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THAILAND ELEVATES REGULATORY STATUS OF DERMAL FILLERS

With Special Announcement No. 136 the Thai FDA increased the regulatory status of Hyaluronic Acid-based dermal fillers from Notified to Licensed. This change will effectively increase the cost and time required to obtain an Import License for these devices under the current regulations.

This change was announced on September 13, 2019 and goes into effect 180 days later (on March 11, 2020). Products covered by an existing Import License will retain market access until expiry. All new or renewal applications are subject to the new requirements.

The requirements apply to devices intended for sterilization of human or animal skin or medical formulated from ethyl alcohol or ethanol (minimum of 70% by volume). Government processing fees will depend on device classification as per the table below. Processing times are targeted at 6 months.

GOVERNMENT PROCESSING FEES
Class 1THB 25,000 (US$740)
Class 2THB 38,000 (US$1,120)
Class 3THB 63,000 (US$1850)
Class 4THB 88,000 (US$2,590)


CLASS I “LICENSED” MEDICAL DEVICES – 8-12 MONTHS PROCESSING TIME
  • Condoms
  • Gloves (surgical & exam)
  • Syringes
  • HIV test kits
  • Contact lens (corrective & cosmetic)
  • HA dermal filler (added 3/11/20)
CLASS II “NOTIFIED” MEDICAL DEVICES – 6-8 MONTHS PROCESSING TIME
  • Physical therapy equipment
  • Alcohol detectors
  • Breast implants
  • HIV test kits (research)
  • Alcohol-based sterilants (added 9/13/19)
CLASS III “GENERAL” MEDICAL DEVICES – 2-6 WEEKS PROCESSING TIME
  • All other medical devices

Contact Asia Actual for more information regarding regulatory changes in Thailand

THAILAND NOTIFIES ALCOHOL-BASED STERILIZATION PRODUCTS

With Special Announcement No. 136 the Thai FDA increased the regulatory status of alcohol-based sterilization devices from General to Class 2 Notified. This change will effectively increase the cost and time required to obtain an Import License for these devices under the current regulations.

This change was announced on September 13, 2019 for immediate effect. Products covered by an existing Import License will retain market access until its expiry. All new or renewal applications are subject to the new requirements.

The requirements apply to devices intended for sterilization of human or animal skin or medical formulated from ethyl alcohol or ethanol (minimum of 70% by volume). Government processing fees will depend on device classification as per the table below. Processing times are targeted at 6 months.

Class 1THB 25,000 (US$740)
Class 2THB 38,000 (US$1,120)
Class 3THB 63,000 (US$1850)
Class 4THB 88,000 (US$2,590)

Contact Asia Actual for more information regarding regulatory changes in Thailand

4 PRODUCT DEVELOPMENT DECISIONS THAT IMPACT SALES PERFORMANCE IN ASIA

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 Central Drugs Standard Control Organization (CDSCO) 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.

Examples:
    • 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.

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