Thailand NEW Medical Device Regulation

THAI FDA NEW REGULATIONS ON MEDICAL DEVICE CLASSIFICATION AND REGISTRATION

The new regulation is a risk-based classification system based on ASEAN MDD guidance. Formerly most medical devices fell under the General Medical Device category and were subject to a simple listing process. Only a handful of medical devices were subject to the more rigorous Notification and Licensing reviews. Now all Class 2, 3, and 4 device applications will require full technical data in Common Submission Dossier Template (CSDT) format with a grace period for some documents. Medical device Import License applications will need to be submitted via one of three routes (from low risk to high): Listings, Notifications, and Licenses. Certificates of Free Sale (CFS) will no longer be required as part of the registration process.

Previous classification	New classification	Date comes into force
General	Class 1 – Listing	Class 1: March 17, 2021
Notified	Class 2 – Notified Class 3 – Notified	Classes 2, 3 and 4: February 15, 2021
Licensed	Class 4 – Licensed

New medical device risk classification categories
There are now 4 (four) risk classification categories as opposed to 3 (three) previously and they apply to both IVD and non-IVD products.

Previously all relevant documentation for registration applications had to be submitted in one single submission. However, under the new rules there are two stages of submission to be followed:

Pre-submission – in this first stage applicants will need to input information in the pre-submission system to confirm the risk classification and medical device grouping if applicable. The turnaround time is 15 days from submission and is free of charge.

E-submission – once the risk classification and grouping have been confirmed, applicants may proceed to e-submission. This stage involves the partial or full submission of all relevant documentation for product registration and is subject to new turnaround times and fees.

New classification	Timeline
Class 1 – Listing	200 working days
Class 2 – Notified Class 3 – Notified	250 working days
Class 4 – Licensed	300 working days

THE PROS AND CONS OF THE NEW REGULATION:

PROS    

• The procedure is now standardized for all other ASEAN countries

• The duration of the licenses is no longer linked to the expiration of the Free Sale Certificate but is standard 5 years. (This particularly benefits Chinese manufacturers, who were penalized by the duration of their CFS, 2 years)

• The new regulation, being more stringent, guarantees greater quality and safety of the Devices placed on the Thai market.

CONS

• Higher costs and longer certification time

• More extensive and complex documentation

• License ownership remains non-transferable. (In case the manufacturer intends to change distributor, he will have to recertify the products.)

With the entry into force of the new regulation, the Entry Strategy suggested time ago by Kha Bangkok is even more valid:

The manufacturer has the possibility to choose between two different models:

OPTION 1:

Kha Bangkok provides Corporate Service opening Thai Company for Manufacturer. All TFDA Licenses will be under the new Thai Company name.

OPTION 2:

Kha Bangkok acts in Thailand like License Holder (Master Distributor). All TFDA Certificates will be under Kha Bangkok’s name.

Open Thai Company or appointing an in-country representative gives you real flexibility in your distribution strategy to nominate as many distributors and sales partners as possible. This means you can adapt quickly to changes in the market by adding new distributors, increasing transfer pricing as well as ensuring rigorous quality and compliance controls continue post-market.

For more information contact us   info@khabangkok.com