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.

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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.

THAILAND TO REGULATE HAND SANITIZER AS A MEDICAL DEVICE

Thai FDA announced that hand sanitizer (alcohol gel) will require registration as a medical device (reference press released number สธ 1007/ว706 dated January 17, 2019). The change is expected to take place later this year when the new medical device classification guidelines are implemented.

Since 2011, hand sanitizer with alcohol content of 62.4% by weight or greater has required registration as a cosmetic device with the Bureau of Cosmetic and Hazardous Substances. When the new medical device classification system is implemented alcohol gel products will need to be registered with Medical Device Department of the Thai FDA.  At that time notified alcohol gel certifications issued by the Bureau of Cosmetic and Hazardous Substances will be cancelled.

The move to change the status of hand sanitizers was deemed necessary to prevent insufficiently strong products from being inappropriately used as a disinfectant in department stores, schools or hospitals to prevent the spread of contagious diseases.

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.

HONG KONG OPENS THE VOLUNTARY REGISTRATION SYSTEM TO CLASS B & C IVD DEVICES

Today (February 11, 2019) the Medical Device Control Office (MDCO) opened the voluntary device registration system to Class B and C IVD devices. Previously only Class D (high risk) IVD devices were include under the Medical Device Administrative Control System (MDACS).

A copy of the Guidance Notes for Listing Class B, C and D In Vitro Diagnostic Medical Devices (GN-06E (2019) can be found here.

The regulatory systems for IVD and medical devices is currently voluntary in Hong Kong and now open all but and Class A IVD devices Class I medical devices.

Manufacturers typically participate in the voluntary system to (1) gain a sales advantage as the Hospital Authority requires or gives preference to registered devices in public hospital purchasing decisions and (2) avoid confusion and delays that will come when the system becomes mandatory. To date more than 5,000 devices have been registered by the MDCO under the voluntary system.

Asia Actual has a office in Hong Kong staffed by experienced regulatory professionals. Please contact us with questions or support
requests.

INDIA REQUIRES MORE NEW DEVICES TO BE REGISTERED UNDER NEW MEDICAL DEVICE RULES, 2017

India’s Central Drugs Standards Control Organization (CDSCO) has officially added eight more medical devices to the list requiring registration. The new additions are:

(1) X-ray machines,
(2) CT scan equipment,
(3) MRI equipment,
(4) PET equipment,
(5) defibrillators,
(6) dialysis machines,
(7) bone marrow cell separators,
(8) all implantable medical devices.

Manufacturers and Importers of products under these categories need to immediately apply for import licenses in Form MD-14 of the Medical Device Rules, 2017. Products without valid registrations may not be imported and marketed after April 1, 2020.

The mandate was published in the Gazette of India on February 8th, 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 this list of devices was originally raised 10 months earlier at the May 16th, 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.