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Likewise, if the application is withdrawn, the applicant’s quota will be frozen for 1 year from the date the application reached MDCO.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.

INDONESIA CALLS FOR NEW ROUND OF E-CATALOGUE APPLICANTS

In response to the overwhelming interest to a June invitation for registered medical device license holder to request inclusion of their device/s in the 2019 e-Catalogue enrollment, the Indonesia Ministry of Health (MOH) has extended the application deadline. (formal announcement letter here)

Interested Import License (AKL) holders of a registered medical device/s have until 14:30 on Thursday, July 26th to prepare and submit an application at the MOH office at Meeting Room ULPYankes 4 floor, Adiyatma Building. Jl. H.R Rasuna Said Blok X5 Kan. 4-9, Jakarta 12950.

The MOH will process the applications and forward a list of suggested device categories to the Indonesian government procurement agency, LKPP, for eligibility for e-Catalgoue enrollment this year.

Required elements of this application include:
  1. Application letter
  2. List of products (template provided by the MoH)
  3. Original Scan of IPAK
  4. Original Scan of AKL
  5. Brochure, leaflet, and product information
  6. Documents submitted must be soft-copy on a USB stick

The LKPP’s planned acceptance of e-Catalogue listing renewal applications is on schedule.  However, the planned call for new enrollment applications has been postponed, but expected at any time.

Contact us:

Asia Actual’s office in Jakarta is monitoring the situation closely.  Please contact us for the latest updates.

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.

INDONESIA E-CATALOGUE ENROLLMENT DEADLINE JUNE/JULY 2019

The Indonesian government procurement agency, known as LKPP, has invited medical device companies to apply for any existing e-Catalogue contract extensions by July of 2019.  (reference LKPP No. 5265/D.2.2/05/2019)

Initial guidance from LKPP was that no new e-Catalogue applications would be accepted this year. However, in response to industry feedback, new e-Catalogue listing applications may be accepted on a limited basis under the following conditions:

  • Companies with interest in making application for a new e-Catalogue listing, must submit an application to the Ministry of Health (MoH) by this Friday, June 21. The MoH will then select among applicants and submit a list of device categories for new registrations to the LKPP this year. 
  • Medical device manufacturers with interest in new e-Catalogue listings should coordinate quickly with the holder of their Import Licenses (AKL) to make application this week to the MoH.  It is also advisable to begin assembly of the full LKPP e-Catalogue enrollment application as certain documents require Authentication from the Indonesian Embassy in the country of origin, which can take several weeks. 

The Ministry of Health applications requires the following documents (submitted in soft-copy on USB stick):

  1. Application letter with a list of products of interest (templates provided by MoH) (reference MOH No. KN.01.01/I.4/5945/2019)
  2. Original scan of importers Distribution License (IPAK)
  3. Original scan of product Import License (AKL)
  4. Product brochure, leaflet, and information 

The LKPP application intake will commence in July, followed shortly by price negotiation meetings with new e-Catalogue listings targeted for October.

Asia Actual is available to answer questions. Contact us to arrange an initial conversation.

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.

INDIA MOVES QUICKLY TO REGULATE ORGAN PRESERVATION SOLUTION

On April 2nd, the Ministry of Health and Family Welfare published a special notification requiring organ preservation solution to be registered as a drug with immediate effect and no grace period.

In order to import and sell organ preservation solution in India, products must now have in place a Registration Certificate (Form 41) and then an Import License (Form 10) as per the Drugs and Cosmetics Rules, 1945. The Review time for each application is approximately 6 to 9 months and 4 to 6 weeks respectively.

Previously organ preservation solution was considered a non-Notified medical device in India. Multiple No Objection Certifcates (NOC) were issued between 2010 and 2018 clarifying the non-Notified status of specific organ preservation solution devices.

Then at the February 12, 2018 Drugs Technical Advisory Board (DTAB) meeting, organ preservative solution was slated for Notification as one of the first medical devices to be newly regulated under the Medical Device Rules, 2017. At that time, it was expected to require an Import License (Form MD 15) to import and sell organ preservative solution in India by early 2019.

This Notification announcement (available here) represents a departure from the anticipated process to add devices to those that require registration in India. Manufacturers of currently non-Notified devices should be vigilant about pending registration requirements.

Contact Asia Actual with any questions or requests for support to register your devices in India.