Tips for Importing Medical Devices into Thailand

Importing medical devices into Thailand is more difficult than in other countries in the region. It is important to work with an importer with staff experienced with medical device imports to avoid customs clearance delays and added costs.

Unique to the customs clearance process for medical devices in Thailand is the requirement for a License Per Invoice (LPI) approved by the Thai FDA for each shipment. The Import License holder must apply with credentials, the original Import License, and original shipping documents (e.g., Air Waybill, shipping invoice and packing list) submitted online to Thai FDA. (The one-time fee to the TFDA for LPI submission which includes the Stamp Duty, Power of Attorney, and document submission). The FDA will confirm that all devices included in the shipment (by part number) are covered by a valid import license and then issue the LPI.  The application review process take 1 to 2 days.  The resulting License Per Invoice document is a required element of the customs clearance process for registered medical devices, accessories and spare parts.

The overall process is then similar as in other countries with assemble a submission of shipping documents, payment of import tax (if any depending on HS code), payment of VAT (7% on all goods and services), etc.  Shipping rate will vary significantly by mode and point of origin; and should be known to manufacturers.  Customs Clearance charges should not exceed 1% of Cost of Goods.

A source of common delays can be:

  1. discrepancies or inconsistency with HS Code (when using different Freight Forwarders)
  2. inconsistency between shipments with the value of goods
  3. delayed LPI application filing
  4. Shipments containing expired and valid items as Customs does not allow for partial clearance.
  5. Shipments containing parts from different manufacturers.

Ms. Pratabjai (Ann) Panuchaklap is responsible for managing the importation process at Asia Actual.  She has been managing supply chain logistics in Thailand for more than 20 years with a specialization in medical devices and pharmaceuticals.

Using Asia Actual as your License Holder in Thailand comes with the added benefit of expertly managed, efficient and transparent importations.

Contact us for more information on our importing servcies.

Indonesia Medical Device e-Catalogue Enrollment: 2018 Debrief

Access to the public hospital on-line procurement system, e-Catalogue, is an important part of a successful sales strategy in Indonesia for most medical and diagnostic devices. At the same time, navigation of the enrollment process is a challenge for many manufacturers and distributors. To be positioned for successful e-Catalogue listings, it is important to understand the submission process and to anticipate expected changes for 2019.

The e-Catalogue system in Indonesia is managed by the LKPP (The Government Agency for Procurement of Goods & Services).

Application Deadlines

On March 26th the LKPP released the enrollment schedule for 2018 with the deadline for application submission set at April 20th. Applicants had just 20 working days to prepare. Successful applicants were notified on April 30th.  Price negotiation meetings were to be completed by May 4th, but due to high application volumes the deadline has been extended through December 2018. This was a much-accelerated schedule compared to previous years.

Eligible Products List

At the same time three, separate lists were published identifying 613 categories of eligible devices. Enrollment eligibility has varied over the years from first-in-first-out open enrollment from 2014 to 2016; to periodic by-invitation-only from 2016 to 2017; to the current mass enrollment one-time per year established in 2018.

Required Documents

The list of documents required for the e-Catalogue application for medical devices has changed several times making advanced preparation difficult. (The latest version is the LKPP 5th schedule published on June 7, 2018.) Verification of application documentation is very strict, and many applications have been rejected for non-compliance. Particularly challenging is getting authentication of the Distributor Appointment Letter (Surat Tanda Pendaftaran, or STP) by the Ministry of Trade at the Indonesia Consulate in country of origin due to processing time requirements.

Pricing

Price negotiations seem to be restricted to between 20% and 40% of the Landed Cost of a device (inclusive of CIF charges). The range depends on effective justification of the support effort and costs. Sufficient time should be budgeted for e-Catalogue pricing strategy consideration and negotiations preparation.

2019 Enrollment

In 2019 significant changes are expected for e-Catalogue enrollment for medical and diagnostic devices with management being shifted from the LKPP to the Ministry of Health. The next intake is expected in July 2019 with what may be open enrollment for all product categories. Distributor markup is anticipated to be fixed at 1.4 times Landed Cost.

Manufacturers should begin now to register devices of interest for e-Catalogue listing choosing their local Indonesia Agent carefully. It is important to prepare applications early according to current requirements and stay vigilant any additional changes.

Asia Actual‘s experienced staff in Jakarta is available to respond to questions and support requests.

India to Regulate Glucometers, Blood Pressure Monitors, Nebulizers and Digital Thermometers

At the July 25th Drugs Technical Advisory Board (DTAB) meeting, a resolution passed to add (1) glucometers, (2) blood pressure monitoring devices, (3) nebulizers, and (4) digital thermometers 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.

This is the third Notification announcement since the Medical Device Rules, 2017 were enacted on January 1st of this year. The decisions are coming with increased frequency, so manufacturers of non-Notified devices are advised to stay alert for announcements and make early registration preparations.

Asia Actual has a strong regulatory team in Delhi to help companies stay informed and ahead of regulatory changes.

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.

