THAI FDA ADDS ‘CONCISE EVALUATION’ FOR QUALIFYING MEDICAL AND IVD DEVICES

The Thai FDA has amended the Medical Device Act, 2009, and Medical Device Ordinance, 2018 (as amended) to add a Concise Evaluation option for qualifying Notified and Licensed medical and IVD devices. The new evaluation process eliminates the requirement for a Fee Sales Certificate / Certificate to Foreign Government issued from the country of origin. Guidance was published on September 30, 2019 with immediate effect. 

QUALIFICATION

To qualify for Concise Evaluation, a medical device must be registered (through full evaluation) and marketed for more than one year without any serious adverse events in 2 of 5 reference markets listed below; or in 1 of the markets for at least three years.

  1. Australia: Therapeutic Good Administration (TGA)
  2. Canada: Health Canada (HC)
  3. European Union:  Notified Body (EU NB)
  4. Japan: Japan Ministry of Health, Labour and Welfare (MHLW)
  5. USA: Food and Drug Administration (FDA)
NEW DOCUMENT LIST

In addition to the same documents required for a Full Evaluation, the following additional documents are required for the Concise Evaluation:

  1. Market Approval from regulatory authority in reference countries
  2. Marketing History Declaration
  3. Manufacturer Safety Declaration to confirm no reported deaths, serious deterioration in the state of health, open field safety corrective actions (recalls) at the point of submission of the application
  4. Declaration Letter that Device Quality; intended use, indication packaging, labeling, instructions for use for supply in Thailand are identical as that approved by the reference agency.
  5. Letter of Certification conformity to Concise Evaluation

For IVD devices, the products must also be included on the World Health Organization’s (WHO) list of pre-qualified IVD products (list available here).

Asia Actual has a strong regulatory team in Bangkok to help device manufacturers stay informed and compliant with regulatory changes. Please contact us with questions or support requests.

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.

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 (Class 4). 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.

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

1 YEAR PROCESSING TIME

  • Condoms
  • Gloves, surgical and exam
  • Syringes
  • HIV test kits
  • Contact lens (corrective and cosmetic)
  • Injective Hyaluronic for defective skin (09/13/2019)

CLASS II “NOTIFIED” MEDICAL DEVICES 

6-8 MONTHS PROCESSING TIME

  • Physical therapy equipment
  • Alcohol detectors
  • Methamphetamine Detectors
  • Breast implants
  • Opthalmic Viscoelastic Device
  • Concentrate for haemodialysis (10/03/2017)
  • Alcohol based sterilizer (09/13/2019)
  • Alcohol gel sanitizer (09/13/2019)
  • Teeth whitening devices (Hydrogen peroxide 6% +, fluorite 0.11% +) (09/25/2018)
  • Intense Pulsed Light (IPL) devices (pending)
  • Automatic External Defibrillators (AED) (pending)
  • Syphilis Screening Tests (pending)

CLASS III “GENERAL” MEDICAL DEVICE

2 TO 6 DAYS PROCESSING TIME (TYPICAL)

  • All other medical devices
  • Including dental equipment

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

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.

NEW OFFICE SPACE FOR ASIA ACTUAL THAILAND

Asia Actual is excited to announce the dedication of our new office space in the Bangkok. Mr. Binh Thai, General Manager at Asia Actual Thailand, commented, “We have sought to establish a comfortable, modern space to provide a safe and productive environment for our employees and visiting clients.” The investment reflects the company’s commitment to the Thai market and expectations for growth in demand for high quality regulatory, importing and commercial support from multinational medical device manufacturers.  Come visist us soon at:

No. 173, Asia Centre Building, South Sathorn Road

Thung Maha Mek Sub-District, Sathorn District

Bangkok 10 10120  Thailand

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.