Designation Requirements for Hong Kong

Introduction

The governments of the United States and Hong Kong signed binding exchange letters to implement Phase I (for testing laboratories) and Phase II (for certification bodies) of the Asia Pacific Economic Cooperation Mutual Recognition Arrangement for the Conformity Assessment of Telecommunication Equipment (APEC Tel MRA)  on April 5, 2005. The Phase II provisions entered into force in 2008. 

The MRA between the US and Hong Kong covers the recognition of testing laboratories and acceptance of test reports generated by those recognized labs and the recognition of certification bodies and the acceptance of the product certification results issued by the recognized certification bodies.

Regulatory Authority

Hong Kong's regulatory authority is the Office of the Communications Authority (OFCA). 

A list of OFCA APEC Tel MRA Resources is located here.

Standards Available for Recognition
 

Please refer to Hong Kong’s ANNEX I to view the technical regulations covered under the MRA.

The HKCA specifications can be downloaded here.

The type acceptance criteria can be downloaded here.

Note:
Normally, OFCA does not accept any restrictions or limitations to the accreditation of the standards for which recognition is being sought.

Phase I: Testing Laboratories

CABs must meet the following requirements:

• General Requirements for CAB Designation
• OFCA MRA 002 Issue 5 - June 2022: Criteria and Requirements Applicable to Foreign Testing Laboratories and Certification Bodies Seeking Recognition by OFCA as Conformity Assessment Bodies.
• Special Notice for Radiation Protection Requirements if applicable (see further below)

The CAB shall submit the following documents to NIST electronically at mra [at] nist.gov (mra[at]nist[dot]gov).

• Phase I Application Documents  

Once NIST has reviewed the application and confirmed its completeness, NIST will forward a designation request to OFCA, who, under the terms of the MRA, has up to 60 days to respond to NIST.

Phase II: Certification Bodies

CABs must meet the following requirements:

• General Requirements for CAB Designation
• OFCA MRA 002 Issue 5 - June 2022: Criteria and Requirements Applicable to Foreign Testing Laboratories and Certification Bodies Seeking Recognition by OFCA as Conformity Assessment Bodies.
• Special Notice for Radiation Protection Requirements if applicable (see further below)

CABs must also review and become familiar with the following OFCA certification resources: 

OFCA Telecom Equipment Certification webpage
OFCA Database of Equipment Certified for Use in Hong Kong

Initial CB Application Documents & Process

The CAB shall submit the following Phase II documents to NIST electronically to mra [at] nist.gov (mra[at]nist[dot]gov).

• A cover letter or e-mail that includes:
  • A request to NIST for CAB designation to OFCA under Phase II of the APEC Tel MRA
  • Primary contact person’s name, mailing address, phone number including extension (if any), email
  • Alternate contact person’s name, mailing address, phone number including extension (if any), email
  • Desired OFCA Scope of Recognition for Phase II
• A copy of the ISO/IEC 17065 Accreditation Scope and Certificate (issued by a NIST-recognized CB Accreditation Body)
• A copy of the ISO/IEC 17025 Accreditation Certificate and Scope (issued by a NIST-listed Lab Accreditation Body)
  • The Scope of Accreditation for the ISO/IEC 17025 accredited lab combined with the Scopes of any subcontracted accredited testing labs must cover the full list of OFCA technical regulations (HKCA specifications and/or type acceptance criteria) for which Phase II recognition is being sought (OFCA MRA 002 – 5 c, d).
  • Subcontracted labs must be accredited by an accreditation body that is a signatory to the APAC MRA. (OFCA MRA 002 – 5 c)
• A copy of the CB's certification procedures
• A copy of the CB's auditing and surveillance procedures
  • Note:  Currently, OFCA does not require that recognized FCBs conduct post-market surveillance.  The requirement in item 7 of the OFCA MRA 004 checklist is not currently applicable for the OFCA scheme.
• A copy of the full ISO/IEC 17065 Assessment Report and Findings/Deficiency Report
• A copy of the completed OFCA Checklist (OFCA MRA 004 Issue 18, February 2024) for Technical Competence Assessment of Foreign Certification Bodies
  • (Note: The Technical Checklist for Technical Competence Assessment of Foreign\Certification Bodies will be used by the ISO/IEC 17065 Accreditation Body during the on-site assessment. Results of this assessment should be entered legibly in the checklist since NIST will send a copy of the checklist to OFCA.)
• A copy of contractual arrangements if part or all of the testing activities are subcontracted to other testing laboratories (that must be accredited to ISO/IEC 17025 by an accreditation body which is a signatory to the APAC MRA).
• A signed copy of the CAB Declaration Form

