Since 2016, subcutaneous fillers under TFDA classification “I.0007 Hyaluronic Acid Implants” are required to follow Regulations for Drug Safety Monitoring and establish a Periodic Safety Update Report (PSUR) protocol. It allows TFDA to monitor the safety of the medical devices sold domestically and abroad. TFDA thus have sufficient surveillance reports and clinical evidence to support and re-evaluate the overall product safety, efficacy, and risk.

Upon monitoring these medical devices for several years, products under I.0007 have been reconsidered to be withdrawn from conducting PSUR on a regular basis. Therefore, starting on July 23rd, 2020, TFDA decided to cease the previous regulation: “Products under classification I.0007 Hyaluronic Acid Implants required to conduct PSUR”. Instead, the product will be evaluated case-individually, through verifying their characteristic and clinical data, whether PSUR is necessary. Products which already engaged in safety monitoring program are still required to follow the schedule strictly and complete the scheme.

Below extracts the TFDA guidance on I.0007 Hyaluronic Acid Implants, brought to you by Qualtech.

“I.0007 Hyaluronic Acid Implants” is classified as a high risk (class 3) product that covers medical devices with hyaluronic acid substances used to modify or filled into surface defects on the face or other body positions. As it is a class 3 medical device, to register HA implants in Taiwan, clinical trials with required observation period are required. If manufacturers would like to apply comparing substantial equivalence, physio- and chemical tests shall be carried out to confirm the equivalence between the products.

Requirements for submitting I.0007 Hyaluronic Acid Implants are summarized.

Product description and specification:

The instruction for use in traditional-Chinese are recommended to include the following items:

1.  Product name and model numbers

3. Device description

4. Type of sterilization

5. Indications for Use

6. Contraindications

7. Warnings

8. Precautions

9. Instruction for use

10. Adverse Events

11. Specification of the injection needle

12. Storage conditions

13. Expiration date

14. Name and address of the manufacturer

15. Name and address of the pharmacist

Technical documents are recommended to include the following items:

1. Raw material related documents

2. Specification, functionality, indication of the product

3. Technical documents of syringes

4. Technical documents of needles (if applicable)

5. Drug substance

6. Technical documents of the manufacturing process

Pre-clinical safety and performance data:

1. Biocompatibility test

2. Sterility

3. Pyrogen

4. Chemical properties

5. Physical properties

6. Performance test

7. Analysis of active ingredient in final product

8. Animal studies

9. Pharmacology and toxicity for drug substance

10. Tolerances and suitability for human use

11. Pharmacokinetic and pharmacodynamic for drug substance

12. Drug release kinetic information

13. Packaging

14. Shelf-life

Academic papers, research reports and documents related to the product:

1. Clinical evaluation report to support product safety and efficacy

2. Evaluation report focusing on the risk of cross-linking agent on causing cancer

3. Literature reviews with medical devices that are substantial equivalent to the product

Clinical trial:

1. Clinical research reports or published journal articles which provide sufficient evidence of the safety and efficacy of the claimed indications of the applicating product

2. Post-market surveillance reports


1.  TFDA Announcement: Cease to comply with the regulation regarding “Products under classification I.0007 Hyaluronic Acid Implants required to conduct PSUR”

2.  Regulation for Drug Safety Monitoring

Guidance for Hyaluronic Acid Dermal Implant with Drug