Making changes to the registration dossier
Adhering to the regulations in Government Resolution No. 1416, we specialize in updating manufacturer information, including legal entity changes, name alterations, and address modifications. This ensures that all registered details accurately reflect the current status of the medical device manufacturer, maintaining compliance with state registration rules.
Guiding Registration Dossier Amendments
Modifying the Registration Certificate
The amendment process for registration documents follows paragraph 55 of the Russian Federation’s Government Decree No. 1416, dated December 27, 2012, endorsing the Medical Devices State Registration Rules.
When changes are needed (as requested by the applicant) to documents referred to in subparagraph “a” of paragraph 54, the applicant must submit a change request along with supporting documents to the registration authority.
If changes to documents outlined in Rule 10 sub-paragraphs are required:
- “c” the manufacturer’s technical documentation for the medical device,
- “d” the manufacturer’s operational documentation, including the user manual or operating instructions for the medical device,
- these changes are subject to an evaluative process similar to that used for the medical device’s state registration quality, efficacy, and safety assessment, in line with paragraph 21 of the Rules.
Changes are permissible only if they do not alter the properties and characteristics affecting the medical device’s quality, efficacy, and safety, or if they enhance these properties without changing the device’s functional purpose or operating principle.
Should the revisions to the technical and/or operational documentation pertain to:
- extending or removing the expiry date of the technical specifications for the medical device,
- altering the labeling or packaging of the medical device,
- updating information about the authorized representative of the medical device’s manufacturer,
- refreshing documents in the registration Certificate (like ISO certificates, and manufacturer’s authorizations),
The Roszdravnadzor has the authority to approve these amendments independently, without the aforementioned assessment.
Documents needed for changes due to the technical conditions, authorizations (contracts), and certificates (such as ISO 13485, 9001) expiring:
- A statement on the introduction of amendments to documents as provided for in paragraph 10 of the Rules.
- Updated documents (for example, specifications and notification of changes to specifications)
- In the case of a foreign manufacturer – a power of attorney for the authorized representative of the manufacturer.
Documents Required for Revisions in Response to Updates in Regulatory Documents or National (International) Standards that Govern the Manufacturing and Utilization of the Medical Device:
- A statement regarding the revision of documents as stipulated in Section 10 of the Policies.
- The manufacturer’s technical and operational documentation, citing the updated documents that govern the production and use of the medical device (such as technical specifications and notices of technical specification amendments, identification documents, user manuals, etc.)
- For foreign manufacturers – a power of attorney to the manufacturer’s designated representative
- Protocols of required tests that verify the implemented changes and are in accordance with the Russian Ministry of Health’s Order No. 2n dated January 9, 2014.
Required Documentation for Modifications Due to Changes in the Labeling or Packaging of a Medical Device:
- A statement on the amendments to the documents as stipulated in paragraph 10 of the Rules.
- All documents containing information about the labeling or packaging of a medical device (for example, technical specifications and notification of changes to technical specifications)
- Photographic images of the labeling layout
- In the case of a foreign manufacturer – a power of attorney for the authorized representative of the manufacturer
- Documents confirming the rights to use an additional service mark
Documents Required for Updates Following Changes in Storage Duration, Expiration Dates, or Manufacturer’s Warranty Periods, as well as Changes in Information Regarding Maintenance, Repair, Disposal, or Destruction of the Medical Device:
- A statement on the introduction of changes in documents, as envisaged by paragraph 10 of the Rules.
- Documents containing information on new storage terms, shelf life, or terms of manufacturer’s warranty obligations, as well as details on the new procedure for technical maintenance, repair, disposal, or destruction of a medical device (for example, technical specifications and notification of changes to technical specifications, passport, or operating manual, etc.)
- Protocols of necessary tests, confirming the changes made and in accordance with the order of the Ministry of Health of Russia dated 09.01.2014 No. 2n
- In the case of a foreign manufacturer – a power of attorney for the manufacturer’s authorized representative
Documentation Required for Revisions Due to Changes in the Indications (Contraindications) for Use of the Medical Device or Changes in the Device’s Scope of Application:
- A statement detailing the amendments to the documents specified in Section 10 of the Regulations.
- A document containing information on new indications (contraindications) for the use of a medical device or the scope of application of a medical device, based on which the manufacturer has made the corresponding decision (for example, results of clinical studies)
- In the case of a foreign manufacturer – a power of attorney for the manufacturer’s authorized representative
Documents Required for Updates Following Changes in Storage Duration, Expiration Dates, or Manufacturer’s Warranty Periods, as well as Changes in Information Regarding Maintenance, Repair, Disposal, or Destruction of the Medical Device:
- A statement regarding the update of documents outlined in Section 10 of the Guidelines.
- Documentation that includes information on the medical device’s new features (technical and operational documents).
- Test protocols that validate the changes made, complying with the Russian Ministry of Health’s Order No. 2n dated January 9, 2014.
- In the case of a foreign manufacturer – a power of attorney for the manufacturer’s authorized representative
Possible Changes Requiring Updates to Technical and Operational Documentation:
Modification of the Product Name
- Details affirming the unchanged functional purpose
- Consistency or enhancement of properties and characteristics that impact the medical device’s quality, efficiency, and safety
Modification of Parameters and Characteristics
- Confirmation of unchanged functional purpose
- Details on all modified parameters and characteristics
- Methods for validation of new parameters and characteristics
Modification of Sterilization Techniques
- Documentation for sterilization process validation
- Markings on medical devices provided in a sterile condition
Modification of Reliability Features
- Data on shelf life and storage timeframes
- Service life information
- Warranty term specifics
Modification of Additional Information on the Medical Device
- Procedures for disposal
- Logistics and storage information
Renewal of Time-Sensitive Documents
- Technical documents and quality management system certifications
- Other time-sensitive documents
Basis for Conducting Clinical Trials According to Paragraph 55 of the Rules for the State Registration of Medical Devices:
- Broadening of Usage Indications
- Refinement/Supplementation of Usage Indications
- Clarification/Expansion of Usage Contraindications
- Clarification/Expansion of Adverse Effects Upon Usage
- Widening the Scope of Application
- Modernization of Operational Modes
- Inclusion of Additional Operating Components and Modes
- Broadening the Conditions for Use
- Compatibility of Medical Devices
- Revisions to Special Directions for Medical Device Usage
We provide comprehensive project management at every stage of its review, offering professional assistance in dossier preparation, addressing remarks, and preparing well-founded responses to expert service inquiries.
Please send us your request; our registration specialists will analyze your existing data, identify the optimal registration process, assess the scope of work needed for dossier preparation, and provide you with a commercial offer for dossier preparation services.
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