COVID-19 impacts medical device shipment logistics. Manufacturers will need to adapt their supply chain in order to meet demands and lower costs.
Asia Actual assists IceCure in achieving goals for continued expansion in Asia
The Thai government has voiced their commitment to ending the epidemic by supporting preventative awareness, access to cost-effective tests and treatment resources through public investment and/or private partnerships.
In the wake of the COVID-19 outbreak, the Thai FDA announced on March 5, 2020 that they will cancel their plans to begin regulating alcohol gel sanitizers as medical devices.
Hong Kong’s Department of Health officially changed the name of the Medical Device Control Office (MDCO) to the Medical Device Division (MDD) at the end of 2019.
Learn about the significant opportunities and challenges medical device companies can expect when accessing this dynamic and thriving market.
With Regulation B.E. 2562 (revision from regulation B.E. 2540), the Thai FDA increased the regulatory status of breast implants from Notified to Licensed (Class 4)
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.
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.
- Australia: Therapeutic Good Administration (TGA)
- Canada: Health Canada (HC)
- European Union: Notified Body (EU NB)
- Japan: Japan Ministry of Health, Labour and Welfare (MHLW)
- 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:
- Market Approval from regulatory authority in reference countries
- Marketing History Declaration
- 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
- 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.
- Letter of Certification conformity to Concise Evaluation
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.
- 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.
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 1||THB 25,000 (US$740)|
|Class 2||THB 38,000 (US$1,120)|
|Class 3||THB 63,000 (US$1850)|
|Class 4||THB 88,000 (US$2,590)|
CLASS I “LICENSED” MEDICAL DEVICES
1 YEAR PROCESSING TIME
- Gloves, surgical and exam
- 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