Indonesia Tightens Enforcement of Medical Device Licensing

With the implementation of Regulation No. 60, 2017 on February 1st, 2018 the Indonesia government tightened enforcement of medical device licensing requirements.

Formerly, compliance for imported medical devices was confirmed during the customs clearance process by Customs and Excise Department officials. Now the Ministry of Health is authorized to extend confirmation through inspection at medical device distributors (AKA, Post-Border monitoring).

Any devices without proper licensing may result in re-exportation or destruction at the importers expense. Further, distributors in possession of improperly licensed devices may have their Distribution License suspended.  The move is expected to increase compliance with the medical device registration requirements.

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

Russia Streamlines Medical and IVD Device Regulations

On the May 31st Russian Federal Service for Surveillance in Healthcare (Roszdravnadzor) published Decree No. 633 which includes provisions that significantly improve the registration process for medical and IVD devices. The changes go into full effect on June 13th, 2018.

Main points from Decree No. 633 impact:

  1. Combination Device Registrations

Medical devices which contain pharmaceuticals (e.g., bone materials, drug eluting stents, dermal fillers, glues, etc.) can now be registered in Russia if the pharmaceuticals component is registered in its country of origin.  Since March of 2017, such devices could only be registered in Russia if the pharmaceutical component was registered in Russia.

  1. IVD Device Registrations

The requirement to obtain permission from Roszdravnadzor to conduct clinical trials in Russia as part of the registration process has been removed.  By eliminating the required permission, the manufacturers may move directly to conducting trails whereby saving 2 to 3 months in the registration process for Class 2a, 2b, 3 IVD devices. The updated procedure now includes Technical File and IFU development to Russian standards, technical and EMC testing (if required), clinical trials arrangement; and application submission to Roszdravnadzor.

  1. License Amendments

Decree No. 633 clarifies the requirements and procedures to amend current registration certificates. Previously without clear guidance changes to a certificate may have resulted in the need for re-registration.  Now changes such as adding/deleting new models, or accessories, changing the Authorized Representative, labeling changes, etc. are available according to the law and in accordance with EAEU guidelines.

The decree amends the Rules of State Registration of Medical Devices № 1416 which were approved by the Government of the Russian Federation on December 27, 2012.

Asia Actual has a strong regulatory team in Moscow to provide efficient, transparent management of device registrations, post market vigilance and Authorized Representative services.

Please contact either of us with questions or service requests.

 

India to Regulate More Medical Devices

At the May 16th Drugs Technical Advisory Board (DTAB) meeting, a resolution passed that expands the list of notified medical devices requiring registration with the Central Drugs Standards Control Organization (CDSCO) in India. The following device categories are affected:

  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

Next the Ministry of Health and Family Welfare must issue a Gazette Notification for the requirement to become official. It is expected to take 5 months from DTAB board resolution to Notification with a 6-month grace period for compliance. Important guidance on specific devices to be included as well as classification confirmation are not yet available. Manufacturers of these devices should take urgent action to prepare registration applications.

This is the second Notification announcement since the Medical Device Rules, 2017 were enacted on January 1st of this year. From the early pattern it appears that new devices will be added at each quarterly DTAB meeting. The next is scheduled for mid-August. Manufacturers of non-Notified devices should stay alert for future announcements and make early plans to maintain continued access to the Indian market.

Asia Actual has a strong regulatory team in Delhi to help companies stay informed and ahead of regulatory changes.

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.

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.

Indonesia the Next to Takes Steps Toward ASEAN MDD Harmonization

On January 13, 2018 the Indonesia Ministry of Health implemented Permenkes No. 62, 2017, Marketing Authorization of Medical Devices, IVD Devices and Household Goods. This is the first major overhaul of medical device regulations in seven year (replacing Permenkes No. 1190, 2010) with the intent to improve efficiency, harmonize with ASEAN MDD standards, and align with updates to Indonesian legal and import regulations.

Important provisions include: 

  1. device definitions harmonized with ASEAN MDD
  2. device classification harmonized with ASEAN MDD
  3. technical data formatting harmonized with ASEAN MDD (CDST)
  4. application review times for medical device registration cut in half (15 days for Class A, 30 days for Class B and C and 45 days for Class D) for import goods
  5. implementation of E-reporting systems for distribution records and complaint handling through E-Watch systems
  6. clear requirements for post market vigilance

Implementation of the new Rules has been rather smooth with new faster review timelines largely being met. Indonesia is the third country to implement the ASEAN MDD standards after Singapore and Malaysia, with the Philippines announcing plans for implementation in early 2019.

Asia Actual Expands into Russia

Asia Actual is excited to announce the extension of regulatory and commercial services to support client operations in Russia.

Medical device manufacturers must appoint, and grant Power-of-Attorney to a local, registered company in Russia to submit registration applications and act as Authorized Representative (AR). The Russia AR will be listed on the local labeling and be responsible for post market vigilance reporting.

Appointing a reliable, professional Authorized Representative is critical to a successful business strategy in Russia.

Please contact us or visit our updated website for more information.