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.

THAI FDA PLANS TO CHARGE FEES FOR EXPERT REVIEW IN MEDICAL DEVICE REGISTRATIONS PROCESS

The Thai FDA is preparing to charge a fee for the Expert Review procedure of the Import License application process.  Currently there is no additional fee for the Expert Review that is applied to the registration process for high and medium risk devices and certain low risk devices.

The application of the new fee is to correspond with adoption of a new device classification system based on ASEAN Medical Devices Directive guidelines.  Then the Expert Review fees would vary by device classification, as below:

  • Class 1 – THB 0 or THB 25,000 (US$740)
  • Class 2 – THB 38,000 (US$1,120)
  • Class 3 –  THB 63,000 (US$1,850)
  • Class 4 – THB 88,000 (US$2,590)

Implemented is expected to begin as early as August.

 

Thailand FDA Publishes New Guidance on Post-Market Vigilance

The Thai FDA has published a Notification clarifying post-market vigilance requirements referenced in sections 5 (1) and 41 (5) of the Medical Device Act B.E. 2551 (2008). The requirements are to go into effect in this November and are considered an important step toward harmonization of the Thai regulations with the ASEAN Medical Device Directive.

The Notification outlines criteria and reporting timelines for device defects or adverse events and field safety corrective actions. In summary, the initial report for adverse events must be submitted within 48 hours, 10 days or 30 days depending on severity with a follow up report 30 days later. This is in line with Singapore and other SE Asian regulations.

Field Safety Corrective Actions must be reported within 48 hours of implementation with a follow up report 21 days later. Significantly, actions that occur within Thailand, as well as globally, must be reported.

Further steps toward harmonization with AMDD are expected in early 2017.

Thailand to Implement New Medical Device Classification System

The Thai FDA has announced its intentions to implement a risked-based medical and IVD device classification system toward harmonization with ASEAN MDD guidelines.  The new four-tiered system is to take effect in September of 2016 and will replace the current classification system.  At that time, Class D, C, and B devices will require CDST files in support of their product registration applications. The change will represent an increased regulatory burden for all but Class A devices.

4 Product Development Decisions that Impact Sales Performance in Asia

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US medical device manufacturers typically launch new products in Asia only after establishing success in the US and Europe. However, decisions made in the product development process have significant impact on regulatory costs, time to market and ultimately sales results in Asia. Address these four points to ensure fastest time-to-revenue in Asian markets.

Incorporate Asian Requirements into Product Testing
Conformance testing certificates are a common element of medical device registration applications. In most Asian regulatory systems, test reports used for US and European device registration are sufficient, with notable exceptions. South Korea and other markets require CB Scheme certification for electrical safety testing certificates. Further, testing records should be generated based on a country’s electrical supply (e.g., 220V/60Hz and/or 380V/60Hz). In Indonesia, Certificates of Analysis require numeric test values as well as a pass/fail designation. In China, in addition to having a complete set of test certificates to international standards, registration of Class II and III devices will require test certificates generated from one of ten local CFDA-certified test laboratories.

Design Your Clinical Trial to include Asian Requirements
If you must conduct a clinical trial in support of FDA Approval or CE Marking, confirm the data generated will also be acceptable for device registration in Asia. The Pharmaceutical and Medical Devices Agency in Japan offers a Clinical Trial Consultation just for this purpose. You may also consider the Harmonization by Doing program in Japan, which is designed to reduce the cost and time to register novel devices significantly by shifting 25% of your patient sample from a US clinical trial to Japan. The CSCSO in India will generally accept clinical data from outside India (except for drug-eluting stents, etc.), but may want to see ethnicity data. Again, Chinese registration of Class II and III devices will require a limited local clinical trial data.

Select a Fully Recognized Notified Body
Pick an ISO 13485 Registrar and CE Mark Notified Body that is recognized by competent authorities in Asia to avoid redundant QMS inspections and product conformity assessment fees. The Australian government has a mutual recognition treaty with the European Union whereby medical devices with CE Mark avoid local conformity assessment, greatly accelerating market listing in Australia. However, the Australian government has begun to deny recognition of certain Notified Bodies. In Japan, if your device qualifies for Pre-Market Certification (most Class II and some Class III devices), conformity assessment will be performed by a private Registered Certification Body. Seven of the fourteen RCBs also provide CE Mark in Europe. In Korea, a similar situation applies to most Class II devices. In Malaysia’s new and evolving regulatory system, all devices must undergo local conformity assessment, though the assessment for devices with reference country approval is greatly expedited. In these cases, manufacturers may request synergies if their Notified Body is also their RCB in Japan or Third Party Reviewer in Malaysia and South Korea.

Budget to Control Your Registration Certificate in Asia
In the US, Europe and Canada, the manufacturer on the labeling is considered the owner of the product registration certificate. In all other regulatory systems, the license/certificate/listing is owned or fully controlled by a local agent. In these markets, foreign manufacturers can only change or add distributors with the cooperation of the incumbent license holder. If the license is held by a commercial distribution partner, it is difficult to add, change or influence distributors in that market. Also, start-up companies with acquisition strategies have added incentive to control registration certificates to enhance acquisition value and enable the acquiring company to integrate new device/s into its direct sales channel. This situation can only be assured through an independent license holder.

Consult with Asia Actual for specific conditions that apply to your devices in Asia.

Medical Device Sales in Asia

29 countries in the Asia Pacific sales region do not have a national medical device regulatory review system.

Asia Pacific Sales Region – Medical Device Registration Systems:
44 countries
3.74B people
$31B device market
29 countries without regulatory review systems
15 countries with regulatory systems
9 countries with reference country approval requirements
Note: hospital purchasing managers in these countries may require products to have home or reference country approval.