As Medical Device Act was published on 2020/01/15, it requested medical device manufacturers to establish quality management system. Therefore, TFDA is now planning to launch “Regulations Governing the Inspection of the Medical Device Quality Management System and the Issuance of the Manufacturing License” in replace of the current “Pharmaceutical Good Manufacturing Practice Regulations: Part 3 - Good Manufacturing Practices for Medical Devices”. Below is the table of comparison between the current “Specifications on Good Clinical Practice for Medical Devices” and the upcoming regulation:
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Current Version |
Draft Version |
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1. General provisions |
1. General provisions |
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1.1 Medical devices manufacturers must establish QMS with approval under the central competent authority (CCA) before manufacturing, except for items that do not need manufacturing license as announced. |
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2. Standard Mode |
2. Application for QMS |
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2.1 Please refer to table 1 for necessary documents for QMS application. |
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3. Essential Mode |
3. Application of QMS re-evaluation |
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3.1 For those failed QMS inspection, re-evaluation could be applied within 2 months since receiving written notice. This application could only be applied once. |
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4. Medical devices for use in clinical trials |
4. Inspection of QMS |
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4.1 CCA has the right to perform inspection regularly or irregularly. Irregularly inspection can be performed without noticing the manufacturer in advance. |
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5. Registered items on medical device manufacturing license and license content amendments |
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5.1 Registered items: (i) Name of manufacturer (ii) Address of manufacturer (iii) Approved scope and manufacturing descriptions (iv) For domestic manufacturer: Management representative (v) For foreign manufacturer: Local agency (vi) License number (vii) Effective period |
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5.2 For content amendments of (i), (ii), (iv), and (v), application should be submitted within 30 days when the change occurred. |
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5.3 For content amendments of (ii), this is only suitable for official address adjustments. In regards to changing manufacturing sites, a new application shall be submitted. |
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5.4 Please refer to table 2 for necessary documents for license content modification. |
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6. Application of medical device manufacturing license renewal |
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6.1 The effective period of the license is 3 years. License renewal should be submitted 6~12months before expiry. The new effective period is also 3 years. |
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7. Execution of QMS by CCA |
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7.1 While executing, inspectors must provide identification document and explain the purpose of the inspection. Moreover, the inspector has the right to adopt necessary measures to preserve evidences. |
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8. Sampling under QMS by CCA |
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8.1 CCA has the right to take random samples during inspection, manufacturer cannot designate the samples and the samples will not be paid. The taken items should be limited under efficient amount for inspecting. |
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9. Application for medical device manufacturing license |
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9.1 After onsite inspection, medical device agency could apply for manufacturing certification with a copy of medical device manufacturing license and a copy medical device agency license. |
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10. Revocation and nullification of medical device manufacturing license |
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10.1 CCA may revoke or nullify the license if (i) Medical device manufacturing license is revoked or nullified (ii) Medical device selling license is revoked or nullified (iii) Others |
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11. Return of medical device manufacturing license after revocation and nullification |
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11.1 Within 15 days after revocation or nullification of the license, if the certification in Article 9 is still valid, the document should be returned. Certifications that were returned would be revoked. |
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12. Application of closure and reopen of medical device agency |
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12.1 While applying for closure, if the certification in Article 9 is still valid, the document should be kept by district health authority and return to agency if reopen. |
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13. 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 nlopolymer@fda.gov.tw before 2020/08/17.
Table 1: Necessary Documents for QMS Application
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Domestic manufacturers |
Foreign manufacturers |
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Onsite inspection |
Document review6 |
Onsite inspection |
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Basic information of foreign manufacturer |
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O |
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Certificate of compliance equivalent to ISO 13485 |
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O |
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Certification of legal entity2 |
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O |
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Pharmaceutical manufacturing license |
O |
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Copy of factory registration certificate3 |
O |
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Letter of authorization4 |
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O |
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Quality manual |
O |
∆1 |
O |
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List of quality manual and procedures |
O |
O |
O |
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Quality manual and procedural documents |
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∆1 |
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Medical device file list5 |
O |
O |
O |
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Plant layout |
O |
O |
O |
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Production area |
O |
O |
O |
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List of manufacturing and inspection equipment |
O |
O |
O |
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Product manufacturing process |
O |
O |
O |
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Manufacturer organization chart |
O |
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O |
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Supplier of major raw material and components |
O |
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O |
Note:
1. Documents with ∆: While applying for QSD renew, only the updated part need to be provided along with a copy of the original QSD and an updated basic information of the manufacturer.
2. May be certification from local competent medical device authority, ISO 13485, or other documents that can show sufficient evidence of legal entity.
3. For those that are exempt from applying for factory registration under Factory Management Act or being approved by the central competent authority as manufacturer for research purpose can be exempt from this requirement .
4. Should state the foreign manufacturer authorizes domestic pharmaceutical agencies to apply for onsite inspection.
5. Medical device files are the files created under Medical Devices Act - Article 11 by the manufacturer.
6. Exempted documents for foreign countries under medical equipment technical cooperation exchanges, projects or other methods of equality and reciprocity, should follow the announcement of central competent authority.
Table 2: Necessary Documents for License Content Amendment
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Domestic manufacturer |
Foreign manufacturer |
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Name |
Address |
Management representative |
Name |
Address |
Local agency |
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Ownership transfer |
Name change |
Authorization transfer |
Name change |
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Copy of medical device manufacturing license |
O |
O |
O |
O |
O |
O |
O |
O |
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Copy of medical device marketing license |
O |
O |
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O |
O |
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Certification from household registration authority or other related authority |
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O |
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O |
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Certification of assign of management representative |
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O |
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Letter of amendment |
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O |
O |
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Certification issued by CCA in the country of origin regarding manufacturer name change (no change in address) or Free Sales Certificate (valid for 2 years) |
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O |
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Letter of assignment |
O |
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O |
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Letter of authorization |
O |
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O |
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Note:
1. Letter of authorization should be within one year since the signed date. It should also mention the transferring items, address of both original and new licensee, and the reason or purpose of transfer.
References: