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INDIA SETS REGISTRATION DEADLINE FOR ULTRASOUND EQUIPMENT

India’s Central Drugs Standards Control Organization (CDSCO) has officially added ‘ultrasound equipment’ to the Notified list of medical devices that require pre-market approval in India. As seen in previous Notifications, the CDSCO is expected to release guidance of risk classification and generic intended use for ultrasound equipment.

Manufacturers and importers of these devices will need to obtain an Import Licenses (Form MD-15) under the Medical Device Rules, 2017 to maintain market access. Products without valid license may not be imported and marketed after November 1, 2020.

Suggested actions:

  • Identify any devices in your portfolio that utilize ultrasound technology
  • Confirm if the intended use matches those listed in the CDSCO guidance document (when available)
  • Prepare for application submission for applicable devices no later than January 1, 2020 to ensure licenses are in place by November 1, 2020

The mandate was published in the Gazette of India on October 16th, 2019 by the Ministry of Health and Family Welfare (Department of Health and Family Welfare). The published announcement constitutes Gazetting, officially implementing the new policy.The resolution to regulate ultrasound equipment was originally raised 21 months earlier at the February 12th, 2018 Drugs Technical Advisory Board (DTAB) meeting.

Asia Actual has a strong regulatory team in India helping companies stay informed and navigate the regulatory changes in India’s dynamic and complex market. Please contact us here with questions or service inquiries.  

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 COMPLIANCE MAINTENANCE: NOTIFIED BODY CHANGE

Given recent conditions of Brexit, many companies are impacted with changes regarding their notified body. This change ultimately changes the CE Mark on labeling, thus requiring amendments to any existing Import Licenses in India.

In order to remain compliant, our experts suggest to follow the post approval changes as per the Medical Device Rules 2017 (page 59)

Per the post approval change Rules, there is no specific  guidance  on “a change in number on the CE Mark/ Change in Notified Body”. For instance, even though the change of Notified Body from BSI UK to BSI Netherlands may not  affect quality in respect of its specifications, indication for use; performance and stability of the medical device, it may still be considered a major change as there will be changes  to labels  (refer point below). It may also be that the approval itself is based on the CE mark (EU nation FSC submitted at the time of registration in India) and in such a case the regulator may deem this to be a major change.

Further, if we see options under post-approval changes in the online system, then for Import Licenses in Form MD-14, following options appear:

Therefore, the suggestion is to select Category 7: change label excluding change in font size, font type, color, label design

Action For Major Changes

The authorized agent, shall obtain prior approval from the Central Licensing Authority before any major change, as specified in the Sixth Schedule, is carried out and the Central Licensing Authority shall indicate its approval or rejection within sixty days.

If no communication of approval or rejection as referred to in clause above is received within the stipulated time from the Central Licensing Authority, such change shall be deemed to have been approved.

Documentation Required Would  Include:
  1. Notarized letter from Manufacturer on their letterhead, addressed to the CDSCO explaining the details of the  change and circumstances leading to the change. Letter must confirm that the change is restricted to a change of address and further confirm that there are no changes whatsoever to previously submitted site master file and device master file; no changes in manufacturing site, device registered in India, device intended use, materials of construction, manufacturing and testing processes, performance, safety, risk class, stability, biocompatibility, shelf life etc.
  2. Notarized copies of new certifications issued by The Notified Body, notarized CE Certificate, ISO 13485 Certificate, CE Full Quality Assurance Certificate, CE Design Examination Certificate, as applicable.
  3. Confirmation that this change does not require an approval in the country of origin. If it does need approval in the country of origin, then notarized evidence of such approval is to be submitted.
Contact Asia Actual

Asia Actual is available to answer questions and help navigate you through any compliance maintenance issues you may face. Contact us to arrange an initial conversation.