B, C and D medical devices will require a Certificate of Medical Device Notification (CMDN) in order to be imported and placed on the market in the Philippines. The grace period for compliance will be announced in March and expected to be 12 months.

Certificates of Product Registration (CPR) issued under the old Rules will remain valid until expiry at which point a license renewal application will generate a fresh CMDN. Certificates of Exemption (COE) issued under the old Rules will remain valid until an announcement by the FDA. The timing of this announcement has not yet been determined but likely to be several months to 1 year in the future. IVD devices are not affected by the new Rules.

Government processing fee for the CMDN will be based on the old Rules (e.g., US$175 covering five years) at first and then transition to the new risk-based fee structure floated back in July of last year (ref. article available here).

Official processing times will remain at 180 working days due to the high anticipated application volumes, however actual review times should be much faster.

Once implementation is made official, FDA will no longer accept applications for CPR or COE. However, any CPR or COE applications submitted prior to the implementation date will processed as normal.

Implementation of the new Rules is being conducted in phases. These changes represent Phase 0 and Phase 1 of the implementation plan announced in January of last year (copy of document available here ). Timelines for Phase 2 and 3 in which Class B, C and D devices will require the more comprehensive Certificate of Medical Device Registration (CMDR) have not yet been announced.

Important questions remain about classification, grouping, the validity of the products under COE, the management of the new fees, etc. Clarifications on these points are expected in March.

Asia Actual has a strong regulatory team in Manila to help device manufacturers stay informed and compliant with regulatory changes. Please contact us with questions or support requests.

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.

www.asiaactual.com

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.