Before the release of the Medical Device Act, the regulations related to medical devices were placed within the genre of medicines under the Pharmaceutical Affairs Act. However, as technology develops, medicines and medical devices have less and less in common. As a result, making it increasingly difficult to assess and evaluate the two very distinguished categories of products by using the same standards. Therefore, to ensure that medical devices receive standard-compliant inspections, TFDA is now planning to launch the “Regulations Governing Delegation or Commission of Medical Device Testing” in order to replace the current “Pharmaceutical Affairs Act: Article 104-3”. The key takeaways of this new regulation for medical devices are listed below.

“Pharmaceutical Affairs Act”

Draft of “Regulations Governing Delegation or Commission of Medical Devices Test”

Article 104-3

1. General provisions

When necessary, a competent health authority at any level may designate a third party contractor or commission a relevant agency (or organization) to conduct all or part of the test checks and inspections.

The regulations governing such designation or commissioning and related matters shall be prescribed by the central competent health authority.

2. Authorization of designating a subordinate agency or commission a relevant agency

When necessary, a competent health authority at any level may designate a third party contractor or commission a relevant agency (or organization) to conduct all or part of the medical device’s inspections. The regulations governing such designation or commissioning and related matters shall be prescribed by the central competent health authority.

3. Requirements of third party contractors and relevant agencies

Third party contractors and relevant agencies should fulfill below requirements:

(i) According to different test items, third party contractors and relevant agencies should have the corresponding inspection ability, site, facility, and equipment.

(ii) Inspection operating procedure and quality assurance plan should be established.

Article 104-3

4. Requirements of commission contract

When necessary, a competent health authority at any level may designate a third party contractor or commission a relevant agency (or organization) to conduct all or part of the test checks and inspections.

The regulations governing such designation or commissioning and related matters shall be prescribed by the central competent health authority.

The content should include:

(i) Commission items

(ii) Commission period

(iii) The rights and system for the competent health authority to supervise and audit

(iv) Third party contractors and relevant agencies should undertake confidentiality obligations and liabilities to all personal information and trade secrets

(v) The condition to terminate and rescind the contract

(vi) The responsibilities of the third party contractors and relevant agencies after the termination and rescission of the contract

(vii) The handling of disputes in the contract

(viii) Other rights and obligations

5. Reception of test articles and obligations after the completion of the test

5.1

While receiving test articles, third party contractors and relevant agencies should issue an invoice and take the responsibility of specimen storage.

5.2

Inspection reports in written form should be given out after the experiment completion. When necessary, electronic reports may be sent in advance upon the competent health authorities’ request.

6. Requirements of inspection report

Inspection reports should include the following items:

(i) Report number or other identifiable information

(ii) The name, address, contact number, and other information of the third party contractor or relevant agency

(iii) The name, address, and the entrusted inspection order number of the competent health authority

(iv) The appearance or physical description of the medical device test article, along with photos, product name or code, receiving date, testing date, method, result, and the assigned test items

(v) The brand, model, serial number or lot number, manufacturer, certification number, date of manufacture, effective period, expiration date, or other information of the medical device test article

(vi) The date when the inspection report was conducted with the signature or seal of the person in charge

Article 104-3

7. Regulations related to the involvement of additional institutions

When necessary, a competent health authority at any level may designate a third party contractor or commission a relevant agency (or organization) to conduct all or part of the test checks and inspections. The regulations governing such designation or commissioning and related matters shall be prescribed by the central competent health authority.

Upon agreement from the competent health authority, third party contractors may appoint other institutes to conduct technical trials. Test reports issued by these other institutes should be stated clearly in the inspection report with report number or other trackable information.

8. Confidentiality obligations of third party contractors and other relevant agencies

Third party contractors and relevant agencies should undertake confidentiality obligations to the content of commission and test results, all related information must not be disclosed without authorization.

9. This regulation shall be effective from its implementation date

TFDA is now open for comments and suggestions for the draft regulation, discussion can be joined via the below reference link or email MINISTRY OF HEALTH AND WELFARE at [email protected] before 2020/09/07.

References:
預告訂定「醫療器材檢驗委任或委託作業辦法」草案
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