Once NIST has reviewed the application and confirmed its completeness, NIST will forward a designation request to OFCA. Under the terms of the MRA, OFCA has up to 60 days to respond to NIST.  

Following recognition, OFCA will work directly with each recognized CB on matters related to the equipment certificates, certification labels and periodic information exchange requirements. Each recognized CB will be assigned a unique 5-character Foreign Certification Body (FCB) Code to be used on certification labels.

Recognized CBs – Extending, Renewing and/or Expanding the Scope of OFCA Recognition

CBs that are recognized by OFCA must apply for an extension or renewal of the recognition prior to the accreditation expiration date.  

Recognized CBs may expand their recognition scope at any time. 

Please submit the following to mra [at] nist.gov (mra[at]nist[dot]gov):

Extending or Renewal CB Recognition - no standards being added

• Extended or renewed ISO/IEC 17065 Scope and Certificate of Accreditation for the CB
• Extended or renewed ISO/IEC 17025 Scope and Certificate of Accreditation for the CB's OFCA recognized in-house lab 
  • If the in-house lab does not cover the OFCA standard covered under the CB’s OFCA recognition, submit the ISO/IEC 17025 Scope and Certificate and the current contractual arrangements of the subcontracted lab(s). 

Expanding Recognition Scope - adding standards

• ISO/IEC 17065 Scope and Certificate of Accreditation for the CB
• ISO/IEC 17025 Scope and Certificate of Accreditation for the CB's OFCA recognized in-house lab
  • If the in-house lab does not cover the OFCA standard(s) being added, submit the ISO/IEC 17025 Scope and Certificate and the current contractual arrangements of the subcontracted lab. 
• A copy of the ISO/IEC 17065 Assessment Report and Findings/Deficiency Report
  • In cases where a standard was added through some other assessment process that did not include an Assessment Report and Deficiency Report, the CB shall provide a letter from the accreditation body detailing the assessment approach used to add the additional standards.
• The fully completed (for a reassessment) or partially completed (for an interim assessment) OFCA Checklist.
  • This must be completed by the AB as part of the technical competency assessment for the additional OFCA standards being added.
  • Any additional special accreditation body assessment details shall be included in the accreditation body letter submitted by the CB. See above.

Special Notice for Radiation Protection Requirements

In Hong Kong, hand-held mobile phones shall comply with the radiation safety requirement specified in HKCA 2001. See Information Note OFCA I 423 "Understanding Radiofrequency (RF) Radiation Safety Standards of Hand-held Mobile Phones" for further information.

In this regard, the following specifications cite HKCA 2001 for radiation protection: HKCA 1033, HKCA 1048, HKCA 1057, HKCA 1064 (applicable to GSM-R mobile station and portable equipment only), HKCA 1073, TAC 002, TAC 008, and TAC 009.

Note:  As of June 24, 2022, when the amended Telecommunications Ordinance (Cap. 106) came into operation, HKCA specifications no longer cover requirements on electrical safety.

In order to be recognized under Phase I and Phase II for these specifications, the CAB must (1) meet a relevant condition of "Passed" specified in this June 2022 OFCA options document and if applicable (2) provide NIST with evidence of contractual arrangements and the Scope of Accreditation of the subcontracted lab.

Additional references to radiation protection requirements are noted in the following documents:

• OFCA MRA 002 Issue 5, June 2022 - Paragraph 7 
• OFCA Checklist (OFCA MRA 004, Issue 18, February 2024) - FCB Checklist for Technical Competence – items 4, 67, 68, and 69

Technical Content Last Revised on February 29, 2024