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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.  

HONG KONG LAUNCHES EXPEDITED MEDICAL DEVICE REGISTRATION PILOT PROGRAM

On August 20, Hong Kong’s Medical Device Control Office (MDCO) posted information about a pilot program for the expedited review for Class II, III and IV medical device listing applications.  Qualified applications will be accepted from this September 1st to June 30th of next year.  The expedited review is expected to shorten the target review time to 8 weeks.

In addition to the standard documentation requirements, the Expedited scheme also requires a Device Profile Form (see template here) and Declaration Letter.

To summarize qualifications, products must have:

  1. no reported deaths or serious injury associated with the device (local and worldwide)
  2. no active recalls, field safety corrective actions or adverse incidents (local and worldwide)
  3. two or more valid reference country approvals for at least three years from Australia, Canada, the EU, Japan, or the US (note Australian approval based on the Mutual Recognition with the EU approval will not be counted as a separate approval)
  4. at least one substantially equivalent device listed in the Hong Kong Medical Device Administrative Control System (MDACS)

Each Local Responsible Person can have 2 expedited applications in process at one time.

Application queries by the MDCO must be closed within 2 weeks of receiving notice. If not, the application may be moved to a standard application review, but will remain against the 2-application quota for the LRP until approved.

Likewise, if the application is withdrawn, the applicant’s quota will be frozen for 1 year from the date the application reached MDCO. So only applications with high confidence of success should be submitted.

Asia Actual has fully licensed office in Hong Kong (including a Radio Dealers License for importing devices that include wireless technology) staffed by high level regulatory professionals. Please contact us with questions about the new program or our regulatory and Local Responsible Person (license holding) services.

INDIA PLANS TO REGULATE ALL MEDICAL DEVICES

At the April 2nd DTAB meeting, the DCGI presented a proposal to regulate all medical devices over a 42-month period. Non-Notified devices would require registration in a phased in approach. This would allow an 18-month voluntary registration period after which class A and B devices would have 12 months to obtain an Import License (MD Form 15) prior to importation.  Class C and D devices would have 24 months to meet the same requirement.

Implementation could happen quickly. The proposed plan closely matches details that were discussed at a meeting hosted by the Central Drugs Standard Control Organization (CDSCO) held on February 8, 2019 with industry stakeholders.  Once the plan is endorsed by the DTAB, the MOHFW is expected to establish the implementation date quickly. Perhaps as early as the third quarter of 2019.

Voluntary registration would involve typical administrative documents such as reference country approval certificate, ISO 13485 certificate, etc.  The voluntary Registration Certificate carries no processing fee and no expiry date.  However, once registered the local license holder would be required notify the CDSCO and Materiovigilance Programme of India (MvPi) of Serious Adverse Events (SEA) occurring in India.

The CDSCO review process to generate a MD Form 15 typically takes 6 to 9 months with 6 to 8 weeks of application preparation. To be safe, manufacturers should begin the MD Form 15 application process 12 months before any deadline.

Manufacturers of non-Notified medical devices are advised to evaluate their products of interest for India and begin to build their application files for a Registration Certificate and Import License.

Asia Actual is available to answer questions or help register your devices when the new requirements take effect. Contact us to arrange an initial conversation.

KOREA CHANGES MEDICAL DEVICE QUALITY SYSTEM REQUIREMENTS

The Korean Ministry of Food and Drug Safety (MFDS) announced changes to the requirements for Korea Good Manufacturing Practice (KGMP) certification.  Any company applying for new or renewal KGMP certificates after July 1, 2019 will be subject to the following new requirements:

  1. KGMP reference standard will be changed from ISO 13485:2003 to ISO 13485:2016
    • While certification to the standard is not required, quality systems must demonstrate compliance to the same
  2. On-site inspection of contract manufacturing sites will increase
    • The provision requiring only one contract manufacturer to be subject to an on-site inspection has been eliminated. Formerly, when a legal manufacturer employed two or more contracting manufacturers, an on-site auditing would be conducted to one contract manufacturing site and the other sites would only be subject to document audits. This change has the potential to add significant time and cost to the compliance requirements for manufacturers that employ multiple outsourced manufacturing facilities.
  3. Additional documents will be made mandatory for KGMP application
    • Several documents have been added to the certification application aimed at closing the gap between paper audit and on-site audit requirements. The MFDS is expected to provide guidance on the format for items 5 and 6 before July 1, 2019. The additional documents are:
1Organization chart
2Document log listing the quality documents
(document name an revision information must be identifiable)
3Quality control summary
4Declaration of conformity
5Summary of Validation of Processes for Providing Production and
Services related to the product for KGMP certification
6Summary of Control of Monitoring and Measuring Equipment
related to the product for KGMP certification

Korea has a unique quality system assessment process for medical device manufacturers.  Since April of 2012, KGMP certificates are a required element of Class 2, 3 and 4 medical device registration applications for foreign manufacturers. Certificates are product category, facility and license holder specific; and must be renewed every three years. Certificates are required for the legal manufacturing site as well as any contract manufacturing site involved with a critical manufacturing process.

Medical device manufacturers active or interested in the Korean market should be prepared for these changes.

Contact us!

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

INDIA TO REGULATE SURGICAL DRAPES AND GOWNS

At the April 2nd Drugs Technical Advisory Board (DTAB) meeting, the board deliberated upon and agreed to add (1) surgical gowns, (2) surgical drapes, and (3) incision drapes to the list of notified medical devices requiring registration with the Central Drugs Standards Control Organization (CDSCO) in India.

Next the Ministry of Health and Family Welfare must issue a Gazette Notification for the requirement to become official. Based on past experience,  it is expected to take approximately 5 months from a positive DTAB board resolution to Notification with a likely 12-month transition period for compliance. Manufacturers of these devices should take urgent action to prepare registration applications to maintain access to the Indian market.

Asia Actual has a strong regulatory team in Delhi to help companies stay informed and ahead of regulatory changes. Visit our market info page for the most up-to-date list of notified medical devices requiring registration.

We also provide efficient, transparent management of medical device regulatory, vigilance and importing activities in this dynamic market.

Please contact us with questions or service inquiries.Attachments area

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.